Breast Cancer Clinical Trial
Official title:
Project LEAD: Promoting Health Among Populations With Early Stage Cancers
RATIONALE: Telephone counseling by a nutritionist and a personal trainer may improve
physical function and quality of life in patients who have early-stage breast cancer or
prostate cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of a home-based, diet and
exercise-based counseling program with that of a standard home-based counseling program in
promoting health in patients who have early-stage breast cancer or prostate cancer.
OBJECTIVES:
- Compare the efficacy of a diet and exercise-based home-based counseling program versus
a standard home-based counseling program for improving physical function at 6 and 12
months for patients with early-stage breast or prostate cancer.
- Compare the effects of these home-based programs on diet quality, physical activity,
weight status, depression, and quality of life of these patients.
- Compare the factors, such as gender, race, and social support, that interact with these
home-based programs to predict program efficacy in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive home-based telephone counseling by a personal nutritionist and
a personal trainer.
- Arm II: Patients receive home-based standard health telephone counseling in unrelated
areas of cancer care (e.g., sun exposure, screening, and falls prevention).
In both arms, counseling continues every 2 weeks for 6 months.
Patients are followed at 6 months.
PROJECTED ACCRUAL: A total of 420 patients (210 per arm) will be accrued for this study.
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