Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT00293293
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2006-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014110', 'term': 'Touch'}, {'id': 'D008405', 'term': 'Massage'}, {'id': 'D006990', 'term': 'Hypnosis'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'C080625', 'term': 'taxane'}, {'id': 'D010984', 'term': 'Platinum'}], 'ancestors': [{'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Patricia.Judson@moffitt.org', 'phone': '813-745-1600', 'title': 'Patricia L. Judson, M.D.', 'organization': 'Moffitt Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From 1st Treatment through 30 Days Post Chemotherapy (approximately 7 months)', 'description': 'Only Serious Adverse Events were collected in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Chemotherapy Alone', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Chemotherapy + CAM', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Sexual/Reproductive Function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection/Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Alone', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.'}, {'id': 'OG001', 'title': 'Chemotherapy + CAM', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).'}], 'classes': [{'title': 'Prior to Cycle 1', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000', 'lowerLimit': '121', 'upperLimit': '200'}, {'value': '152', 'groupId': 'OG001', 'lowerLimit': '138', 'upperLimit': '187'}]}]}, {'title': 'Prior to Cycle 3', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000', 'lowerLimit': '120', 'upperLimit': '179'}, {'value': '152', 'groupId': 'OG001', 'lowerLimit': '101', 'upperLimit': '184'}]}]}, {'title': 'Prior to Cycle 6', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000', 'lowerLimit': '141', 'upperLimit': '188'}, {'value': '152', 'groupId': 'OG001', 'lowerLimit': '119', 'upperLimit': '200'}]}]}, {'title': '6 Months Post Chemotherapy (+/- 15 days)', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '190'}, {'value': '162', 'groupId': 'OG001', 'lowerLimit': '155', 'upperLimit': '200'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy', 'description': "Measured by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire was used to assess patients' quality of life before each chemotherapy cycle. It is a standardized self-administered questionnaire measuring many aspects of quality of life (0 to 4; Not at all, A little bit, Some-what, Quite a bit, Very much) as related to patients with ovarian cancers. The quality of life measures include the total FACT-O score (minimum value 0, maximum value 200). Questionnaires are recoded in the final analysis phase so that a higher score reflected more adverse effects on quality of life.", 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-10'}, {'type': 'PRIMARY', 'title': 'Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Alone', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.'}, {'id': 'OG001', 'title': 'Chemotherapy + CAM', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).'}], 'classes': [{'title': 'Prior to Cycle 1', 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000', 'lowerLimit': '141', 'upperLimit': '209'}, {'value': '191', 'groupId': 'OG001', 'lowerLimit': '165', 'upperLimit': '230'}]}]}, {'title': 'Prior to Cycle 3', 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000', 'lowerLimit': '120', 'upperLimit': '228'}, {'value': '189', 'groupId': 'OG001', 'lowerLimit': '145', 'upperLimit': '213'}]}]}, {'title': 'Prior to Cycle 6', 'categories': [{'measurements': [{'value': '196', 'groupId': 'OG000', 'lowerLimit': '141', 'upperLimit': '222'}, {'value': '197', 'groupId': 'OG001', 'lowerLimit': '166', 'upperLimit': '230'}]}]}, {'title': '6 Months Post Chemotherapy (+/- 15 days)', 'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000', 'lowerLimit': '129', 'upperLimit': '203'}, {'value': '187', 'groupId': 'OG001', 'lowerLimit': '179', 'upperLimit': '233'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy', 'description': "The MHI asks questions about how the consumer is feeling and coping with usual life activities. It provides measurable information about the consumer's wellbeing (anxiety, depression, loss of emotional control, general positive affect and emotional ties). A single score based on all items designed as high level summary index of the person's mental health status. High scores on the Mental Health Index indicate greater psychological well being and relatively less psychological distress (range is 38-240).", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Delays In Receiving Chemotherapy Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Alone', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Number of patients who had to delay their chemotherapy treatments due to side effects.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Delays In Receiving Chemotherapy Plus CAM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Plus CAM', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Number of patients who had to delay their chemotherapy treatments and or complementary alternative medicine due to side effects.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Alone', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.75', 'spread': '0.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Determined by averaging the total number of anti-emetic prescriptions given per patient after receiving chemotherapy.', 'unitOfMeasure': 'Prescriptions per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients that received 6 cycles of chemotherapy alone.'}, {'type': 'SECONDARY', 'title': 'Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Plus CAM', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.95', 'spread': '0.81', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Determined by averaging the total number of anti-emetic prescriptions given per patient after chemotherapy and complementary alternative medicine.', 'unitOfMeasure': 'Prescriptions per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).'}, {'type': 'SECONDARY', 'title': 'Average Anti-Emetic Dose Use After Chemotherapy Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Alone', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '453.2', 'spread': '91.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient.', 'unitOfMeasure': 'Dose (mg) per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Anti-Emetic Dose Use After Chemotherapy Plus CAM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Plus CAM', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '604.2', 'spread': '95.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient after receiving chemotherapy and complementary alternative medicine.', 'unitOfMeasure': 'Dose (mg) per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Natural Killer Cell Count Levels Before Chemotherapy Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Alone', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000', 'lowerLimit': '141.3', 'upperLimit': '257.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm\\^3 drawn before chemotherapy) using flow cytometry and specific mAb.', 'unitOfMeasure': 'Cells per mm^3', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Natural Killer Cell Count Levels Before Chemotherapy and CAM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Plus CAM', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '244', 'groupId': 'OG000', 'lowerLimit': '202.6', 'upperLimit': '314.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm\\^3 drawn before chemotherapy) using flow cytometry and specific mAb.', 'unitOfMeasure': 'Cells per mm^3', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Alone', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.'}, {'id': 'OG001', 'title': 'Chemotherapy + CAM', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Number of patients that had infections requiring antibiotic therapy or admission to the hospital that received either chemotherapy alone or chemotherapy plus complementary alternative medicine.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Alone', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.'}, {'id': 'OG001', 'title': 'Chemotherapy + CAM', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Count of patients who were admitted to the hospital after receiving chemotherapy treatment or chemotherapy plus complementary alternative medicine.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Alone', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.'}, {'id': 'OG001', 'title': 'Chemotherapy + CAM', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '5653', 'spread': '695.4', 'groupId': 'OG000'}, {'value': '6144', 'spread': '839.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months)', 'description': 'Determined from white blood cell counts collected during treatment phase of study; average applied.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Alone', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.'}, {'id': 'OG001', 'title': 'Chemotherapy + CAM', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).'}], 'classes': [{'title': 'CD4', 'categories': [{'measurements': [{'value': '680', 'spread': '58.0', 'groupId': 'OG000'}, {'value': '811', 'spread': '82.6', 'groupId': 'OG001'}]}]}, {'title': 'CD8', 'categories': [{'measurements': [{'value': '281', 'spread': '30.4', 'groupId': 'OG000'}, {'value': '364', 'spread': '34.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Average count determined - collected during treatment phase of study - Includes T-helper/inducer, CD4 and CD8 cells; number of CD4 and CD8 cells (in mm\\^3).', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy Alone', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.'}, {'id': 'OG001', 'title': 'Chemotherapy + CAM', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '14.07', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '8.66', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Determined from collection of saliva during treatment phase of study and recorded in mg/dL units.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-10'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chemotherapy Alone', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.'}, {'id': 'FG001', 'title': 'Chemotherapy + CAM', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Patient "too anxious" to complete trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient discontinued chemotherapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Eligible patients made informed consent and were randomized to chemotherapy alone or chemotherapy with complementary alternative medicine (hypnosis, massage, healing touch). Patients received either intravenous paclitaxel and carboplatin on an every 3 week basis, or a combination of intravenous and intraperitoneal paclitaxel and cisplatin.', 'preAssignmentDetails': 'Analysis was conducted as intent-to-treat. All randomized patients were included, regardless of number of courses of chemotherapy, CAM therapy or survival. All women in the CAM arm of the trial received all prescribed CAM interventions. No investigational drugs were administered as a part of this protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Chemotherapy Alone', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.'}, {'id': 'BG001', 'title': 'Chemotherapy + CAM', 'description': 'Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '58.8', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '60.72', 'spread': '11.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-03', 'studyFirstSubmitDate': '2006-02-16', 'resultsFirstSubmitDate': '2011-08-22', 'studyFirstSubmitQcDate': '2006-02-16', 'lastUpdatePostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-05-02', 'studyFirstPostDateStruct': {'date': '2006-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)', 'timeFrame': 'Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy', 'description': "Measured by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire was used to assess patients' quality of life before each chemotherapy cycle. It is a standardized self-administered questionnaire measuring many aspects of quality of life (0 to 4; Not at all, A little bit, Some-what, Quite a bit, Very much) as related to patients with ovarian cancers. The quality of life measures include the total FACT-O score (minimum value 0, maximum value 200). Questionnaires are recoded in the final analysis phase so that a higher score reflected more adverse effects on quality of life."}, {'measure': 'Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM', 'timeFrame': 'Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy', 'description': "The MHI asks questions about how the consumer is feeling and coping with usual life activities. It provides measurable information about the consumer's wellbeing (anxiety, depression, loss of emotional control, general positive affect and emotional ties). A single score based on all items designed as high level summary index of the person's mental health status. High scores on the Mental Health Index indicate greater psychological well being and relatively less psychological distress (range is 38-240)."}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Delays In Receiving Chemotherapy Alone', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Number of patients who had to delay their chemotherapy treatments due to side effects.'}, {'measure': 'Number of Patients With Delays In Receiving Chemotherapy Plus CAM', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Number of patients who had to delay their chemotherapy treatments and or complementary alternative medicine due to side effects.'}, {'measure': 'Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Determined by averaging the total number of anti-emetic prescriptions given per patient after receiving chemotherapy.'}, {'measure': 'Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Determined by averaging the total number of anti-emetic prescriptions given per patient after chemotherapy and complementary alternative medicine.'}, {'measure': 'Average Anti-Emetic Dose Use After Chemotherapy Alone', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient.'}, {'measure': 'Average Anti-Emetic Dose Use After Chemotherapy Plus CAM', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient after receiving chemotherapy and complementary alternative medicine.'}, {'measure': 'Average Natural Killer Cell Count Levels Before Chemotherapy Alone', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm\\^3 drawn before chemotherapy) using flow cytometry and specific mAb.'}, {'measure': 'Average Natural Killer Cell Count Levels Before Chemotherapy and CAM', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm\\^3 drawn before chemotherapy) using flow cytometry and specific mAb.'}, {'measure': 'Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Number of patients that had infections requiring antibiotic therapy or admission to the hospital that received either chemotherapy alone or chemotherapy plus complementary alternative medicine.'}, {'measure': 'Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Count of patients who were admitted to the hospital after receiving chemotherapy treatment or chemotherapy plus complementary alternative medicine.'}, {'measure': 'Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM', 'timeFrame': 'Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months)', 'description': 'Determined from white blood cell counts collected during treatment phase of study; average applied.'}, {'measure': 'Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Average count determined - collected during treatment phase of study - Includes T-helper/inducer, CD4 and CD8 cells; number of CD4 and CD8 cells (in mm\\^3).'}, {'measure': 'Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM', 'timeFrame': 'Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)', 'description': 'Determined from collection of saliva during treatment phase of study and recorded in mg/dL units.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage I ovarian epithelial cancer', 'stage II ovarian epithelial cancer', 'stage III ovarian epithelial cancer', 'stage IV ovarian epithelial cancer', 'peritoneal cavity cancer'], 'conditions': ['Ovarian Cancer', 'Peritoneal Primary Cancer', 'Fallopian Tube Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hypnosis, massage therapy, and healing touch may improve the quality of life of patients who are undergoing chemotherapy.\n\nPURPOSE: This randomized clinical trial is studying how well giving hypnosis, massage therapy and healing touch changes outcomes in women receiving chemotherapy for newly diagnosed epithelial ovarian, fallopian tube or peritoneal cavity cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine whether quality of life is improved in patients with epithelial ovarian, fallopian tube or primary peritoneal cavity cancer receiving hypnosis, massage therapy, and healing touch and standard chemotherapy as compared to patients receiving standard chemotherapy alone.\n\nSecondary\n\n* Determine changes in immunologic response markers, chemotherapy side effects, and complication rates in these patients.\n\nOUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I (standard therapy): Patients undergo standard chemotherapy for epithelial ovarian, fallopian tube or primary peritoneal cancer.\n* Arm II (standard therapy with complementary alternative medicine): Patients undergo chemotherapy as in arm I. Patients also undergo massage over approximately 30 minutes and healing touch therapy over approximately 30 minutes with each course of chemotherapy 1-6 and hypnosis over 30-60 minutes during courses 1, 2, and 4.\n\nQuality of life is assessed at baseline, during courses 3 and 6 of chemotherapy, and then 6 months after completion of study treatment.\n\nAfter completion of study treatment, patients are followed at 6 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer, any pathologic type or stage, who will receive 6 cycles of chemotherapy.\n* Patients must have signed an informed consent\n\nExclusion Criteria:\n\n* Previous cancer other than skin cancer\n* Previous chemotherapy experience\n* Active substance abuse\n* Schizophrenia\n* Pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT00293293', 'briefTitle': 'Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine', 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'officialTitle': 'Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine', 'orgStudyIdInfo': {'id': '2000NT790'}, 'secondaryIdInfos': [{'id': 'UMN-WCC-30', 'type': 'OTHER', 'domain': "Women's Cancer Center, University of Minnesota"}, {'id': '0012M77821', 'type': 'OTHER', 'domain': 'IRB, University of Minnesota'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapy Alone', 'description': 'Patients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or primary peritoneal cancer by their treating physician. Chemotherapy administration is not administered as part of this protocol.', 'interventionNames': ['Drug: Standard chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Chemotherapy + CAM', 'description': 'Patients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or peritoneal cancer with additional complementary alternative medicine - CAM (healing touch, hypnosis and massage therapy). Chemotherapy administration is not administered as part of this protocol.', 'interventionNames': ['Other: healing touch', 'Other: massage therapy', 'Other: hypnosis']}], 'interventions': [{'name': 'healing touch', 'type': 'OTHER', 'otherNames': ['energy-based therapy'], 'description': 'The practitioner performed a structured interview with the patient both a verbal assessment and an energy/physical assessment using pendulum and hand scan techniques. The practitioner will then provide the intervention which will consist of: chakra connection, magnetic passes (hands still and in motion), magnetic clearing.', 'armGroupLabels': ['Standard Chemotherapy + CAM']}, {'name': 'massage therapy', 'type': 'OTHER', 'otherNames': ['massage'], 'description': "Standard massage techniques will be employed over the head, neck, shoulders, back, hands, and/or feet areas. The intensity and rapidity of massage movements will be individualized to the patient's comfort level.", 'armGroupLabels': ['Standard Chemotherapy + CAM']}, {'name': 'hypnosis', 'type': 'OTHER', 'otherNames': ['mind-body intervention procedure'], 'description': 'Steps: 1) begins with a progressive relaxation induction; 2) suggestions for deepening are then provided; 3) offered suggestions to increase comfort with medical procedures; 4) suggestion for enhanced capacity for coping will be given as an ego strengthening suggestion, with a post-hypnotic suggestion for increasing comfort/success in coping each time.', 'armGroupLabels': ['Standard Chemotherapy + CAM']}, {'name': 'Standard chemotherapy', 'type': 'DRUG', 'otherNames': ['Taxane', 'Platinum'], 'description': 'Patients will receive 6 cycles of taxane and platinum therapy as prescribed by their treating physician. Chemotherapy treatment is not part of this study.', 'armGroupLabels': ['Chemotherapy Alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Masonic Cancer Center at University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Patricia L. Judson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Moffitt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Randy Shaver Cancer Research Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}