Breast Cancer Clinical Trial
Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
Durham North Carolina, 27710, United States
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