Exercise and Dietary Counseling in Improving Physical Activity, Nutrition, and Quality of Life in Older Long-Term Cancer Survivors Who Are Overweight
- Conditions
- Colorectal CancerBreast CancerProstate Cancer
- Interventions
- Behavioral: behavioral dietary and exercise intervention
- Registration Number
- NCT00303875
- Lead Sponsor
- Duke University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 641
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lifestyle counseling behavioral dietary and exercise intervention subjects randomized to receive diet \& exercise counseling for one year
- Primary Outcome Measures
Name Time Method 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 one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
- Secondary Outcome Measures
Name Time Method Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion one year 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 one year 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 one year 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 one year 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 one year 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 one year 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 one year one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
Trial Locations
- Locations (2)
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States