Community-Based Exercise and Nutrition Training and Education Program for Cancer Survivors
NCT Number: NCT06565260
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm|Malignant Solid Neoplasm
Interventions: OTHER: Exercise Intervention|OTHER: Medical Device Usage and Evaluation|OTHER: Nutritional Intervention|OTHER: Physical Performance Testing|OTHER: Questionnaire Administration
Sponsor: Roswell Park Cancer Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-30
Completion Date: 2029-08-30
Locations: Roswell Park Cancer Institute, Buffalo, New York, 14263, United States

Summary:
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.

Primary Outcome Measures: Proportion of patients still on study (Feasibility), 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., At the end of the 12 week intervention|Percentage of patients on study after 12 weeks who complete at least 70% of intervention activities (Acceptability), 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., At 12 weeks|Patient satisfaction (Acceptability), 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., Baseline to 3 months post-intervention
Secondary Outcome Measures: Changes in exercise and nutrition self-efficacy, 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., Baseline to 3 months post-intervention