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

Study Overview
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Brief Summary
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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
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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.

Official Title
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RENEW: Reach Out to Enhance Wellness in Older Survivors

Conditions
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Breast Cancer, Colorectal Cancer, Prostate Cancer

Intervention / Treatment
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* Behavioral: behavioral dietary and exercise intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Wait-list control<br>Wait-list control received diet & exercise counseling during year 2 as a courtesy | |
| Experimental: Lifestyle counseling<br>subjects randomized to receive diet & exercise counseling for one year | Behavioral: behavioral dietary and exercise intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion | one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. | one year | 
| Physical activity as assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) at baseline and years 1 and 2 following study completion | one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. | one year | 
| Dietary intake as assessed by 2-day dietary recalls at baseline and years 1 and 2 following study completion | one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. | one year | 
| Body weight status as assessed by body mass index at baseline and years 1 and 2 following study completion | one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. | one year | 
| Depression and/or anxiety as assessed by Hospital Anxiety Depression Scale at baseline and years 1 and 2 following study completion | one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. | one year | 
| Self-efficacy for exercise and dietary change assessed by self-efficacy algorithms at baseline and years 1 and 2 following study completion | one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. | one year | 
| 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 | one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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