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

Duke University

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Prostate Cancer

Colorectal Cancer

Treatments

Behavioral: behavioral dietary and exercise intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00303875

Pro00012963

DUMC-5477-03-12R0ER

DUMC-5477-04-12R1ER

CDR0000460231 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

641 patients

Sex

All

Ages

65 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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