Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-21 @ 3:02 PM
Study NCT ID:
NCT01990066
Status:
TERMINATED
Last Update Posted:
2014-12-24
First Post:
2013-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home Based Exercise Program for Elderly Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Difficulty recruiting adequate enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-23', 'studyFirstSubmitDate': '2013-11-15', 'studyFirstSubmitQcDate': '2013-11-20', 'lastUpdatePostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Cancer Related Fatigue (CRF)', 'timeFrame': 'Baseline, +/- 7days of 4th chemo cycle (mid point), +/- 7 days of 3 weeks after 6th cycle (end point)', 'description': 'CRF will be evaluated using the FACIT-F tool.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Improvement (QOL)', 'timeFrame': 'Baseline, +/- 7days of cycle 4 of treatment (mid point), +/- 7 days of 3rd week after cycle 6 (end point)', 'description': 'QOL will be evaluated using the NHANES and FACIT-F tools.'}, {'measure': 'Reduction in Physical Functional Decline', 'timeFrame': 'Baseline and +/- 7days of 3 weeks post 6th cycle (end point)', 'description': 'Physical function will be evaluated using the Berg Balance Test and 6 Min Walk Test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Quality of Life', 'Physical Function'], 'conditions': ['Cancer Related Fatigue']}, 'descriptionModule': {'briefSummary': 'Implementation of a home based exercise program to reduce functional decline, cancer related fatigue (CRF) and improve quality of life in the elderly gynecologic oncology patient\n\nProblem:\n\nCan prevention of CRF and loss of function improve QOL in the elderly gynecologic oncology patient undergoing chemotherapy?\n\nSupport:\n\nFatigue and its impact on QOL is a major concern with the elderly patient receiving chemotherapy. When compared to younger adults QOL is more important than gain in survival for elderly patients. (Eyigor, et al., 2010).\n\nThe National Comprehensive Cancer Network recommends exercise as the most effective intervention for cancer related fatigue.\n\nMethods:\n\nThis is a single institution randomized controlled study to evaluate a home based exercise program in elderly gynecologic oncology patients undergoing chemotherapy. Subjects will be randomized to the intervention group or to the control group receiving usual care.\n\nIntervention group will receive a home exercise program 3 days weekly consisting of 30mins of strength and aerobic activity, utilizing a follow along exercise DVD and patient log to assist with compliance.\n\nThe two groups will be compared by 1) objective PT assessment with the Berg Balance and 6 minute walk test (before or after) Cycle 1 and 6, 2) subjective nursing assessment with the NHANES (National Health and Nutrition Examination Survey) and FACIT- F (Functional Assessment of Chronic Illness Therapy: Fatigue) prior to Cycle 1 (baseline),4 (midpoint), and following cycle 6 (completion).\n\nConclusion:\n\nPT directed home exercise program may improve CRF, functional decline, and QOL in elderly gynecologic oncology patients undergoing chemotherapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Endometrial, Ovarian, Cervix, Vaginal Cancer Initiating Chemotherapy\n* Age greater than or equal to 65yrs\n* ECOG (Eastern Cooperative Oncology Group) performance status less than 3\n* No current physical therapy intervention\n* English speaking\n\nExclusion Criteria:\n\n* Non-gynecologic malignancy\n* Recurrent cancer\n* Receiving radiation alone\n* Gait or balance disturbance'}, 'identificationModule': {'nctId': 'NCT01990066', 'briefTitle': 'Home Based Exercise Program for Elderly Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Single Institution Randomized Controlled Study of a Home Based Exercise Program to Reduce Functional Decline, Cancer Related Fatigue (CRF and Improve Quality of Life for the Elderly Gynecologic Oncology Patient)', 'orgStudyIdInfo': {'id': 'Pro00046121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Subjects randomized to intervention will receive Physical Therapist instructed exercise teaching. They will receive a home exercise DVD and flip ring of exercises. Subjects will be asked to perform home exercise 3 days weekly consisting of 13 strengthening/stretching exercises and 20 mins of aerobic exercise, walking or seated aerobics using ergometer. Subjects will record their exercise on a log and return on day 1 of every cycle.', 'interventionNames': ['Behavioral: Home Based Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Observation', 'description': 'Subjects randomized to observation will only have physical therapy assessment using the Berg Balance Test and 6min Walk Test at baseline and end point. These subjects will not receive any exercise teaching.'}], 'interventions': [{'name': 'Home Based Exercise', 'type': 'BEHAVIORAL', 'description': 'Subjects randomized to intervention will receive Physical Therapist instructed exercise teaching. They will receive a home exercise DVD and flip ring of exercises. Subjects will be asked to perform home exercise 3 days weekly consisting of 13 strengthening/stretching exercises and 20 mins of aerobic exercise, walking or seated aerobics using ergometer. Subjects will record their exercise on a log and return on day 1 of every cycle.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Raleigh Cancer Center', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}], 'overallOfficials': [{'name': 'Alicia S. Johnson, ADN-RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oncology Nursing Centers for Excellence', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}