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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Project LEAD: Promoting Health Among Populations With Early Stage Cancers

Conditions
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Breast Cancer, Depression, Fatigue, Malnutrition, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment

Intervention / Treatment
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* Procedure: fatigue assessment and management
* Procedure: nutritional support
* Procedure: physical therapy
* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: fatigue assessment and management|nan|
|Procedure: nutritional support|nan|
|Procedure: physical therapy|nan|
|Procedure: psychosocial assessment and care|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer, stage I prostate cancer, stage II B prostate cancer, stage II A prostate cancer, male breast cancer, fatigue, malnutrition, psychosocial effects of cancer and its treatment, depression