Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT00352027
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2006-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D014747', 'term': 'Vinblastine'}, {'id': 'D008466', 'term': 'Mechlorethamine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D001761', 'term': 'Bleomycin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jamie.flerlage@stjude.org', 'phone': '901-595-0392', 'title': 'Jamie Flerlage, MD', 'organization': "St. Jude Children's Research Hospital"}, 'certainAgreement': {'otherDetails': 'MSA states Site is unable to publish until all completed case report forms have been delivered to Sponsor, (Study Completion). Site shall have the right to publish after publication of a multi-center publication coordinated by the Sponsor or (12) mths. after Study Completion; provided, that prior to any such publication or public release of such data, Site shall furnish Sponsor with a copy of any proposed publication at least (45)days in advance of the proposed publication or presentation date.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Adverse events were collected from each participant's on-study date through 4 years after completion of therapy.", 'eventGroups': [{'id': 'EG000', 'title': 'Stanford V Chemotherapy', 'description': 'Intermediate risk single arm study defined as\n\n* EITHER Ann Arbor stage IB and IIIA,\n* OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).\n\nParticipants receive 12 weeks of Stanford V chemotherapy:\n\nAdriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)\n\nAfter completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.', 'otherNumAtRisk': 80, 'otherNumAffected': 69, 'seriousNumAtRisk': 80, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Leukocytes (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 111, 'numAffected': 56}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 118, 'numAffected': 56}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 48, 'numAffected': 32}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 73, 'numAffected': 29}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Febrile neutropenia', 'notes': 'Fever of unknown origin without clinically or microbiological documented infection (ANC \\<1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Allergic reaction/hypersensitivity (including drug fever)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '3-year Event-Free Survival Probability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stanford V Chemotherapy', 'description': 'Participants receive 12 weeks of Stanford V chemotherapy:\n\nAdriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)\n\nAfter completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.887', 'groupId': 'OG000', 'lowerLimit': '0.821', 'upperLimit': '0.959'}]}]}], 'analyses': [{'pValue': '0.9970', 'groupIds': ['OG000'], 'groupDescription': 'The association of age with EFS was compared. P values from Score test were computed for the statistical significance.', 'statisticalMethod': 'Cox Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.', 'unitOfMeasure': 'probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease Failure Rate Within Radiation Fields', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stanford V Chemotherapy', 'description': 'Participants receive 12 weeks of Stanford V chemotherapy:\n\nAdriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)\n\nAfter completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1125', 'groupId': 'OG000', 'lowerLimit': '0.05591', 'upperLimit': '0.2076'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Local and Distant Failure for Children Treated With Tailored-field Radiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stanford V Chemotherapy', 'description': 'Participants receive 12 weeks of Stanford V chemotherapy:\n\nAdriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)\n\nAfter completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.'}], 'classes': [{'title': 'Cumulative incidence of distant failure at 3 years', 'categories': [{'measurements': [{'value': '0.0375', 'groupId': 'OG000', 'lowerLimit': '0.0099', 'upperLimit': '0.0967'}]}]}, {'title': 'Cumulative incidence of local failure at 3 years', 'categories': [{'measurements': [{'value': '0.1127', 'groupId': 'OG000', 'lowerLimit': '0.0550', 'upperLimit': '0.1932'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from first enrollment date up to 3 years follow-up', 'description': 'The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field.', 'unitOfMeasure': 'probability that the event occurs', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prognostic Factors for Treatment Failure: Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stanford V Chemotherapy', 'description': 'Participants receive 12 weeks of Stanford V chemotherapy:\n\nAdriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)\n\nAfter completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.9970', 'groupIds': ['OG000'], 'statisticalMethod': 'Cox Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up', 'description': 'Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), PedsQL v.4.0: Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.9', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '74.4', 'spread': '16.5', 'groupId': 'OG001'}, {'value': '75.3', 'spread': '17.8', 'groupId': 'OG002'}, {'value': '83.1', 'spread': '14.6', 'groupId': 'OG003'}, {'value': '84.5', 'spread': '16.6', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.2', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '68.4', 'spread': '23.1', 'groupId': 'OG001'}, {'value': '69.1', 'spread': '24.6', 'groupId': 'OG002'}, {'value': '80.8', 'spread': '17.1', 'groupId': 'OG003'}, {'value': '85.2', 'spread': '15.6', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.3', 'spread': '13', 'groupId': 'OG000'}, {'value': '77.6', 'spread': '15.4', 'groupId': 'OG001'}, {'value': '78.6', 'spread': '16.8', 'groupId': 'OG002'}, {'value': '84.3', 'spread': '15.1', 'groupId': 'OG003'}, {'value': '84.3', 'spread': '17.9', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.6', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '75.3', 'spread': '19.3', 'groupId': 'OG001'}, {'value': '75.7', 'spread': '20.8', 'groupId': 'OG002'}, {'value': '84.5', 'spread': '17.8', 'groupId': 'OG003'}, {'value': '81.6', 'spread': '24.1', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.9', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '88.6', 'spread': '13.0', 'groupId': 'OG001'}, {'value': '88.0', 'spread': '15.6', 'groupId': 'OG002'}, {'value': '90.1', 'spread': '12.5', 'groupId': 'OG003'}, {'value': '91.1', 'spread': '13.6', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.1', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '69.5', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '72.6', 'spread': '22.2', 'groupId': 'OG002'}, {'value': '78.4', 'spread': '20.6', 'groupId': 'OG003'}, {'value': '81.3', 'spread': '21.6', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), PedsQL v.3.0: Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.1', 'spread': '15.3', 'groupId': 'OG001'}, {'value': '74.2', 'spread': '16.8', 'groupId': 'OG002'}, {'value': '81.7', 'spread': '14.6', 'groupId': 'OG003'}, {'value': '83.5', 'spread': '17.2', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '25.4', 'groupId': 'OG001'}, {'value': '71.5', 'spread': '24.6', 'groupId': 'OG002'}, {'value': '79.9', 'spread': '25.1', 'groupId': 'OG003'}, {'value': '88.0', 'spread': '17.8', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), PedsQL v.3.0: Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'spread': '24.0', 'groupId': 'OG001'}, {'value': '60.1', 'spread': '23.5', 'groupId': 'OG002'}, {'value': '76.7', 'spread': '20.9', 'groupId': 'OG003'}, {'value': '81.6', 'spread': '23.1', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.8', 'spread': '29.0', 'groupId': 'OG001'}, {'value': '70.9', 'spread': '32.6', 'groupId': 'OG002'}, {'value': '68.1', 'spread': '37.3', 'groupId': 'OG003'}, {'value': '80.1', 'spread': '25.9', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.2', 'spread': '15.5', 'groupId': 'OG001'}, {'value': '82', 'spread': '22.5', 'groupId': 'OG002'}, {'value': '89.4', 'spread': '16.6', 'groupId': 'OG003'}, {'value': '87.3', 'spread': '19.1', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), PedsQL v.3.0: Worry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.2', 'spread': '22.5', 'groupId': 'OG001'}, {'value': '72.2', 'spread': '24.7', 'groupId': 'OG002'}, {'value': '74.5', 'spread': '27.2', 'groupId': 'OG003'}, {'value': '76.0', 'spread': '25.0', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.1', 'spread': '19.4', 'groupId': 'OG001'}, {'value': '78.2', 'spread': '21.4', 'groupId': 'OG002'}, {'value': '87.0', 'spread': '17.3', 'groupId': 'OG003'}, {'value': '82.0', 'spread': '23.2', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.6', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '81.3', 'spread': '22.6', 'groupId': 'OG002'}, {'value': '81.4', 'spread': '22.4', 'groupId': 'OG003'}, {'value': '84.7', 'spread': '22.9', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), PedsQL v.3.0: Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.7', 'spread': '19.9', 'groupId': 'OG001'}, {'value': '83.0', 'spread': '22.5', 'groupId': 'OG002'}, {'value': '87.2', 'spread': '22.8', 'groupId': 'OG003'}, {'value': '89.0', 'spread': '19.3', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life (QoL), Symptom Distress Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '18.1', 'spread': '6.1', 'groupId': 'OG002'}, {'value': '15.1', 'spread': '4.8', 'groupId': 'OG003'}, {'value': '14.3', 'spread': '5.3', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "The patient's degree of discomfort from specific treatment-related symptoms across multiple time points.\n\nInstrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.6', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '69.1', 'spread': '17.9', 'groupId': 'OG001'}, {'value': '72.3', 'spread': '18.5', 'groupId': 'OG002'}, {'value': '77.8', 'spread': '16.3', 'groupId': 'OG003'}, {'value': '83.5', 'spread': '16.4', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.8', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '65.3', 'spread': '23.2', 'groupId': 'OG001'}, {'value': '67.3', 'spread': '25.2', 'groupId': 'OG002'}, {'value': '73.6', 'spread': '21.3', 'groupId': 'OG003'}, {'value': '84.6', 'spread': '18.6', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.2', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '71.0', 'spread': '16.7', 'groupId': 'OG001'}, {'value': '74.1', 'spread': '17.9', 'groupId': 'OG002'}, {'value': '79.0', 'spread': '16.1', 'groupId': 'OG003'}, {'value': '88.0', 'spread': '17.0', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.7', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '65.4', 'spread': '18.4', 'groupId': 'OG001'}, {'value': '68.1', 'spread': '23.7', 'groupId': 'OG002'}, {'value': '73.0', 'spread': '20.1', 'groupId': 'OG003'}, {'value': '82.0', 'spread': '18.9', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.1', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '83.0', 'spread': '16.0', 'groupId': 'OG001'}, {'value': '80.7', 'spread': '18.5', 'groupId': 'OG002'}, {'value': '85.1', 'spread': '16.3', 'groupId': 'OG003'}, {'value': '89.1', 'spread': '16.8', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.4', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '62.8', 'spread': '25.0', 'groupId': 'OG001'}, {'value': '70.8', 'spread': '22.7', 'groupId': 'OG002'}, {'value': '75.6', 'spread': '20.8', 'groupId': 'OG003'}, {'value': '78.9', 'spread': '21.2', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.7', 'spread': '16.7', 'groupId': 'OG001'}, {'value': '69.3', 'spread': '19.0', 'groupId': 'OG002'}, {'value': '74.5', 'spread': '17.7', 'groupId': 'OG003'}, {'value': '80.0', 'spread': '16.4', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '24.3', 'groupId': 'OG001'}, {'value': '61.8', 'spread': '30.5', 'groupId': 'OG002'}, {'value': '73.1', 'spread': '25.9', 'groupId': 'OG003'}, {'value': '82.7', 'spread': '23.4', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '24.4', 'groupId': 'OG001'}, {'value': '57.4', 'spread': '29.2', 'groupId': 'OG002'}, {'value': '72.2', 'spread': '26.6', 'groupId': 'OG003'}, {'value': '83.2', 'spread': '22.6', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'spread': '32.1', 'groupId': 'OG001'}, {'value': '60.0', 'spread': '35.0', 'groupId': 'OG002'}, {'value': '63.1', 'spread': '36.6', 'groupId': 'OG003'}, {'value': '73.8', 'spread': '31.7', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.9', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '72.6', 'spread': '28.4', 'groupId': 'OG002'}, {'value': '78.5', 'spread': '26.8', 'groupId': 'OG003'}, {'value': '81.8', 'spread': '20.8', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '24.5', 'groupId': 'OG001'}, {'value': '69.2', 'spread': '25.3', 'groupId': 'OG002'}, {'value': '71.9', 'spread': '24.1', 'groupId': 'OG003'}, {'value': '78.7', 'spread': '19.4', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.6', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '79.5', 'spread': '20.4', 'groupId': 'OG002'}, {'value': '78.6', 'spread': '21.8', 'groupId': 'OG003'}, {'value': '79.9', 'spread': '23.4', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.9', 'spread': '22.9', 'groupId': 'OG001'}, {'value': '72.2', 'spread': '21.9', 'groupId': 'OG002'}, {'value': '73.7', 'spread': '24.2', 'groupId': 'OG003'}, {'value': '76.3', 'spread': '24.4', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.2', 'spread': '25.9', 'groupId': 'OG001'}, {'value': '80.4', 'spread': '24.9', 'groupId': 'OG002'}, {'value': '80.3', 'spread': '22.6', 'groupId': 'OG003'}, {'value': '84.3', 'spread': '20.3', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent and Patient Scores at Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Parent and Patient Scores at Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Parent and Patient Scores at Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'Parent and Patient Scores at After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Parent and Patient Scores at Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.9', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '13.8', 'groupId': 'OG001'}, {'value': '-4.8', 'spread': '14.7', 'groupId': 'OG002'}, {'value': '-5', 'spread': '10.7', 'groupId': 'OG003'}, {'value': '-2.9', 'spread': '14.8', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.265', 'groupIds': ['OG000'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.057', 'groupIds': ['OG001'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.079', 'groupIds': ['OG002'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.025', 'groupIds': ['OG003'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.680', 'groupIds': ['OG004'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent and Patient Scores at Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Parent and Patient Scores at Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Parent and Patient Scores at Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'Parent and Patient Scores at After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Parent and Patient Scores at Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.9', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '16.9', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '23.3', 'groupId': 'OG002'}, {'value': '-5.4', 'spread': '15.8', 'groupId': 'OG003'}, {'value': '-2', 'spread': '19.1', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.563', 'groupIds': ['OG000'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.563', 'groupIds': ['OG001'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.563', 'groupIds': ['OG002'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.184', 'groupIds': ['OG003'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.563', 'groupIds': ['OG004'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent and Patient Scores at Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Parent and Patient Scores at Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Parent and Patient Scores at Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'Parent and Patient Scores at After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Parent and Patient Scores at Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.8', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '-6.3', 'spread': '13.2', 'groupId': 'OG002'}, {'value': '-5.6', 'spread': '11.2', 'groupId': 'OG003'}, {'value': '-3.3', 'spread': '14.2', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.319', 'groupIds': ['OG000'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.010', 'groupIds': ['OG001'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.002', 'groupIds': ['OG002'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.015', 'groupIds': ['OG003'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.588', 'groupIds': ['OG004'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent and Patient Scores at Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Parent and Patient Scores at Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Parent and Patient Scores at Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'Parent and Patient Scores at After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Parent and Patient Scores at Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.9', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '-9.4', 'spread': '17.9', 'groupId': 'OG001'}, {'value': '-8.0', 'spread': '14.2', 'groupId': 'OG002'}, {'value': '-10.8', 'spread': '14.3', 'groupId': 'OG003'}, {'value': '-1.7', 'spread': '18.8', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.071', 'groupIds': ['OG000'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG002'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG003'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.707', 'groupIds': ['OG004'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent and Patient Scores at Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Parent and Patient Scores at Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Parent and Patient Scores at Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'Parent and Patient Scores at After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Parent and Patient Scores at Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.3', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '-5.7', 'spread': '15.3', 'groupId': 'OG001'}, {'value': '-7.4', 'spread': '17.7', 'groupId': 'OG002'}, {'value': '-5.0', 'spread': '12.6', 'groupId': 'OG003'}, {'value': '-3.3', 'spread': '16.4', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.042', 'groupIds': ['OG000'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.025', 'groupIds': ['OG001'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.013', 'groupIds': ['OG002'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.027', 'groupIds': ['OG003'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.243', 'groupIds': ['OG004'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent and Patient Scores at Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Parent and Patient Scores at Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Parent and Patient Scores at Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'Parent and Patient Scores at After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Parent and Patient Scores at Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '19.5', 'groupId': 'OG001'}, {'value': '-4.1', 'spread': '21.0', 'groupId': 'OG002'}, {'value': '-3.4', 'spread': '16.7', 'groupId': 'OG003'}, {'value': '-4.3', 'spread': '16.4', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.546', 'groupIds': ['OG000'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.242', 'groupIds': ['OG001'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.372', 'groupIds': ['OG002'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.503', 'groupIds': ['OG003'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.372', 'groupIds': ['OG004'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent and Patient Scores at Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Parent and Patient Scores at Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Parent and Patient Scores at Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'Parent and Patient Scores at After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Parent and Patient Scores at Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '13', 'groupId': 'OG001'}, {'value': '-5.2', 'spread': '13.8', 'groupId': 'OG002'}, {'value': '-4.5', 'spread': '12.5', 'groupId': 'OG003'}, {'value': '-5', 'spread': '16.8', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.558', 'groupIds': ['OG001'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.039', 'groupIds': ['OG002'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.162', 'groupIds': ['OG003'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.162', 'groupIds': ['OG004'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent and Patient Scores at Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Parent and Patient Scores at Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Parent and Patient Scores at Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'Parent and Patient Scores at After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Parent and Patient Scores at Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '16.5', 'groupId': 'OG001'}, {'value': '-9.5', 'spread': '23.6', 'groupId': 'OG002'}, {'value': '-5.6', 'spread': '23.4', 'groupId': 'OG003'}, {'value': '-5.4', 'spread': '19.8', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.381', 'groupIds': ['OG001'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.006', 'groupIds': ['OG002'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.277', 'groupIds': ['OG003'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.134', 'groupIds': ['OG004'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent and Patient Scores at Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Parent and Patient Scores at Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Parent and Patient Scores at Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'Parent and Patient Scores at After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Parent and Patient Scores at Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '15.8', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '21.9', 'groupId': 'OG002'}, {'value': '-3.0', 'spread': '22.4', 'groupId': 'OG003'}, {'value': '-1.1', 'spread': '22.2', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.629', 'groupIds': ['OG001'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.629', 'groupIds': ['OG002'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.629', 'groupIds': ['OG003'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.858', 'groupIds': ['OG004'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent and Patient Scores at Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Parent and Patient Scores at Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Parent and Patient Scores at Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'Parent and Patient Scores at After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Parent and Patient Scores at Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '28.1', 'groupId': 'OG001'}, {'value': '-9.3', 'spread': '29.9', 'groupId': 'OG002'}, {'value': '-2.2', 'spread': '32.7', 'groupId': 'OG003'}, {'value': '-8.7', 'spread': '27.7', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.744', 'groupIds': ['OG001'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.075', 'groupIds': ['OG002'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.512', 'groupIds': ['OG003'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.088', 'groupIds': ['OG004'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent and Patient Scores at Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Parent and Patient Scores at Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Parent and Patient Scores at Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'Parent and Patient Scores at After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Parent and Patient Scores at Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.1', 'spread': '21.9', 'groupId': 'OG001'}, {'value': '-8.8', 'spread': '26.4', 'groupId': 'OG002'}, {'value': '-7.9', 'spread': '23.7', 'groupId': 'OG003'}, {'value': '-6.6', 'spread': '26.7', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.078', 'groupIds': ['OG001'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.041', 'groupIds': ['OG002'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.078', 'groupIds': ['OG003'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.078', 'groupIds': ['OG004'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent and Patient Scores at Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Parent and Patient Scores at Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Parent and Patient Scores at Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'Parent and Patient Scores at After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Parent and Patient Scores at Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '21.7', 'groupId': 'OG001'}, {'value': '-3.9', 'spread': '26.5', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '20.4', 'groupId': 'OG003'}, {'value': '-0.5', 'spread': '19.9', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.739', 'groupIds': ['OG001'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.739', 'groupIds': ['OG002'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.739', 'groupIds': ['OG003'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.739', 'groupIds': ['OG004'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent and Patient Scores at Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Parent and Patient Scores at Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Parent and Patient Scores at Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'Parent and Patient Scores at After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Parent and Patient Scores at Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '20.7', 'groupId': 'OG001'}, {'value': '0.14', 'spread': '19', 'groupId': 'OG002'}, {'value': '-8.0', 'spread': '19', 'groupId': 'OG003'}, {'value': '-4.0', 'spread': '20', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.933', 'groupIds': ['OG001'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.933', 'groupIds': ['OG002'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.051', 'groupIds': ['OG003'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0779', 'groupIds': ['OG004'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent and Patient Scores at Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Parent and Patient Scores at Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Parent and Patient Scores at Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'Parent and Patient Scores at After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Parent and Patient Scores at Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '21.0', 'groupId': 'OG001'}, {'value': '-9.5', 'spread': '22.5', 'groupId': 'OG002'}, {'value': '-5.9', 'spread': '25.7', 'groupId': 'OG003'}, {'value': '-9.3', 'spread': '20.5', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.415', 'groupIds': ['OG001'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.005', 'groupIds': ['OG002'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.245', 'groupIds': ['OG003'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.005', 'groupIds': ['OG004'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent and Patient Scores at Pre-therapy', 'description': 'Evaluation completed prior to the start of treatment.'}, {'id': 'OG001', 'title': 'Parent and Patient Scores at Week 8', 'description': 'Evaluation completed following 2 courses of therapy, approximately week 8 after start.'}, {'id': 'OG002', 'title': 'Parent and Patient Scores at Week 12', 'description': 'Evaluation completed following 4 courses of therapy, approximately week 16 after start.'}, {'id': 'OG003', 'title': 'Parent and Patient Scores at After Radiation', 'description': 'Evaluation completed following radiation therapy.'}, {'id': 'OG004', 'title': 'Parent and Patient Scores at Off-therapy', 'description': 'Evaluation completed approximately 3-6 months following completion of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '26.4', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '25.2', 'groupId': 'OG002'}, {'value': '-7.4', 'spread': '25.5', 'groupId': 'OG003'}, {'value': '-6.3', 'spread': '21.1', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.814', 'groupIds': ['OG001'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.553', 'groupIds': ['OG002'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.173', 'groupIds': ['OG003'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.122', 'groupIds': ['OG004'], 'pValueComment': 'P-values are shown after correction for multiple testing using the False Discovery Rate Method.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.'}, {'type': 'SECONDARY', 'title': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QoL Participants', 'description': 'All participants who completed the required questionnaires during at least one time point for evaluating this outcome.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.46', 'groupId': 'OG000', 'lowerLimit': '-1.64', 'upperLimit': '-1.27'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Generalized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress instruments aggregated across multiple time points \\[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.'}, {'type': 'SECONDARY', 'title': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QoL Participants', 'description': 'All participants who completed the required questionnaires during at least one time point for evaluating this outcome.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'groupId': 'OG000', 'lowerLimit': '-2.27', 'upperLimit': '-1.54'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Generallized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress instruments aggregated across multiple time points \\[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.'}, {'type': 'SECONDARY', 'title': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QoL Participants', 'description': 'All participants who completed the required questionnaires during at least one time point for evaluating this outcome.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.92', 'groupId': 'OG000', 'lowerLimit': '-1.26', 'upperLimit': '-0.58'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Generallized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress instruments aggregated across multiple time points \\[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.'}, {'type': 'SECONDARY', 'title': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QoL Participants', 'description': 'All participants who completed the required questionnaires during at least one time point for evaluating this outcome.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.56', 'groupId': 'OG000', 'lowerLimit': '-1.95', 'upperLimit': '-1.16'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Generallized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress instruments aggregated across multiple time points \\[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.'}, {'type': 'SECONDARY', 'title': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QoL Participants', 'description': 'All participants who completed the required questionnaires during at least one time point for evaluating this outcome.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.79', 'groupId': 'OG000', 'lowerLimit': '-0.98', 'upperLimit': '-0.59'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Generallized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress instruments aggregated across multiple time points \\[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.'}, {'type': 'SECONDARY', 'title': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QoL Participants', 'description': 'All participants who completed the required questionnaires during at least one time point for evaluating this outcome.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.21', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '-0.72'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Generallized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress instruments aggregated across multiple time points \\[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.'}, {'type': 'SECONDARY', 'title': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QoL Participants', 'description': 'All participants who completed the required questionnaires during at least one time point for evaluating this outcome.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.41', 'groupId': 'OG000', 'lowerLimit': '-1.71', 'upperLimit': '-1.11'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Generalized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.'}, {'type': 'SECONDARY', 'title': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QoL Participants', 'description': 'All participants who completed the required questionnaires during at least one time point for evaluating this outcome.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.52', 'groupId': 'OG000', 'lowerLimit': '-3.02', 'upperLimit': '-2.02'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Generalized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.'}, {'type': 'SECONDARY', 'title': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QoL Participants', 'description': 'All participants who completed the required questionnaires during at least one time point for evaluating this outcome.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.31', 'groupId': 'OG000', 'lowerLimit': '-2.85', 'upperLimit': '-1.77'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Generalized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.'}, {'type': 'SECONDARY', 'title': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QoL Participants', 'description': 'All participants who completed the required questionnaires during at least one time point for evaluating this outcome.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.87', 'groupId': 'OG000', 'lowerLimit': '-1.49', 'upperLimit': '-0.26'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000'], 'statisticalMethod': 'Generalized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.'}, {'type': 'SECONDARY', 'title': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QoL Participants', 'description': 'All participants who completed the required questionnaires during at least one time point for evaluating this outcome.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.96', 'groupId': 'OG000', 'lowerLimit': '-1.43', 'upperLimit': '-0.50'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Generalized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.'}, {'type': 'SECONDARY', 'title': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QoL Participants', 'description': 'All participants who completed the required questionnaires during at least one time point for evaluating this outcome.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.06', 'groupId': 'OG000', 'lowerLimit': '-1.48', 'upperLimit': '-0.65'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Generalized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.'}, {'type': 'SECONDARY', 'title': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QoL Participants', 'description': 'All participants who completed the required questionnaires during at least one time point for evaluating this outcome.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.46', 'groupId': 'OG000', 'lowerLimit': '-1.87', 'upperLimit': '-1.04'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Generalized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.'}, {'type': 'SECONDARY', 'title': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QoL Participants', 'description': 'All participants who completed the required questionnaires during at least one time point for evaluating this outcome.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.20', 'groupId': 'OG000', 'lowerLimit': '-1.68', 'upperLimit': '-0.72'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Generalized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.'}, {'type': 'SECONDARY', 'title': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QoL Participants', 'description': 'All participants who completed the required questionnaires during at least one time point for evaluating this outcome.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.35', 'groupId': 'OG000', 'lowerLimit': '-1.74', 'upperLimit': '-0.96'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Generalized Estimating Equations (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.'}, {'type': 'SECONDARY', 'title': '3-year Event-free Survival (EFS) Probability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOD05 Participants', 'description': 'Current study defined as Intermediate Risk single arm classified as:\n\n* EITHER Ann Arbor stage IB and IIIA,\n* OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).\n\nParticipants receive 12 weeks of Stanford V chemotherapy:\n\nAdriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)\n\nAfter completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.'}, {'id': 'OG001', 'title': 'HOD99 Participants', 'description': "Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:\n\n* EITHER Ann Arbor stage IB and IIIA,\n* OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).\n\nParticipants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."}], 'classes': [{'categories': [{'measurements': [{'value': '0.887', 'groupId': 'OG000', 'lowerLimit': '0.821', 'upperLimit': '0.959'}, {'value': '0.844', 'groupId': 'OG001', 'lowerLimit': '0.745', 'upperLimit': '0.957'}]}]}], 'analyses': [{'pValue': '0.908', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.', 'unitOfMeasure': 'probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '3-year Overall Survival (OS) Probability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOD05 Participants', 'description': 'Current study defined as Intermediate Risk single arm classified as:\n\n* EITHER Ann Arbor stage IB and IIIA,\n* OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).\n\nParticipants receive 12 weeks of Stanford V chemotherapy:\n\nAdriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)\n\nAfter completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.'}, {'id': 'OG001', 'title': 'HOD99 Participants', 'description': "Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:\n\nEITHER Ann Arbor stage IB and IIIA, OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).\n\nParticipants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '0.978', 'groupId': 'OG001', 'lowerLimit': '0.936', 'upperLimit': '1.00'}]}]}], 'analyses': [{'pValue': '0.178', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '3-years', 'description': 'Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.', 'unitOfMeasure': 'probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '3-year Local Failure-free Survival Probability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HOD05 Participants', 'description': 'Current study defined as Intermediate Risk single arm classified as:\n\n* EITHER Ann Arbor stage IB and IIIA,\n* OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).\n\nParticipants receive 12 weeks of Stanford V chemotherapy:\n\nAdriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)\n\nAfter completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.'}, {'id': 'OG001', 'title': 'HOD99 Participants', 'description': "Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:\n\nEITHER Ann Arbor stage IB and IIIA, OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).\n\nParticipants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."}], 'classes': [{'categories': [{'measurements': [{'value': '0.887', 'groupId': 'OG000', 'lowerLimit': '0.821', 'upperLimit': '0.959'}, {'value': '0.932', 'groupId': 'OG001', 'lowerLimit': '0.860', 'upperLimit': '1.00'}]}]}], 'analyses': [{'pValue': '0.411', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.', 'unitOfMeasure': 'probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Toxicities With Grade >1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'HOD05 - Grade 2', 'description': 'Participants in current study.'}, {'id': 'OG001', 'title': 'HOD05 - Grade 3', 'description': 'Participants in current study.'}, {'id': 'OG002', 'title': 'HOD05 - Grade 4', 'description': 'Participants in current study.'}, {'id': 'OG003', 'title': 'HOD05 - Grade 5', 'description': 'Participants in current study.'}, {'id': 'OG004', 'title': 'HOD99 - Grade 2', 'description': "Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital."}, {'id': 'OG005', 'title': 'HOD99 - Grade 3', 'description': "Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital."}, {'id': 'OG006', 'title': 'HOD99 - Grade 4', 'description': "Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital."}, {'id': 'OG007', 'title': 'HOD99 - Grade 5', 'description': "Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital."}], 'classes': [{'title': 'Alanine transaminase (ALT)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Aspartate transaminase (AST)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Allergic reaction/hypersensitivity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Febrile neutropenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Fever (in the absence of neutropenia)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Glucose', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'GGT (gamma-Glutamyltranspeptidase)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Hypoxia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Ileus, GI (functional obstruction of bowel)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Infection with Grade 3 or 4 neutrophils', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Infection - Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Infection with normal ANC or Grade 1-2 neutrophils', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Infection with unknown ANC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Insomnia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Leukocytes (total WBC)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Mucositis/stomatitis (functional/symptomatic)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Neuropathy: motor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Neuropathy: sensory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Neutrophils/granulocytes (ANC/AGC)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Phosphate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Potassium', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Sodium', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Syndromes - Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Thrombosis/embolism (vascular access-related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Thrombosis/thrombus/embolism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'populationDescription': "Toxicities reported below for the current study (HOD05) include all reported toxicities from a participant's on-study date through 2/17/2016. Toxicities reported below for the HOD99 study include all those reported from a participant's on-study date through their off-study date."}, {'type': 'SECONDARY', 'title': 'Prognostic Factors for Treatment Failure: Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stanford V Chemotherapy', 'description': 'Participants receive 12 weeks of Stanford V chemotherapy:\n\nAdriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)\n\nAfter completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.'}], 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.4318', 'groupIds': ['OG000'], 'statisticalMethod': 'Cox Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '3 years follow-up', 'description': 'Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prognostic Factors for Treatment Failure: Histology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stanford V Chemotherapy', 'description': 'Participants receive 12 weeks of Stanford V chemotherapy:\n\nAdriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)\n\nAfter completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.'}], 'classes': [{'title': 'Classical, Nodular Sclerosing', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.2199', 'groupIds': ['OG000'], 'statisticalMethod': 'Cox Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '3 years follow-up', 'description': 'Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prognostic Factors for Treatment Failure: Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stanford V Chemotherapy', 'description': 'Participants receive 12 weeks of Stanford V chemotherapy:\n\nAdriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)\n\nAfter completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.'}], 'classes': [{'title': 'Stage <III', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Stage ≥III', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.8946', 'groupIds': ['OG000'], 'statisticalMethod': 'Cox Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up', 'description': 'Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage \\<III showed a better outcome but was not statistically significant.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Year 1 Off Therapy', 'description': 'Evaluation completed approximately 1 year following completion of therapy.'}, {'id': 'OG001', 'title': 'Year 2 Off Therapy', 'description': 'Evaluation completed approximately 2 years following completion of therapy.'}, {'id': 'OG002', 'title': 'Year 5 Off Therapy', 'description': 'Evaluation completed approximately 5 years following completion of therapy.'}, {'id': 'OG003', 'title': 'Year 10 Off Therapy', 'description': 'Evaluation completed approximately 10 years following completion of therapy.'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1, 2, 5, and 10 years post therapy', 'description': 'Echocardiograms will be carried out on the patient at 1, 2, 5, and 10 years after therapy. Outcomes will be categorized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At each time point, a participant underwent an Echocardiogram (ECHO). Data was unavailable for patients who did not undergo the Echocardiogram at that time point.'}, {'type': 'SECONDARY', 'title': 'Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Year 1 Off Therapy', 'description': 'Evaluation completed approximately 1 year following completion of therapy.'}, {'id': 'OG001', 'title': 'Year 2 Off Therapy', 'description': 'Evaluation completed approximately 2 years following completion of therapy.'}, {'id': 'OG002', 'title': 'Year 5 Off Therapy', 'description': 'Evaluation completed approximately 5 years following completion of therapy.'}, {'id': 'OG003', 'title': 'Year 10 Off Therapy', 'description': 'Evaluation completed approximately 10 years following completion of therapy.'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1, 2, 5, and 10 years post therapy', 'description': 'Electrocardiograms (EKGs) will be conducted on the patient at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, determined by the test outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At each time point, a participant underwent an Electrocardiogram (EKG). Data was unavailable for patients who did not undergo the Electrocardiogram at that time point.'}, {'type': 'SECONDARY', 'title': 'Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Year 1 Off Therapy', 'description': 'Evaluation completed approximately 1 year following completion of therapy.'}, {'id': 'OG001', 'title': 'Year 2 Off Therapy', 'description': 'Evaluation completed approximately 2 years following completion of therapy.'}, {'id': 'OG002', 'title': 'Year 5 Off Therapy', 'description': 'Evaluation completed approximately 5 years following completion of therapy.'}, {'id': 'OG003', 'title': 'Year 10 Off Therapy', 'description': 'Evaluation completed approximately 10 years following completion of therapy.'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1, 2, 5, and 10 years post therapy', 'description': 'Patient pulmonary function will undergo assessment at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, depending on the test results.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At each time point, participants who received mediastinal/lung radiation or bleomycin underwent pulmonary function (PFT) assessment. Data was unavailable for patients who did not undergo the pulmonary function test at that time point.'}, {'type': 'SECONDARY', 'title': 'Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Year 1 Off Therapy', 'description': 'Evaluation completed approximately 1 year following completion of therapy.'}, {'id': 'OG001', 'title': 'Year 2 Off Therapy', 'description': 'Evaluation completed approximately 2 years following completion of therapy.'}, {'id': 'OG002', 'title': 'Year 5 Off Therapy', 'description': 'Evaluation completed approximately 5 years following completion of therapy.'}, {'id': 'OG003', 'title': 'Year 10 Off Therapy', 'description': 'Evaluation completed approximately 10 years following completion of therapy.'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}, {'title': 'Hypothyroid', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Hyperthyroid', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Thyroid Nodule', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1, 2, 5, and 10 years post therapy', 'description': "For patients that received cervical radiation, TSH laboratory testing will be conducted at 1, 2, 5 and 10 years. TSH results will be categorized as Normal, Hypothyroid, Hyperthyroid, or Thyroid Nodule, depending on the test's findings.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At each time point, participants who received cervical and upper mediastinal radiation underwent TSH laboratory test. Data was unavailable for patients who did not undergo the TSH test at that time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stanford V Chemotherapy', 'description': 'Participants receive 12 weeks of Stanford V chemotherapy:\n\nAdriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)\n\nAfter completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were enrolled between July 2006 and March 2012.', 'preAssignmentDetails': 'One participant was determined to be ineligible after enrollment and prior to start of therapy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Stanford V Chemotherapy', 'description': 'Participants receive 12 weeks of Stanford V chemotherapy:\n\nAdriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)\n\nAfter completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.10', 'spread': '3.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Participating Site Location', 'classes': [{'title': 'Dana Farber Cancer Institute, Boston, MA', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Main Medical Center, Portland, ME', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Massachusetts General Hospital, Boston, MA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': "Rady Children's Hospital, San Diego, CA", 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': "St. Jude Children's Research Hospital, Memphis, TN", 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': 'Stanford University Medical Center, Palo Alto, CA', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-01', 'studyFirstSubmitDate': '2006-07-13', 'resultsFirstSubmitDate': '2016-04-27', 'studyFirstSubmitQcDate': '2006-07-13', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-19', 'studyFirstPostDateStruct': {'date': '2006-07-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year Event-Free Survival Probability', 'timeFrame': '3 years', 'description': 'The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.'}], 'secondaryOutcomes': [{'measure': 'Disease Failure Rate Within Radiation Fields', 'timeFrame': '3 years', 'description': 'Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).'}, {'measure': 'Local and Distant Failure for Children Treated With Tailored-field Radiation', 'timeFrame': 'from first enrollment date up to 3 years follow-up', 'description': 'The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field.'}, {'measure': 'Prognostic Factors for Treatment Failure: Age', 'timeFrame': '5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up', 'description': 'Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance.'}, {'measure': 'Patient Quality of Life (QoL), PedsQL v.4.0: Total Score', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."}, {'measure': 'Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."}, {'measure': 'Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."}, {'measure': 'Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."}, {'measure': 'Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."}, {'measure': 'Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."}, {'measure': 'Patient Quality of Life (QoL), PedsQL v.3.0: Total Score', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Patient Quality of Life (QoL), PedsQL v.3.0: Nausea', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Patient Quality of Life (QoL), PedsQL v.3.0: Worry', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Patient Quality of Life (QoL), PedsQL v.3.0: Communication', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Patient QOL will be measured at multiple time points to assess the patient's functioning.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Patient Quality of Life (QoL), Symptom Distress Scale', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "The patient's degree of discomfort from specific treatment-related symptoms across multiple time points.\n\nInstrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50."}, {'measure': 'Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."}, {'measure': 'Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."}, {'measure': 'Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."}, {'measure': 'Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."}, {'measure': 'Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."}, {'measure': 'Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."}, {'measure': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': "Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."}, {'measure': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.'}, {'measure': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.'}, {'measure': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.'}, {'measure': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.'}, {'measure': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.'}, {'measure': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.'}, {'measure': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.'}, {'measure': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.'}, {'measure': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.'}, {'measure': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.'}, {'measure': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.'}, {'measure': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.'}, {'measure': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.'}, {'measure': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.'}, {'measure': 'Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy', 'description': 'Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.'}, {'measure': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress instruments aggregated across multiple time points \\[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.'}, {'measure': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress instruments aggregated across multiple time points \\[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.'}, {'measure': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress instruments aggregated across multiple time points \\[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.'}, {'measure': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress instruments aggregated across multiple time points \\[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.'}, {'measure': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress instruments aggregated across multiple time points \\[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.'}, {'measure': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress instruments aggregated across multiple time points \\[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.'}, {'measure': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.'}, {'measure': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.'}, {'measure': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.'}, {'measure': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.'}, {'measure': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.'}, {'measure': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.'}, {'measure': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.'}, {'measure': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.'}, {'measure': 'Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication', 'timeFrame': '6 months after the completion of therapy', 'description': 'Relationship between quality of life and symptom distress across multiple time points \\[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.\n\nInstrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.'}, {'measure': '3-year Event-free Survival (EFS) Probability', 'timeFrame': '3 years', 'description': 'Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.'}, {'measure': '3-year Overall Survival (OS) Probability', 'timeFrame': '3-years', 'description': 'Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.'}, {'measure': '3-year Local Failure-free Survival Probability', 'timeFrame': '3 years', 'description': 'Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.'}, {'measure': 'Toxicities With Grade >1', 'timeFrame': '3 years', 'description': 'Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.'}, {'measure': 'Prognostic Factors for Treatment Failure: Gender', 'timeFrame': '3 years follow-up', 'description': 'Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.'}, {'measure': 'Prognostic Factors for Treatment Failure: Histology', 'timeFrame': '3 years follow-up', 'description': 'Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.'}, {'measure': 'Prognostic Factors for Treatment Failure: Stage', 'timeFrame': '5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up', 'description': 'Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage \\<III showed a better outcome but was not statistically significant.'}, {'measure': 'Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)', 'timeFrame': '1, 2, 5, and 10 years post therapy', 'description': 'Echocardiograms will be carried out on the patient at 1, 2, 5, and 10 years after therapy. Outcomes will be categorized.'}, {'measure': 'Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)', 'timeFrame': '1, 2, 5, and 10 years post therapy', 'description': 'Electrocardiograms (EKGs) will be conducted on the patient at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, determined by the test outcome.'}, {'measure': 'Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)', 'timeFrame': '1, 2, 5, and 10 years post therapy', 'description': 'Patient pulmonary function will undergo assessment at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, depending on the test results.'}, {'measure': 'Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)', 'timeFrame': '1, 2, 5, and 10 years post therapy', 'description': "For patients that received cervical radiation, TSH laboratory testing will be conducted at 1, 2, 5 and 10 years. TSH results will be categorized as Normal, Hypothyroid, Hyperthyroid, or Thyroid Nodule, depending on the test's findings."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Hodgkin's Disease"], 'conditions': ["Hodgkin's Lymphoma"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}, {'url': 'http://www.stjude.org/protocols', 'label': 'Clinical Trials Open at St. Jude'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.', 'detailedDescription': 'Treatment Plan Description:\n\nAdriamycin 25 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11\n\nVinblastine 6 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11\n\nNitrogen Mustard 6mg/m2 IV on Day 1 of weeks 1, 5, and 9\n\nCyclophosphamide 650 mg/m2 IV Day 1 of weeks 1, 5, 9(when Nitrogen Mustard was not available due to national shortage)\n\nVincristine 1.4 mg/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12\n\nBleomycin 5 units/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12\n\nEtoposide 60 mg/m2 IV Days 1,2 of weeks 3, 7, 11\n\nPrednisone\\* 40 mg/m2/day divided in 3 doses PO Every other day of weeks 1-12\n\nG-CSF (only as needed in case of severe myelo-suppression requiring treatment delay) 5 mcg/kg SC Days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)\n\n\\* Prednisone taper is foreseen for the last 2 weeks of therapy. Patients will be treated with 12 weeks of Stanford V chemotherapy in the schedule outlined above. Patients will then receive radiation therapy after completion of 12 weeks of chemotherapy. The radiation dose to individual nodal sites will be based on response after 8 weeks of chemotherapy: 15 Gy for areas achieving a complete response and 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is less than or equal to 21 years of age\n* Patient has a confirmed diagnosis of previously untreated Hodgkin lymphoma\n* Has Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal involvement (3 or more sites), or bulky mediastinal adenopathy.\n\nExclusion Criteria:\n\n* Patients with favorable risk features\n* Patients with unfavorable risk features\n* Patients who have received prior therapy for Hodgkin lymphoma.'}, 'identificationModule': {'nctId': 'NCT00352027', 'briefTitle': 'Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': 'HOD05'}, 'secondaryIdInfos': [{'id': 'NCI-2011-01253', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trial Registration Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All Participants', 'description': 'Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.', 'interventionNames': ['Drug: Adriamycin®', 'Drug: Vinblastine', 'Drug: Nitrogen Mustard', 'Drug: Cyclophosphamide', 'Drug: Vincristine', 'Drug: Bleomycin', 'Drug: Etoposide', 'Drug: Prednisone', 'Biological: G-CSF', 'Procedure: Radiotherapy']}], 'interventions': [{'name': 'Adriamycin®', 'type': 'DRUG', 'otherNames': ['Doxorubicin'], 'description': 'Given IV on Day 1 of weeks 1, 3, 5, 7, 9 and 11.', 'armGroupLabels': ['All Participants']}, {'name': 'Vinblastine', 'type': 'DRUG', 'otherNames': ['Velban®'], 'description': 'Given IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11.', 'armGroupLabels': ['All Participants']}, {'name': 'Nitrogen Mustard', 'type': 'DRUG', 'otherNames': ['Mustargen®', 'Mechlorethamine Hydrochloride'], 'description': 'Given IV, Day 1 of weeks 1, 5 and 9. Cyclophosphamide may be substituted if nitrogen mustard is unavailable.', 'armGroupLabels': ['All Participants']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Nitrogen Mustard Derivative'], 'description': 'May be substituted if nitrogen mustard is unavailable. Given on Day 1 of weeks 1, 5 and 9.', 'armGroupLabels': ['All Participants']}, {'name': 'Vincristine', 'type': 'DRUG', 'otherNames': ['Velban®'], 'description': 'Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.', 'armGroupLabels': ['All Participants']}, {'name': 'Bleomycin', 'type': 'DRUG', 'otherNames': ['Blenoxane®'], 'description': 'Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.', 'armGroupLabels': ['All Participants']}, {'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['VP-16', 'Vepesid®'], 'description': 'Given IV on Days 1 and 2 of weeks 1-10.', 'armGroupLabels': ['All Participants']}, {'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['Synthetic congener of hydrocortisone'], 'description': 'Given PO every other day of weeks 1-12.', 'armGroupLabels': ['All Participants']}, {'name': 'G-CSF', 'type': 'BIOLOGICAL', 'otherNames': ['Filgrastim', 'Neupogen®'], 'description': 'Given subcutaneously days 3-13, 16-26, 29-39, 42-52, 55-65, and 68-78 (as clinically indicated).', 'armGroupLabels': ['All Participants']}, {'name': 'Radiotherapy', 'type': 'PROCEDURE', 'otherNames': ['Radiation therapy'], 'description': 'Participants receive radiotherapy after completion of 12 weeks of Stanford V chemotherapy.', 'armGroupLabels': ['All Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '04102-3175', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': "Maine Children's Medical Center", 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Jamie Flerlage, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}