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

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

Summary

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.

Description

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.

Study Design

N/A

Conditions

Breast Cancer

Intervention

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

Location

Duke Comprehensive Cancer Center
Durham
North Carolina
United States
27710

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

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

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