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RENEW: Reach Out to Enhance Wellness in Older Survivors

Phase 2
65 Years
Not Enrolling
Breast Cancer, Colorectal Cancer, Prostate Cancer

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Trial Information

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
waiting period.

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.

Inclusion Criteria


- Diagnosed colorectal, prostate, or female breast cancer

- At least 5 years beyond date of diagnosis with no clinical evidence of
progressive disease or second primaries

- Body mass index ≥ 25 kg/m^2 and < 40 kg/m^2

- Currently exercising < 150 minutes/week

- Hormone receptor status not specified


- Menopausal status not specified

- No serious intercurrent medical condition or disability that could preclude study
treatment, including any of the following:

- Severe orthopedic condition or scheduled hip or knee replacement within the next
6 months

- Paralysis

- End-stage renal disease

- Dementia

- Unstable angina

- Heart attack, congestive heart failure, or pulmonary condition that required
oxygen or hospitalization within the past 6 months

- Ability to read, write, and speak English


- No concurrent warfarin

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Outcome Measure:

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

Outcome Description:

one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Wendy Demark-Wahnefried, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute


United States: Federal Government

Study ID:




Start Date:

December 2003

Completion Date:

May 2009

Related Keywords:

  • Breast Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent breast cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • recurrent colon cancer
  • stage I colon cancer
  • stage II colon cancer
  • stage III colon cancer
  • stage IV colon cancer
  • recurrent rectal cancer
  • stage I rectal cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Prostatic Neoplasms



Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705