Exercise and Dietary Counseling in Improving Physical Activity, Nutrition, and Quality of Life in Older Long-Term Cancer Survivors Who Are Overweight

• Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion [ Time Frame: one year ] [ Designated as safety issue: No ]
  one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
• Physical activity as assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) at baseline and years 1 and 2 following study completion [ Time Frame: one year ] [ Designated as safety issue: No ]
  one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
• Dietary intake as assessed by 2-day dietary recalls at baseline and years 1 and 2 following study completion [ Time Frame: one year ] [ Designated as safety issue: No ]
  one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
• Body weight status as assessed by body mass index at baseline and years 1 and 2 following study completion [ Time Frame: one year ] [ Designated as safety issue: No ]
  one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
• Depression and/or anxiety as assessed by Hospital Anxiety Depression Scale at baseline and years 1 and 2 following study completion [ Time Frame: one year ] [ Designated as safety issue: No ]
  one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
• Self-efficacy for exercise and dietary change assessed by self-efficacy algorithms at baseline and years 1 and 2 following study completion [ Time Frame: one year ] [ Designated as safety issue: No ]
  one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
• 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 [ Time Frame: one year ] [ Designated as safety issue: No ]
  one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

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.

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.

• Breast Cancer
• Colorectal Cancer
• Prostate Cancer

• No Intervention: Wait-list control
  Wait-list control received diet & exercise counseling during year 2 as a courtesy
• Experimental: Lifestyle counseling
  subjects randomized to receive diet & exercise counseling for one year
  Intervention: Behavioral: behavioral dietary and exercise intervention

• 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.
• 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.
• 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.
• 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.
• 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.

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