Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer

2014-08-27 03:56:06 | BioPortfolio


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.



- 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.

Study Design



Breast Cancer


fatigue assessment and management, nutritional support, physical therapy, psychosocial assessment and care, quality-of-life assessment


Duke Comprehensive Cancer Center
North Carolina
United States


Active, not recruiting


National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:56:06-0400

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