RENEW: Reach Out to Enhance Wellness in Older Survivors
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Duke University
- Enrollment
- 641
- Locations
- 2
- Primary Endpoint
- Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
RATIONALE: Exercise and dietary counseling may improve physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.
PURPOSE: This randomized clinical trial is studying two different schedules of exercise and dietary counseling to compare how well they work in improving physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.
Detailed Description
OBJECTIVES: Primary * Compare the physical function over 1 year of overweight older long-term cancer survivors assigned to immediate vs delayed exercise and dietary counseling. Secondary * Compare physical activity, saturated fat and vegetable and fruit intake, body mass index, depression, and general health and well being of experimental arm patients vs control arm patients. * Evaluate self-efficacy, social support, comorbidity, cancer-type, and gender as factors associated with program efficacy. * Determine the functional decline over a 2-year period in patients who undergo immediate vs delayed intervention. * Characterize the mathematical form, over a 2-year period, of physical functioning trajectories among older cancer survivors, including determining if the intervention effects are durable in those who receive the intervention initially and whether "catch-up" is possible in the delayed intervention arm. OUTLINE: This is a randomized study. Patients are stratified according to cancer type (colorectal vs breast or prostate), sex, age (65-74 years vs 75 years and over), and race (white vs non-white). Patients are randomized to 1 of 2 intervention arms. * Arm I (immediate intervention): Patients receive a personalized notebook of diet and exercise information, exercise equipment, and logbooks to record food intake and exercise behaviors. Patients undergo 20-minute telephone discussions with a health counselor once weekly for 3 weeks, every 2 weeks for 2 months, and then monthly for up to 1 year for a total of 15 sessions. Patients also undergo a 5-minute telephone survey to assess health every 3 months. * Arm II (delayed intervention): Patients undergo intervention as in arm I after a 1-year waiting period. After completion of study intervention, patients are followed periodically for up to 2 years. PROJECTED ACCRUAL: A total of 640 patients will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion
Time Frame: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
Secondary Outcomes
- Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion(one year)
- Physical activity as assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) at baseline and years 1 and 2 following study completion(one year)
- Dietary intake as assessed by 2-day dietary recalls at baseline and years 1 and 2 following study completion(one year)
- Body weight status as assessed by body mass index at baseline and years 1 and 2 following study completion(one year)
- Stage of readiness for exercise and dietary change as assessed by the stage of change algorithms at baseline and years 1 and 2 following study completion(one year)
- Depression and/or anxiety as assessed by Hospital Anxiety Depression Scale at baseline and years 1 and 2 following study completion(one year)
- Self-efficacy for exercise and dietary change assessed by self-efficacy algorithms at baseline and years 1 and 2 following study completion(one year)