Exercise and Dietary Counseling in Improving Physical Activity, Nutrition, and Quality of Life in Older Long-Term Cancer Survivors Who Are Overweight
Condition: Breast Cancer; Colorectal Cancer; Prostate Cancer
MeSH terms: Breast Neoplasms; Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): behavioral dietary and exercise intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
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