Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
Study NCT ID:
NCT00145600
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2005-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Therapy for Pediatric Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@stjude.org', 'phone': '1-866-278-5833', 'title': 'Jamie Flerlage, MD', 'organization': "St. Jude Children's Research Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the date a patient went on study through the completion of therapy. The elapsed timeframe for adverse event collection was eleven years (March, 2000 through May, 2011).', 'eventGroups': [{'id': 'EG000', 'title': 'Favorable Risk', 'description': 'Ann Arbor stage IA or IIA with:\n\n1. Non-bulky mediastinal disease (\\<33% mediastinal to thoracic ratio on chest x-ray)\n2. \\< 3 nodal regions involved on the same side of the diaphragm\n3. No extranodal extension of disease', 'otherNumAtRisk': 88, 'otherNumAffected': 54, 'seriousNumAtRisk': 91, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intermediate Risk', 'description': 'Stage must be classified as one of the following:\n\n1. Ann Arbor stage IB and IIIA\n2. 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)', 'otherNumAtRisk': 46, 'otherNumAffected': 39, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Unfavorable Risk, Group 1', 'description': 'Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).', 'otherNumAtRisk': 13, 'otherNumAffected': 12, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Unfavorable Risk, Group 2', 'description': 'Stage must be classified as one of the following:\n\na. Ann Arbor stage IIB, IIIB, or any IV', 'otherNumAtRisk': 146, 'otherNumAffected': 116, 'seriousNumAtRisk': 146, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 85, 'numAffected': 52}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukocytes (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 51, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 42, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 236, 'numAffected': 89}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 66, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 118, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 98, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 51, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 234, 'numAffected': 101}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis/stomatitis (functional/symptomatic), Oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC<1.0x10e', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC, Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'AST, SGOT(serum glutamic oxaloacetic transaminase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bilirubin (hyperbilirubinemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Potassium, serum-low (hypokalemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event-free Survival Probability by Risk Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Favorable Risk', 'description': 'Ann Arbor stage IA or IIA with:\n\n1. Non-bulky mediastinal disease (\\<33% mediastinal to thoracic ratio on chest x-ray)\n2. \\< 3 nodal regions involved on the same side of the diaphragm\n3. No extranodal extension of disease'}, {'id': 'OG001', 'title': 'Intermediate Risk', 'description': 'Stage must be classified as one of the following:\n\n1. Ann Arbor stage IB and IIIA\n2. 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)'}, {'id': 'OG002', 'title': 'Unfavorable Risk, Group 1', 'description': 'Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).'}, {'id': 'OG003', 'title': 'Unfavorable Risk, Group 2', 'description': 'Stage must be classified as one of the following:\n\na. Ann Arbor stage IIB, IIIB, or any IV'}], 'classes': [{'categories': [{'measurements': [{'value': '0.886', 'groupId': 'OG000', 'lowerLimit': '0.820', 'upperLimit': '0.953'}, {'value': '0.844', 'groupId': 'OG001', 'lowerLimit': '0.739', 'upperLimit': '0.950'}, {'value': '0.667', 'groupId': 'OG002', 'lowerLimit': '0.400', 'upperLimit': '0.933'}, {'value': '0.793', 'groupId': 'OG003', 'lowerLimit': '0.726', 'upperLimit': '0.860'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'KM Event-free survival estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.886', 'ciLowerLimit': '0.820', 'ciUpperLimit': '0.953', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001'], 'paramType': 'KM event-free survival estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.844', 'ciLowerLimit': '0.739', 'ciUpperLimit': '0.950', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG002'], 'paramType': 'KM event-free survival estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.667', 'ciLowerLimit': '0.400', 'ciUpperLimit': '0.933', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG003'], 'paramType': 'KM event-free survival estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.793', 'ciLowerLimit': '0.726', 'ciUpperLimit': '0.860', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Median 6.4 year follow-up', 'description': "Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the Greenwood's formula.", 'unitOfMeasure': 'probability of 5 yr. event free survival', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Nine patients were ineligible for analysis.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}, {'value': '139', 'groupId': 'OG004'}, {'value': '139', 'groupId': 'OG005'}, {'value': '109', 'groupId': 'OG006'}, {'value': '109', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient At Diagnosis (T1)', 'description': 'Patients and parents were assessed for quality of life at Diagnosis (T1).'}, {'id': 'OG001', 'title': 'Parent At Diagnosis (T1)', 'description': 'Patients and parents were assessed for quality of life at Diagnosis (T1).'}, {'id': 'OG002', 'title': 'Patient Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG003', 'title': 'Parent Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG004', 'title': 'Patient Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG005', 'title': 'Parent Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG006', 'title': 'Patient 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}, {'id': 'OG007', 'title': 'Parent 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}], 'classes': [{'categories': [{'measurements': [{'value': '77.2', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '73.9', 'spread': '24.5', 'groupId': 'OG001'}, {'value': '72.3', 'spread': '20.2', 'groupId': 'OG002'}, {'value': '65.4', 'spread': '21.9', 'groupId': 'OG003'}, {'value': '74.7', 'spread': '20.9', 'groupId': 'OG004'}, {'value': '66.5', 'spread': '21', 'groupId': 'OG005'}, {'value': '84.5', 'spread': '16.6', 'groupId': 'OG006'}, {'value': '78.6', 'spread': '22.7', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.3097', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.60', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.50', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.37', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0197', 'groupIds': ['OG006', 'OG007'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG006', 'OG007'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.51', 'statisticalMethod': 'Spearman Correlation Coefficients', '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), and 3-6 months after the completion of therapy (T5).', 'description': 'Assess and compare the patient reported and parent proxy physical quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '146', 'groupId': 'OG003'}, {'value': '139', 'groupId': 'OG004'}, {'value': '139', 'groupId': 'OG005'}, {'value': '110', 'groupId': 'OG006'}, {'value': '110', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient At Diagnosis (T1)', 'description': 'Patients and parents were assessed for quality of life at Diagnosis (T1).'}, {'id': 'OG001', 'title': 'Parent At Diagnosis (T1)', 'description': 'Patients and parents were assessed for quality of life at Diagnosis (T1).'}, {'id': 'OG002', 'title': 'Patient Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG003', 'title': 'Parent Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG004', 'title': 'Patient Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG005', 'title': 'Parent Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG006', 'title': 'Patient 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}, {'id': 'OG007', 'title': 'Parent 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}], 'classes': [{'categories': [{'measurements': [{'value': '68.4', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '62.3', 'spread': '20.1', 'groupId': 'OG001'}, {'value': '70.7', 'spread': '20.5', 'groupId': 'OG002'}, {'value': '64', 'spread': '18.3', 'groupId': 'OG003'}, {'value': '74.1', 'spread': '20.4', 'groupId': 'OG004'}, {'value': '65.7', 'spread': '20.2', 'groupId': 'OG005'}, {'value': '78.5', 'spread': '21.3', 'groupId': 'OG006'}, {'value': '77.1', 'spread': '19.5', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.46', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.41', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.42', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3624', 'groupIds': ['OG006', 'OG007'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG006', 'OG007'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.52', 'statisticalMethod': 'Spearman Correlation Coefficients', '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), and 3-6 months after the completion of therapy (T5).', 'description': 'Assess and compare the patient reported and parent proxy emotional quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '138', 'groupId': 'OG004'}, {'value': '138', 'groupId': 'OG005'}, {'value': '110', 'groupId': 'OG006'}, {'value': '110', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient At Diagnosis (T1)', 'description': 'Patients and parents were assessed for quality of life at Diagnosis (T1).'}, {'id': 'OG001', 'title': 'Parent At Diagnosis (T1)', 'description': 'Patients and parents were assessed for quality of life at Diagnosis (T1).'}, {'id': 'OG002', 'title': 'Patient Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG003', 'title': 'Parent Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG004', 'title': 'Patient Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG005', 'title': 'Parent Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG006', 'title': 'Patient 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}, {'id': 'OG007', 'title': 'Parent 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}], 'classes': [{'categories': [{'measurements': [{'value': '87.2', 'spread': '16', 'groupId': 'OG000'}, {'value': '83', 'spread': '20.2', 'groupId': 'OG001'}, {'value': '87.2', 'spread': '14.5', 'groupId': 'OG002'}, {'value': '81.4', 'spread': '17.8', 'groupId': 'OG003'}, {'value': '88.2', 'spread': '12.9', 'groupId': 'OG004'}, {'value': '82.2', 'spread': '16.2', 'groupId': 'OG005'}, {'value': '91.5', 'spread': '13.2', 'groupId': 'OG006'}, {'value': '85.8', 'spread': '17.4', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.0254', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.44', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0004', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.32', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.39', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0014', 'groupIds': ['OG006', 'OG007'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0061', 'groupIds': ['OG006', 'OG007'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.26', 'statisticalMethod': 'Spearman Correlation Coefficients', '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), and 3-6 months after the completion of therapy (T5).', 'description': 'Assess and compare the patient reported and parent proxy social quality of life across multiple time points using the Peds Quality of Life version 4. 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We had some missing data and those over 18 years did not have parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}, {'value': '106', 'groupId': 'OG004'}, {'value': '106', 'groupId': 'OG005'}, {'value': '95', 'groupId': 'OG006'}, {'value': '95', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient At Diagnosis (T1)', 'description': 'Patients and parents were assessed for quality of life at Diagnosis (T1).'}, {'id': 'OG001', 'title': 'Parent At Diagnosis (T1)', 'description': 'Patients and parents were assessed for quality of life at Diagnosis (T1).'}, {'id': 'OG002', 'title': 'Patient Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG003', 'title': 'Parent Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG004', 'title': 'Patient Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG005', 'title': 'Parent Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG006', 'title': 'Patient 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}, {'id': 'OG007', 'title': 'Parent 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}], 'classes': [{'categories': [{'measurements': [{'value': '69.6', 'spread': '18', 'groupId': 'OG000'}, {'value': '66.2', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '67.2', 'spread': '20.6', 'groupId': 'OG002'}, {'value': '66.7', 'spread': '21.8', 'groupId': 'OG003'}, {'value': '69', 'spread': '21.6', 'groupId': 'OG004'}, {'value': '66.7', 'spread': '21.6', 'groupId': 'OG005'}, {'value': '78.6', 'spread': '18.3', 'groupId': 'OG006'}, {'value': '76.5', 'spread': '20', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.0687', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.65', 'statisticalMethod': 'Spearman Correlation Coefficient', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9478', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.42', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2999', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.49', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3121', 'groupIds': ['OG006', 'OG007'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG006', 'OG007'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.52', 'statisticalMethod': 'Spearman Correlation Coefficients', '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), and 3-6 months after the completion of therapy (T5).', 'description': 'Assess and compare the patient reported and parent proxy school quality of life across multiple time points using the Peds Quality of Life version 4. 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We had some missing data and those over 18 years did not have parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}, {'value': '106', 'groupId': 'OG004'}, {'value': '106', 'groupId': 'OG005'}, {'value': '95', 'groupId': 'OG006'}, {'value': '95', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient At Diagnosis (T1)', 'description': 'Patients and parents were assessed for quality of life at Diagnosis (T1).'}, {'id': 'OG001', 'title': 'Parent At Diagnosis (T1)', 'description': 'Patients and parents were assessed for quality of life at Diagnosis (T1).'}, {'id': 'OG002', 'title': 'Patient Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG003', 'title': 'Parent Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG004', 'title': 'Patient Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG005', 'title': 'Parent Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG006', 'title': 'Patient 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}, {'id': 'OG007', 'title': 'Parent 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}], 'classes': [{'categories': [{'measurements': [{'value': '75.7', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '71.3', 'spread': '16.4', 'groupId': 'OG001'}, {'value': '75.1', 'spread': '15', 'groupId': 'OG002'}, {'value': '71.1', 'spread': '15.3', 'groupId': 'OG003'}, {'value': '77.5', 'spread': '15.1', 'groupId': 'OG004'}, {'value': '72.3', 'spread': '15.9', 'groupId': 'OG005'}, {'value': '83.1', 'spread': '14.7', 'groupId': 'OG006'}, {'value': '80.7', 'spread': '15.9', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.0014', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.57', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0282', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0002', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.35', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0038', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.43', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1474', 'groupIds': ['OG006', 'OG007'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG006', 'OG007'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.49', 'statisticalMethod': 'Spearman Correlation Coefficients', '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), and 3-6 months after the completion of therapy (T5).', 'description': 'Assess and compare the patient reported and parent proxy psychosocial quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}, {'value': '106', 'groupId': 'OG004'}, {'value': '106', 'groupId': 'OG005'}, {'value': '94', 'groupId': 'OG006'}, {'value': '94', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient At Diagnosis (T1)', 'description': 'Patients and parents were assessed for quality of life at Diagnosis (T1).'}, {'id': 'OG001', 'title': 'Parent At Diagnosis (T1)', 'description': 'Patients and parents were assessed for quality of life at Diagnosis (T1).'}, {'id': 'OG002', 'title': 'Patient Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG003', 'title': 'Parent Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG004', 'title': 'Patient Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG005', 'title': 'Parent Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG006', 'title': 'Patient 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}, {'id': 'OG007', 'title': 'Parent 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}], 'classes': [{'categories': [{'measurements': [{'value': '76.2', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '72.4', 'spread': '17.7', 'groupId': 'OG001'}, {'value': '74.2', 'spread': '15.4', 'groupId': 'OG002'}, {'value': '69.3', 'spread': '16.2', 'groupId': 'OG003'}, {'value': '77', 'spread': '15.1', 'groupId': 'OG004'}, {'value': '70.6', 'spread': '16.1', 'groupId': 'OG005'}, {'value': '84', 'spread': '13.7', 'groupId': 'OG006'}, {'value': '80.7', 'spread': '16.2', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.0281', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.63', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0050', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.45', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0005', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.37', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0552', 'groupIds': ['OG006', 'OG007'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG006', 'OG007'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.54', 'statisticalMethod': 'Spearman Correlation Coefficients', '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), and 3-6 months after the completion of therapy (T5).', 'description': 'Assess and compare the patient reported and parent proxy Peds QL4 (composite) quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}, {'value': '106', 'groupId': 'OG004'}, {'value': '106', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG001', 'title': 'Parent Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG002', 'title': 'Patient Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG003', 'title': 'Parent Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG004', 'title': 'Patient 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}, {'id': 'OG005', 'title': 'Parent 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}], 'classes': [{'categories': [{'measurements': [{'value': '67.7', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '57.3', 'spread': '24.6', 'groupId': 'OG001'}, {'value': '69.4', 'spread': '26.4', 'groupId': 'OG002'}, {'value': '60.2', 'spread': '25.7', 'groupId': 'OG003'}, {'value': '83.4', 'spread': '23.4', 'groupId': 'OG004'}, {'value': '77', 'spread': '23.7', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.53', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxan signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.68', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0017', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.50', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).', 'description': 'Assess and compare the patient reported and parent proxy pain and hurt quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}, {'value': '101', 'groupId': 'OG004'}, {'value': '101', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG001', 'title': 'Parent Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG002', 'title': 'Patient Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG003', 'title': 'Parent Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG004', 'title': 'Patient 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}, {'id': 'OG005', 'title': 'Parent 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}], 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '58.6', 'spread': '22', 'groupId': 'OG001'}, {'value': '59.7', 'spread': '24.9', 'groupId': 'OG002'}, {'value': '57.7', 'spread': '23.8', 'groupId': 'OG003'}, {'value': '75', 'spread': '22.6', 'groupId': 'OG004'}, {'value': '78.9', 'spread': '22.9', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.2758', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.60', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1731', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.60', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0846', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.46', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy nausea quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '103', 'groupId': 'OG004'}, {'value': '103', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG001', 'title': 'Parent Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG002', 'title': 'Patient Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG003', 'title': 'Parent Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG004', 'title': 'Patient 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}, {'id': 'OG005', 'title': 'Parent 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}], 'classes': [{'categories': [{'measurements': [{'value': '71.3', 'spread': '27.9', 'groupId': 'OG000'}, {'value': '70.3', 'spread': '27.9', 'groupId': 'OG001'}, {'value': '73.8', 'spread': '27.7', 'groupId': 'OG002'}, {'value': '63.2', 'spread': '29.6', 'groupId': 'OG003'}, {'value': '78.5', 'spread': '25.4', 'groupId': 'OG004'}, {'value': '72.7', 'spread': '28.1', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.4263', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.51', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.54', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0468', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.55', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy procedural anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '130', 'groupId': 'OG003'}, {'value': '104', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG001', 'title': 'Parent Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG002', 'title': 'Patient Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG003', 'title': 'Parent Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG004', 'title': 'Patient 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}, {'id': 'OG005', 'title': 'Parent 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}], 'classes': [{'categories': [{'measurements': [{'value': '84.1', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '72.8', 'spread': '25.2', 'groupId': 'OG001'}, {'value': '82.8', 'spread': '22.7', 'groupId': 'OG002'}, {'value': '71.1', 'spread': '24.9', 'groupId': 'OG003'}, {'value': '82.1', 'spread': '23', 'groupId': 'OG004'}, {'value': '77.6', 'spread': '24.2', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.26', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0704', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.16', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0200', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.42', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy treatment anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}, {'value': '101', 'groupId': 'OG004'}, {'value': '101', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG001', 'title': 'Parent Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG002', 'title': 'Patient Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG003', 'title': 'Parent Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG004', 'title': 'Patient 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}, {'id': 'OG005', 'title': 'Parent 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}], 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '64.5', 'spread': '21.3', 'groupId': 'OG001'}, {'value': '64.7', 'spread': '24.9', 'groupId': 'OG002'}, {'value': '64.7', 'spread': '23.6', 'groupId': 'OG003'}, {'value': '67.1', 'spread': '28', 'groupId': 'OG004'}, {'value': '68.6', 'spread': '25.9', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.7192', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.42', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.8663', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.41', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7626', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.58', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy worry quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '126', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG001', 'title': 'Parent Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG002', 'title': 'Patient Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG003', 'title': 'Parent Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG004', 'title': 'Patient 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}, {'id': 'OG005', 'title': 'Parent 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}], 'classes': [{'categories': [{'measurements': [{'value': '77.6', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '75.7', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '78.9', 'spread': '20.2', 'groupId': 'OG002'}, {'value': '74.3', 'spread': '22.2', 'groupId': 'OG003'}, {'value': '80.8', 'spread': '20.4', 'groupId': 'OG004'}, {'value': '76.3', 'spread': '22.6', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.4807', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.36', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0824', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.39', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0496', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.50', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy cognitive problems (child + teen) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '126', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG001', 'title': 'Parent Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG002', 'title': 'Patient Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG003', 'title': 'Parent Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG004', 'title': 'Patient 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}, {'id': 'OG005', 'title': 'Parent 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}], 'classes': [{'categories': [{'measurements': [{'value': '77.5', 'spread': '23.1', 'groupId': 'OG000'}, {'value': '71.9', 'spread': '25.9', 'groupId': 'OG001'}, {'value': '77.6', 'spread': '23.3', 'groupId': 'OG002'}, {'value': '71.2', 'spread': '26.6', 'groupId': 'OG003'}, {'value': '78.4', 'spread': '25', 'groupId': 'OG004'}, {'value': '80.5', 'spread': '22.8', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0157', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.37', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0014', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.43', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1478', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.56', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy perceived physical appearance quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG001', 'title': 'Parent Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG002', 'title': 'Patient Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG003', 'title': 'Parent Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG004', 'title': 'Patient 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}, {'id': 'OG005', 'title': 'Parent 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}], 'classes': [{'categories': [{'measurements': [{'value': '78.3', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '73.6', 'spread': '27.8', 'groupId': 'OG001'}, {'value': '80.6', 'spread': '19.9', 'groupId': 'OG002'}, {'value': '74.9', 'spread': '25.2', 'groupId': 'OG003'}, {'value': '83.7', 'spread': '19.5', 'groupId': 'OG004'}, {'value': '83.1', 'spread': '20.6', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0831', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.25', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0135', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0024', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.27', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9848', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0974', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.16', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy communication quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.'}, {'type': 'SECONDARY', 'title': 'Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '91', 'groupId': 'OG004'}, {'value': '91', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG001', 'title': 'Parent Completion of 2 Cycles of Chemotherapy (T2)', 'description': 'Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).'}, {'id': 'OG002', 'title': 'Patient Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG003', 'title': 'Parent Completion of 4 Cycles of Chemotherapy (T3)', 'description': 'Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).'}, {'id': 'OG004', 'title': 'Patient 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}, {'id': 'OG005', 'title': 'Parent 3-6 Months After the Completion of Therapy (T5)', 'description': 'Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).'}], 'classes': [{'categories': [{'measurements': [{'value': '72.4', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '68.3', 'spread': '14.7', 'groupId': 'OG001'}, {'value': '72.7', 'spread': '16.7', 'groupId': 'OG002'}, {'value': '67.6', 'spread': '16.3', 'groupId': 'OG003'}, {'value': '78.1', 'spread': '16', 'groupId': 'OG004'}, {'value': '77.6', 'spread': '16', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0040', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.43', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0012', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.54', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.8108', 'groupIds': ['OG004', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Spearman Correlation Coefficients', 'ciPctValue': '95', 'paramValue': '0.55', 'statisticalMethod': 'Spearman Correlation Coefficients', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy PedsQL3 (composite) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Event-free Survival Probability by Risk Group at 10-year Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Favorable Risk', 'description': 'Ann Arbor stage IA or IIA with:\n\n1. Non-bulky mediastinal disease (\\<33% mediastinal to thoracic ratio on chest x-ray)\n2. \\< 3 nodal regions involved on the same side of the diaphragm\n3. No extranodal extension of disease'}, {'id': 'OG001', 'title': 'Intermediate Risk', 'description': 'Stage must be classified as one of the following:\n\n1. Ann Arbor stage IB and IIIA\n2. 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)'}, {'id': 'OG002', 'title': 'Unfavorable Risk, Group 1', 'description': 'Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).'}, {'id': 'OG003', 'title': 'Unfavorable Risk, Group 2', 'description': 'Stage must be classified as one of the following:\n\na. Ann Arbor stage IIB, IIIB, or any IV'}], 'classes': [{'categories': [{'measurements': [{'value': '0.874', 'groupId': 'OG000', 'lowerLimit': '0.805', 'upperLimit': '0.944'}, {'value': '0.844', 'groupId': 'OG001', 'lowerLimit': '0.739', 'upperLimit': '0.950'}, {'value': '0.667', 'groupId': 'OG002', 'lowerLimit': '0.400', 'upperLimit': '0.933'}, {'value': '0.785', 'groupId': 'OG003', 'lowerLimit': '0.716', 'upperLimit': '0.853'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'KM Event-free survival estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.874', 'ciLowerLimit': '0.805', 'ciUpperLimit': '0.944', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001'], 'paramType': 'KM event-free survival estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.844', 'ciLowerLimit': '0.739', 'ciUpperLimit': '0.950', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG002'], 'paramType': 'KM event-free survival estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.667', 'ciLowerLimit': '0.400', 'ciUpperLimit': '0.933', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG003'], 'paramType': 'KM event-free survival estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.785', 'ciLowerLimit': '0.716', 'ciUpperLimit': '0.853', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '10-year follow-up after protocol enrollment', 'description': "Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the with Greenwood's formula.", 'unitOfMeasure': 'probability 10 yr. event free survival', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Nine patients were ineligible for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Favorable Risk', 'description': 'Ann Arbor stage IA or IIA with:\n\n1. Non-bulky mediastinal disease (\\<33% mediastinal to thoracic ratio on chest x-ray)\n2. \\< 3 nodal regions involved on the same side of the diaphragm\n3. No extranodal extension of disease'}, {'id': 'FG001', 'title': 'Intermediate Risk', 'description': 'Stage must be classified as one of the following:\n\n1. Ann Arbor stage IB and IIIA\n2. 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)'}, {'id': 'FG002', 'title': 'Unfavorable Risk, Group 1', 'description': 'Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).'}, {'id': 'FG003', 'title': 'Unfavorable Risk, Group 2', 'description': 'Stage must be classified as one of the following:\n\na. Ann Arbor stage IIB, IIIB, or any IV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '146'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '130'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '296 patients were enrolled from 5 institutions between March 2000 and May 2011.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}, {'value': '296', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Favorable Risk', 'description': 'Ann Arbor stage IA or IIA with:\n\n1. Non-bulky mediastinal disease (\\<33% mediastinal to thoracic ratio on chest x-ray)\n2. \\< 3 nodal regions involved on the same side of the diaphragm\n3. No extranodal extension of disease'}, {'id': 'BG001', 'title': 'Intermediate Risk', 'description': 'Stage must be classified as one of the following:\n\n1. Ann Arbor stage IB and IIIA\n2. 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)'}, {'id': 'BG002', 'title': 'Unfavorable Risk, Group 1', 'description': 'Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).'}, {'id': 'BG003', 'title': 'Unfavorable Risk, Group 2', 'description': 'Stage must be classified as one of the following:\n\na. Ann Arbor stage IIB, IIIB, or any IV'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}, {'value': '253', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.08', 'spread': '3.91', 'groupId': 'BG000'}, {'value': '15.35', 'spread': '3.28', 'groupId': 'BG001'}, {'value': '14.85', 'spread': '3.21', 'groupId': 'BG002'}, {'value': '15.06', 'spread': '3.37', 'groupId': 'BG003'}, {'value': '14.48', 'spread': '3.63', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '153', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2005-09-02', 'resultsFirstSubmitDate': '2013-02-12', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-03-25', 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Event-free Survival Probability by Risk Group at 10-year Follow-Up', 'timeFrame': '10-year follow-up after protocol enrollment', 'description': "Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the with Greenwood's formula."}], 'primaryOutcomes': [{'measure': 'Event-free Survival Probability by Risk Group', 'timeFrame': 'Median 6.4 year follow-up', 'description': "Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the Greenwood's formula."}], 'secondaryOutcomes': [{'measure': 'Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points.', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).', 'description': 'Assess and compare the patient reported and parent proxy physical quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.'}, {'measure': 'Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points.', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).', 'description': 'Assess and compare the patient reported and parent proxy emotional quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.'}, {'measure': 'Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points.', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).', 'description': 'Assess and compare the patient reported and parent proxy social quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.'}, {'measure': 'Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points.', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).', 'description': 'Assess and compare the patient reported and parent proxy school quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.'}, {'measure': 'Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points.', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).', 'description': 'Assess and compare the patient reported and parent proxy psychosocial quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.'}, {'measure': 'Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points.', 'timeFrame': 'At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).', 'description': 'Assess and compare the patient reported and parent proxy Peds QL4 (composite) quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.'}, {'measure': 'Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points.', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).', 'description': 'Assess and compare the patient reported and parent proxy pain and hurt quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.'}, {'measure': 'Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points.', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy nausea quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.'}, {'measure': 'Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points.', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy procedural anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.'}, {'measure': 'Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points.', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy treatment anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.'}, {'measure': 'Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points.', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy worry quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.'}, {'measure': 'Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points.', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy cognitive problems (child + teen) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.'}, {'measure': 'Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points.', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy perceived physical appearance quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.'}, {'measure': 'Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points.', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy communication quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.'}, {'measure': 'Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points.', 'timeFrame': 'At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)', 'description': 'Assess and compare the patient reported and parent proxy PedsQL3 (composite) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphoma', 'Hodgkin Disease'], 'conditions': ['Hodgkin Lymphoma']}, 'referencesModule': {'references': [{'pmid': '22735430', 'type': 'DERIVED', 'citation': 'Metzger ML, Weinstein HJ, Hudson MM, Billett AL, Larsen EC, Friedmann A, Howard SC, Donaldson SS, Krasin MJ, Kun LE, Marcus KJ, Yock TI, Tarbell N, Billups CA, Wu J, Link MP. Association between radiotherapy vs no radiotherapy based on early response to VAMP chemotherapy and survival among children with favorable-risk Hodgkin lymphoma. JAMA. 2012 Jun 27;307(24):2609-16. doi: 10.1001/jama.2012.5847.'}], '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': "With the success of current chemotherapy for Hodgkin's disease, the goal of this protocol is to maintain the currently successful cure rate and reduce treatment related side effects and long term toxicity. The main purpose of this study is to estimate the event free survival of patients treated with risk-adapted therapy compared to historical controls.", 'detailedDescription': "This study will evaluate the following objectives:\n\nPrimary Objectives:\n\n1. To evaluate the efficacy of 4 cycles of VAMP chemotherapy alone in patients with favorable risk Hodgkin's disease who achieve a complete response after 2 cycles of VAMP chemotherapy.\n2. To evaluate the efficacy of 4 cycles VAMP chemotherapy plus low dose RT in patients with favorable risk Hodgkin's disease who achieve a partial response after 2 cycles of VAMP chemotherapy.\n3. To evaluate the efficacy of 2 alternating cycles of VAMP/COP chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field RT in children with intermediate risk Hodgkin's disease.\n4. To evaluate the efficacy of 12 weeks of Stanford V chemotherapy plus low-dose, involved-field RT in children with unfavorable risk Hodgkin's disease.\n\nSecondary Objectives:\n\n1. To evaluate patient quality of life during and after treatment from the patient and parent perspective.\n2. To compare patient and parental ratings of treatment-related symptoms and patient physical, psychological, social and cognitive functioning before the first treatment (T1 - baseline); after Cycle 2 or after 8 weeks of Stanford V (T2 - Evaluate Response); after cycle 4 or after 12 weeks of Stanford V and before or on the first day of radiation (as applicable) (T3); at the conclusion of radiation or within a few days following the end of radiation (as applicable) (T4); and at 3 to 6 months after completion of therapy follow-up evaluation (T5)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible patients must have histologically confirmed previously untreated Hodgkin\'s disease (Patients receiving limited emergent RT or steroid therapy because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment).\n* Patients must be 21 years of age or younger\n* Ann Arbor stages IIB-IV\n* No prior treatment.\n* No pregnant or lactating women.\n* Signed informed consent\n* If re-evaluation of a patient\'s disease shows favorable risk features or intermediate risk features, the patient will be removed from the HOD99 study and consented to the respective HOD08 or HOD05 study.\n\nInclusion: treatment of favorable risk features:\n\n* Ann Arbor IA or IIA with:\n\n 1. Non-bulky mediastinal disease (\\<33% mediastinal to thoracic ratio on chest x ray)\n 2. Ann Arbor stage IA or IIA with any of the following features: (1) "E" lesions (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\n Inclusion: unfavorable risk features:\n* Stage must be classified as one of the following:\n\n 1. Ann Arbor stage IIB, IIIB, or any IV'}, 'identificationModule': {'nctId': 'NCT00145600', 'briefTitle': 'Therapy for Pediatric Hodgkin Lymphoma', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': "Risk-Adapted Therapy for Pediatric Hodgkin's Disease", 'orgStudyIdInfo': {'id': 'HOD99'}, 'secondaryIdInfos': [{'id': 'NCI-2011-03721', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trial Registration Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unfavorable Risk, Group 2', 'description': "Unfavorable risk, group 2 arm in patients with Hodgkin's disease (n=146)", 'interventionNames': ['Drug: 12 Week Stanford V Chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Favorable Risk', 'description': "Favorable Risk arm in patients with Hodgkin's Disease (n=91).", 'interventionNames': ['Drug: 4 cycles of VAMP chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Intermediate Risk', 'description': "Intermediate Arm in patients with Hodgkins's disease (n=46).", 'interventionNames': ['Drug: 2 alternating cycles of VAMP/COP chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Unfavorable Risk, Group 1', 'description': 'Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).', 'interventionNames': ['Drug: 3 alternating cycles of VAMP/COP chemotherapy']}], 'interventions': [{'name': '12 Week Stanford V Chemotherapy', 'type': 'DRUG', 'description': '12 weeks of Stanford V chemotherapy plus low-dose, involved-field RT in children', 'armGroupLabels': ['Unfavorable Risk, Group 2']}, {'name': '4 cycles of VAMP chemotherapy', 'type': 'DRUG', 'description': '4 cycles of VAMP chemotherapy alone in patients who achieve a complete response after 2 cycles of VAMP chemotherapy. For patients that do not achieve a complete response after 2 cycles of VAMP, they will receive low low-dose involved field radiotherapy at the end of all chemotherapy.', 'armGroupLabels': ['Favorable Risk']}, {'name': '2 alternating cycles of VAMP/COP chemotherapy', 'type': 'DRUG', 'description': '2 alternating cycles of VAMP/COP chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field RT.', 'armGroupLabels': ['Intermediate Risk']}, {'name': '3 alternating cycles of VAMP/COP chemotherapy', 'type': 'DRUG', 'description': '3 alternating cycles of VAMP/COP chemotherapy (total 6 cycles of chemotherapy) plus low-dose, involved-field RT', 'armGroupLabels': ['Unfavorable Risk, Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '04102-3175', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': "Maine Children's Cancer Program", 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', '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'}}}}