RENEW: Reach Out to Enhance Wellness in Older Survivors
- Compare the physical function over 1 year of overweight older long-term cancer
survivors assigned to immediate vs delayed exercise and dietary counseling.
- 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
After completion of study intervention, patients are followed periodically for up to 2
PROJECTED ACCRUAL: A total of 640 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label
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
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
Wendy Demark-Wahnefried, PhD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Veterans Affairs Medical Center - Durham||Durham, North Carolina 27705|