Trial Information

RENEW: Reach Out to Enhance Wellness in Older Survivors

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.