Clinical trial NCT00303875: Exercise and Dietary Counseling in Improving Physical Activity, Nutrition, and Quality of Life in Older Long-Term Cancer Survivors Who Are Overweight
Official title: RENEW: Reach Out to Enhance Wellness in Older Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Colorectal Cancer
Prostate Cancer
Keywords: 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
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-03-17
Enrollment: 641
Sex: ALL
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* 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

PATIENT CHARACTERISTICS:

* 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

PRIOR CONCURRENT THERAPY:

* No concurrent warfarin

Primary outcomes:
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
timeFrame: one year
Secondary outcomes:
measure: Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion
timeFrame: one year
measure: Physical activity as assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) at baseline and years 1 and 2 following study completion
timeFrame: one year
measure: Dietary intake as assessed by 2-day dietary recalls at baseline and years 1 and 2 following study completion
timeFrame: one year
measure: Body weight status as assessed by body mass index at baseline and years 1 and 2 following study completion
timeFrame: one year
measure: Depression and/or anxiety as assessed by Hospital Anxiety Depression Scale at baseline and years 1 and 2 following study completion
timeFrame: one year
measure: Self-efficacy for exercise and dietary change assessed by self-efficacy algorithms at baseline and years 1 and 2 following study completion
timeFrame: one year
measure: 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
timeFrame: one year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Veterans Affairs Medical Center - Durham
state: North Carolina
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Duke Cancer Institute
name: Wendy Demark-Wahnefried, PhD
role: STUDY_CHAIR
References:
citation: Demark-Wahnefried W, Morey MC, Sloane R, Snyder DC, Miller PE, Hartman TJ, Cohen HJ. Reach out to enhance wellness home-based diet-exercise intervention promotes reproducible and sustainable long-term improvements in health behaviors, body weight, and physical functioning in older, overweight/obese cancer survivors. J Clin Oncol. 2012 Jul 1;30(19):2354-61. doi: 10.1200/JCO.2011.40.0895. Epub 2012 May 21.
citation: Miller PE, Morey MC, Hartman TJ, Snyder DC, Sloane R, Cohen HJ, Demark-Wahnefried W. Dietary patterns differ between urban and rural older, long-term survivors of breast, prostate, and colorectal cancer and are associated with body mass index. J Acad Nutr Diet. 2012 Jun;112(6):824-31, 831.e1. doi: 10.1016/j.jand.2012.02.021.
citation: Mosher CE, Sloane R, Morey MC, Snyder DC, Cohen HJ, Miller PE, Demark-Wahnefried W. Associations between lifestyle factors and quality of life among older long-term breast, prostate, and colorectal cancer survivors. Cancer. 2009 Sep 1;115(17):4001-9. doi: 10.1002/cncr.24436.
citation: Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.
citation: Snyder DC, Morey MC, Sloane R, Stull V, Cohen HJ, Peterson B, Pieper C, Hartman TJ, Miller PE, Mitchell DC, Demark-Wahnefried W. Reach out to ENhancE Wellness in Older Cancer Survivors (RENEW): design, methods and recruitment challenges of a home-based exercise and diet intervention to improve physical function among long-term survivors of breast, prostate, and colorectal cancer. Psychooncology. 2009 Apr;18(4):429-39. doi: 10.1002/pon.1491.
citation: Morey MC, Blair CK, Sloane R, Cohen HJ, Snyder DC, Demark-Wahnefried W. Group trajectory analysis helps to identify older cancer survivors who benefit from distance-based lifestyle interventions. Cancer. 2015 Dec 15;121(24):4433-40. doi: 10.1002/cncr.29684. Epub 2015 Oct 29.
citation: Winger JG, Mosher CE, Rand KL, Morey MC, Snyder DC, Demark-Wahnefried W. Diet and exercise intervention adherence and health-related outcomes among older long-term breast, prostate, and colorectal cancer survivors. Ann Behav Med. 2014 Oct;48(2):235-45. doi: 10.1007/s12160-014-9598-7.
citation: Blair CK, Morey MC, Desmond RA, Cohen HJ, Sloane R, Snyder DC, Demark-Wahnefried W. Light-intensity activity attenuates functional decline in older cancer survivors. Med Sci Sports Exerc. 2014 Jul;46(7):1375-83. doi: 10.1249/MSS.0000000000000241.
citation: Demark-Wahnefried W, Morey MC, Sloane R, Snyder DC, Cohen HJ. Promoting healthy lifestyles in older cancer survivors to improve health and preserve function. J Am Geriatr Soc. 2009 Nov;57 Suppl 2(Suppl 2):S262-4. doi: 10.1111/j.1532-5415.2009.02507.x.
citation: Miller P, Demark-Wahnefried W, Snyder DC, Sloane R, Morey MC, Cohen H, Kranz S, Mitchell DC, Hartman TJ. Dietary supplement use among elderly, long-term cancer survivors. J Cancer Surviv. 2008 Sep;2(3):138-48. doi: 10.1007/s11764-008-0060-3. Epub 2008 Jul 11.