NCT Number: NCT00303875
Exercise and Dietary Counseling in Improving Physical Activity, Nutrition, and Quality of Life in Older Long-Term Cancer Survivors Who Are Overweight
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.
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Notify MeKey information
Conditions
Age range
65 year–120 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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
Time frame: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
Secondary outcomes
-
Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
Sponsors and collaborators
Lead sponsor
Duke University
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
RENEW: Reach Out to Enhance Wellness in Older Survivors
Important dates
- Study start
- 2003
- Primary completion
- 2008
- Study completion
- 2009
- First posted
- Mar 17, 2006
- Registry last updated
- Feb 23, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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