Expired Study
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Durham, North Carolina 27710


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of early-stage breast or prostate cancer within the past 18 months - Dietary and physical activity habits and baseline functional status that places patient at risk - Potentially able to increase physical activity and to follow a low-fat, plant-based diet - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 65 and over Sex: - Male or female Menopausal status: - Not specified Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Able to speak and write English - No other malignancy within the past 5 years except nonmelanoma skin cancer - No other illness or condition that would preclude adherence to a plant-based diet or exercise PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified


NCT ID:

NCT00037024


Primary Contact:

Study Chair
Wendy Demark-Wahnefried, PhD
Duke Cancer Institute


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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