Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT00924651
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2009-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Karen_Mustian@urmc.rochester.edu', 'phone': '585-273-1796', 'title': 'Karen M. Mustian, PhD, MPH, Associate Professor', 'organization': 'University of Rochester Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard Care + EXCAP', 'description': 'Personalized exercise prescription\n\nexercise: home based walking and progressive resistance training exercise', 'otherNumAtRisk': 331, 'otherNumAffected': 2, 'seriousNumAtRisk': 331, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Standard Care', 'description': 'Wait list control', 'otherNumAtRisk': 312, 'otherNumAffected': 3, 'seriousNumAtRisk': 312, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Failure to thrive (dehydra, hypokalemia, anorexia, diarrhea, fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Abdominal pain/acute typhilitis w/ neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Questionable thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Neutropenic fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}], 'seriousEvents': [{'term': 'Lymphopenia, gr 4 leukocytes & neutrophils', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Multi organ failure & susbsequent death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Neutropenia & possible port infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Neutropenia, cough, fever, fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 331, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Cancer-related Fatigue as Assessed by the Brief Fatigue Inventory (BFI) Total Score at Day 41 (After Exercise Intervention) Minus BFI Total Score at Day 0 (Before Exercise Intervention)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care + EXCAP', 'description': 'Personalized exercise prescription\n\nexercise: home based walking and progressive resistance training exercise'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Wait list control'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9148', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01916', 'ciLowerLimit': '-0.3710', 'ciUpperLimit': '0.3327', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1791', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '41 days: Day 0 (before intervention) Day 41 (post intervention)', 'description': 'BFI has nine items. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient\'s life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes." BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue).\n\nThe outcome measure is the change in the Brief Fatigue Inventory Total Score at day 41 (after exercise intervention) minus Brief Fatigue Inventory Total Score at day 0 (before exercise intervention).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects completing both BFI at day 0 and day 41'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Care + EXCAP', 'description': 'Personalized exercise prescription\n\nexercise: home based walking and progressive resistance training exercise'}, {'id': 'FG001', 'title': 'Standard Care', 'description': 'Wait list control'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '356'}, {'groupId': 'FG001', 'numSubjects': '337'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '331'}, {'groupId': 'FG001', 'numSubjects': '312'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Chemo started too soon', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'No Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Overwhelmed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Noncompliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Medical', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Changed Mind', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Incomplete Form', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '643', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Care + EXCAP', 'description': 'Personalized exercise prescription\n\nexercise: home based walking and progressive resistance training exercise'}, {'id': 'BG001', 'title': 'Standard Care', 'description': 'Wait list control'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '56.4', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '56.8', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '306', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '604', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity, Customized', 'categories': [{'title': 'White', 'measurements': [{'value': '285', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '30.1', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '30.2', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '30.1', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: Body Mass Index (BMI) is a person\'s weight in kilograms divided by the square of height in meters. Values below 18.5 represent "Underweight", 18.5 to 24.9 represent "Normal or Healthy Weight", 25.0 to 29.9 represent "Overweight" and 30.0 and above represent "Obese".', 'unitOfMeasure': 'kg / m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Currently Employed', 'classes': [{'categories': [{'title': 'Employed outside the house', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '368', 'groupId': 'BG002'}]}, {'title': 'Self-Employed', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Home-Maker with >= 1 dependents', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Unemployed', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital Status', 'classes': [{'categories': [{'title': 'Married or long-term committed relationship', 'measurements': [{'value': '236', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}, {'title': 'Divorced or separated', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Single', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Widowed', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'Graduate degree', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': '2 or 4 degree or Some college', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}, {'title': 'High school / GED degree', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': 'No high school or GED degree', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer Type', 'classes': [{'categories': [{'title': 'Breast', 'measurements': [{'value': '271', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}, {'title': 'Lymphoma', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Colon', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Lung', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer Stage', 'classes': [{'categories': [{'title': 'Stage I', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'Stage II', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}, {'title': 'Stage III', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}, {'title': 'Stage IV', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Stage I.This stage is usually a small cancer or tumor that has not grown deeply into nearby tissues. It also has not spread to the lymph nodes or other parts of the body.\n\nStage II and III.These stages indicate larger cancers or tumors that have grown more deeply into nearby tissue. They may have also spread to lymph nodes but not other parts of the body.\n\nStage IV.This stage means that the cancer has spread to other organs or parts of the body. It may also be called metastatic cancer.\n\nUnknown Stage. There is not enough information to determine stage.\n\nStage I is best, Stage IV is worst.', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Treatment - Surgery', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '296', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '571', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Treatment - Chemotherapy', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '329', 'groupId': 'BG000'}, {'value': '308', 'groupId': 'BG001'}, {'value': '637', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Treatment - Radiation Therapy', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '323', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '629', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Treatment - Hormone Therapy', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '318', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '622', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time since end of first cancer treatment, weeks', 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'spread': '72.9', 'groupId': 'BG000'}, {'value': '6.8', 'spread': '23.7', 'groupId': 'BG001'}, {'value': '10.8', 'spread': '55.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Karnofsky Performance Status (KPS)', 'classes': [{'categories': [{'measurements': [{'value': '94.2', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '94.8', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '94.5', 'spread': '7.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: The Karnofsky Performance Scale (KPS) Index allows patients to be classified as to their functional impairment. Essentially as used in oncology, the KPS is a measure of time to death. A higher score is favorable. There are 3 general categories which are broken down into 11 specific criteria. Scale range is from 0 (Dead) to 100 (Normal, no complaints, no evidence of disease). The scale increases in units of 10.', 'unitOfMeasure': 'Karnofsky Performance Scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Exercise Stages of Change', 'classes': [{'categories': [{'title': "Not exercising and don't intend to in next 6 month", 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Not exercising but do intend to in next 6 months', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}, {'title': 'Not exercising but intend to in next 30 days', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}]}, {'title': 'Exercising and have been for less than 6 months', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Exercising and have been for more than 6 months', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 693}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2009-06-18', 'resultsFirstSubmitDate': '2017-02-23', 'studyFirstSubmitQcDate': '2009-06-18', 'lastUpdatePostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-05', 'studyFirstPostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Cancer-related Fatigue as Assessed by the Brief Fatigue Inventory (BFI) Total Score at Day 41 (After Exercise Intervention) Minus BFI Total Score at Day 0 (Before Exercise Intervention)', 'timeFrame': '41 days: Day 0 (before intervention) Day 41 (post intervention)', 'description': 'BFI has nine items. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient\'s life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes." BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue).\n\nThe outcome measure is the change in the Brief Fatigue Inventory Total Score at day 41 (after exercise intervention) minus Brief Fatigue Inventory Total Score at day 0 (before exercise intervention).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fatigue', 'unspecified adult solid tumor, protocol specific'], 'conditions': ['Fatigue', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '34191201', 'type': 'DERIVED', 'citation': 'Kleckner IR, Jusko TA, Culakova E, Chung K, Kleckner AS, Asare M, Inglis JE, Loh KP, Peppone LJ, Miller J, Melnik M, Kasbari S, Ossip D, Mustian KM. Longitudinal study of inflammatory, behavioral, clinical, and psychosocial risk factors for chemotherapy-induced peripheral neuropathy. Breast Cancer Res Treat. 2021 Sep;189(2):521-532. doi: 10.1007/s10549-021-06304-6. Epub 2021 Jun 30.'}, {'pmid': '30937600', 'type': 'DERIVED', 'citation': 'Kleckner IR, Kamen C, Cole C, Fung C, Heckler CE, Guido JJ, Culakova E, Onitilo AA, Conlin A, Kuebler JP, Mohile S, Janelsins M, Mustian KM. Effects of exercise on inflammation in patients receiving chemotherapy: a nationwide NCORP randomized clinical trial. Support Care Cancer. 2019 Dec;27(12):4615-4625. doi: 10.1007/s00520-019-04772-7. Epub 2019 Apr 2.'}, {'pmid': '29243164', 'type': 'DERIVED', 'citation': 'Kleckner IR, Kamen C, Gewandter JS, Mohile NA, Heckler CE, Culakova E, Fung C, Janelsins MC, Asare M, Lin PJ, Reddy PS, Giguere J, Berenberg J, Kesler SR, Mustian KM. Effects of exercise during chemotherapy on chemotherapy-induced peripheral neuropathy: a multicenter, randomized controlled trial. Support Care Cancer. 2018 Apr;26(4):1019-1028. doi: 10.1007/s00520-017-4013-0. Epub 2017 Dec 14.'}], 'seeAlsoLinks': [{'url': 'https://www.cancer.gov/publications/pdq', 'label': "Clinical trial summary from the National Cancer Institute's PDQ® database"}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Physical activity may help lessen fatigue caused by cancer in patients receiving chemotherapy. It is not yet known whether a home-based walking and resistance-band exercise program is effective in lessening fatigue.\n\nPURPOSE: This randomized phase III trial is studying how well exercise works in lessening fatigue caused by cancer in patients undergoing chemotherapy.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the efficacy of a home-based walking and progressive-resistance exercise program in reducing cancer-related fatigue (CRF) in patients undergoing chemotherapy.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to participating site, chemotherapy course length (2 weeks vs 3 weeks), gender, and degree of fatigue reported on the study assessment questionnaire (≤ 5 vs \\> 5). Patients are randomized to 1 of 2 intervention arms.\n\n* Arm I: Patients receive standard chemotherapy.\n* Arm II: Patients receive a home-based walking kit comprising an Exercise for Cancer Patients Manual, a pedometer, and therapeutic resistance bands. Patients undergo moderately intense aerobic exercise (walking) monitored by a pedometer, and low to moderately intense progressive-resistance exercise using therapeutic resistance bands for 6 weeks. Patients also receive standard chemotherapy.\n\nPatients in both arms undergo assessment of their aerobic capacity and strength by the 6-minute walk test and handgrip dynamometry at baseline and at day 41. They also have a fasting blood draw and wear an actigraph for one week at baseline and week 6. Patients complete Functional Assessment of Chronic Illness Therapy-Fatigue and -Cognitive Subscales, Brief Fatigue Inventory, Multidimensional Fatigue Symptom Inventory, Center for Epidemiological Studies-Depression Scale State Trait Anxiety Inventory, Pittsburgh Sleep Quality Inventory, Profile of Mood States, Aerobic Center Longitudinal Study Physical Activity, and Symptom Inventory questionnaires at baseline and at day 41 and keep a daily exercise diary during study intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* primary diagnosis of cancer other than leukemia, with no distant metastasis\n* chemotherapy naïve\n* starting chemotherapy treatments for cancer and scheduled for at least 6 weeks of treatments with treatment cycles of either 2, 3 or 4 weeks. Oral chemotherapy (e.g., Xeloda) is acceptable\n* Karnofsky Performance level of 70 or greater\n* able to read English\n\nExclusion criteria:\n\n* diagnosis of leukemia\n* metastatic disease\n* receiving concurrent radiation therapy\n* physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking and progressive resistance program\n* identified as in the active or maintenance stage of exercise behavior as assessed by the Exercise Stages of Change Short Form'}, 'identificationModule': {'nctId': 'NCT00924651', 'acronym': 'EXCAP', 'briefTitle': 'Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'A Study of the Effects of Exercise on Cancer-Related Fatigue', 'orgStudyIdInfo': {'id': 'UCCO08106; URCC0701'}, 'secondaryIdInfos': [{'id': 'U10CA037420', 'link': 'https://reporter.nih.gov/quickSearch/U10CA037420', 'type': 'NIH'}, {'id': 'UCCO-08106', 'type': 'OTHER', 'domain': 'URCC'}, {'id': 'URCC 0701', 'type': 'OTHER_GRANT', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard Care + EXCAP', 'description': 'Personalized exercise prescription', 'interventionNames': ['Behavioral: exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Wait list control'}], 'interventions': [{'name': 'exercise', 'type': 'BEHAVIORAL', 'otherNames': ['EXCAP'], 'description': 'home based walking and progressive resistance training exercise', 'armGroupLabels': ['Standard Care + EXCAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'James P. Wilmot Cancer Center at University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Karen M. Mustian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gary Morrow', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gary Morrow', 'investigatorAffiliation': 'University of Rochester'}}}}