Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 7:26 AM
Study NCT ID:
NCT06565260
Status:
RECRUITING
Last Update Posted:
2025-10-29
First Post:
2024-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-Based Exercise and Nutrition Training and Education Program for Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2024-08-19', 'studyFirstSubmitQcDate': '2024-08-19', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients still on study (Feasibility)', 'timeFrame': 'At the end of the 12 week intervention', 'description': "Feasibility will be defined as the proportion of patients still on study at the end of the 12 weeks intervention. The feasibility rate will be estimated using a 90% credible region obtained by Jeffrey's prior method. The lower bound will define a plausible lower limit for true (unobserved) feasibility rate. Will be summarized using the appropriate descriptive statistics and graphical summaries. Continuous variables will be summarized using the mean, median, standard deviation, and percentiles. Categorical variables will be summarized using frequencies and relative frequencies."}, {'measure': 'Percentage of patients on study after 12 weeks who complete at least 70% of intervention activities (Acceptability)', 'timeFrame': 'At 12 weeks', 'description': 'Acceptability will be determined by measuring adherence to the intervention. The adherence rate will be considered acceptable if patients complete at least 70% of the intervention activities. Will be summarized using the appropriate descriptive statistics and graphical summaries. Continuous variables will be summarized using the mean, median, standard deviation, and percentiles. Categorical variables will be summarized using frequencies and relative frequencies.'}, {'measure': 'Patient satisfaction (Acceptability)', 'timeFrame': 'Baseline to 3 months post-intervention', 'description': 'Patient satisfaction will be determined through surveys. Will be summarized using the appropriate descriptive statistics and graphical summaries. Continuous variables will be summarized using the mean, median, standard deviation, and percentiles. Categorical variables will be summarized using frequencies and relative frequencies.'}], 'secondaryOutcomes': [{'measure': 'Changes in exercise and nutrition self-efficacy', 'timeFrame': 'Baseline to 3 months post-intervention', 'description': 'The self-reported outcomes will be summarized using the appropriate descriptive statistics. Self-reported outcomes will be compared using paired t-tests. Test assumptions will be verified graphically, and transformation or non-parametric methods (e.g., sign test) will be considered, as appropriate.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphatic System Neoplasm', 'Malignant Solid Neoplasm']}, 'descriptionModule': {'briefSummary': "This clinical trial evaluates whether a supervised community-based exercise and nutrition program is usable and effective for improving cancer survivors' confidence for maintaining their physical activity and nutrition. Cancer survivors often experience problems with the musculoskeletal system (bones, joints, muscles, connective tissue), the cardiopulmonary system (heart, blood vessels and lungs) and the metabolic system (how the body's cells change food into energy) following treatment. There is substantial evidence that physical activity, diet, and weight management can improve quality of life (emotional and physical well-being) and physical fitness. Information gathered from this study may help researchers determine whether participating in a community-based exercise/nutrition training and education program may improve levels of fitness, cardiovascular health, and quality of life for cancer survivors.", 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To assess the feasibility and acceptability of a 12-week supervised community-based exercise/nutrition training and education program for cancer survivors.\n\nSECONDARY OBJECTIVE:\n\nI. To assess the effectiveness of a supervised exercise and nutrition training and education program by evaluating pre-post changes in exercise self-efficacy.\n\nTERTIARY OBJECTIVE:\n\nI. To assess changes in functional performance and quality of life (QoL).\n\nOUTLINE:\n\nPatients participate in a supervised, community-based exercise program consisting of aerobic and resistance exercise over 45-60 minutes twice a week (BIW) for 12 weeks. Beginning at week 2, patients also receive nutrition education and training once a week (QW) for 10 weeks. Patients also wear an activity tracker throughout the study.\n\nAfter completion of study intervention, patients are followed up at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Have had a previous cancer diagnosis and completed all therapy OR are a caregiver for a patient who has had a previous cancer diagnosis.\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related interventions.\n\nExclusion Criteria:\n\n* Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia including atrial fibrillation (AFIB), multiple myeloma, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Have orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise.\n* Are pregnant or nursing.\n* History of a stem cell transplant.\n* Currently on steroids.\n* Unwilling or unable to follow protocol requirements.\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in the study."}, 'identificationModule': {'nctId': 'NCT06565260', 'briefTitle': 'Community-Based Exercise and Nutrition Training and Education Program for Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'Feasibility of a Community-Based Cancer Survivor Exercise and Nutrition Education Program: Effects on Self-Efficacy, Quality of Life and Functional Performance', 'orgStudyIdInfo': {'id': 'I-3953124'}, 'secondaryIdInfos': [{'id': 'NCI-2024-06518', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'I-3953124', 'type': 'OTHER', 'domain': 'Roswell Park Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive Care (exercise/nutrition program)', 'description': 'Patients participate in a supervised, community-based exercise program consisting of aerobic and resistance exercise over 45-60 minutes BIW for 12 weeks. Beginning at week 2, patients also receive nutrition education and training QW for 10 weeks. Patients also wear an activity tracker throughout the study.', 'interventionNames': ['Other: Exercise Intervention', 'Other: Medical Device Usage and Evaluation', 'Other: Nutritional Intervention', 'Other: Physical Performance Testing', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Exercise Intervention', 'type': 'OTHER', 'description': 'Participate in exercise program', 'armGroupLabels': ['Supportive Care (exercise/nutrition program)']}, {'name': 'Medical Device Usage and Evaluation', 'type': 'OTHER', 'description': 'Wear an activity tracker', 'armGroupLabels': ['Supportive Care (exercise/nutrition program)']}, {'name': 'Nutritional Intervention', 'type': 'OTHER', 'description': 'Participate in nutrition program', 'armGroupLabels': ['Supportive Care (exercise/nutrition program)']}, {'name': 'Physical Performance Testing', 'type': 'OTHER', 'otherNames': ['Physical Fitness Testing', 'Physical Function Testing'], 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive Care (exercise/nutrition program)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive Care (exercise/nutrition program)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew D. Ray', 'role': 'CONTACT', 'email': 'Andrew.Ray@roswellpark.org', 'phone': '716-845-2381'}, {'name': 'Andrew D. Ray', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Andrew D Ray', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}