Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: An individualized, computer-designed health program may promote changes in diet and physical activity and may improve quality of life in patients who have early-stage prostate cancer. PURPOSE: Randomized clinical trial to compare the effectiveness of an individualized, computer-designed diet and exercise-based counseling program with that of a standard counseling program in promoting health in patients who have early-stage prostate cancer.

Detailed Description
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OBJECTIVES: Compare the effectiveness of a computer-tailored, correspondence course vs standardized materials in promoting changes in diet and physical activity (PA) behaviors in patients with early stage prostate or breast (closed to accrual as of 8/1/03) cancer who currently do not practice goal behavior in at least 2 of the following 3 areas: performance of moderate PA for at least 150 minutes per week; consumption of at least 5 servings of vegetables or fruit daily; or consumption of a diet with less than 30% fat (with less than 10% of kilocalories from either saturates or polyunsaturates). Compare the health and quality of life of patients treated with these interventions. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients participate in a computer-tailored, correspondence course comprising personalized diet and exercise intervention and other health information over a 10-month period. Arm II: Patients receive usual care comprising standardized print materials related to diet, exercise, cancer, and other pertinent health issues over a 10-month period. In both arms, diet and exercise behavior, quality of life, co-morbidity status, depression, social support, worry, self efficacy, and coping style are assessed during phone interviews conducted at baseline, after completion of 10 months of study intervention, and then at 1 year. Intervention usefulness is assessed after completion of 10 months of study intervention. Patients in both arms who live within a 1-hour drive from Duke University Medical Center may undergo blood draw to test for substances related to fruit and vegetable intake and measurement of height and weight. Patients may also be asked to wear a pedometer for a 1-week period. PROJECTED ACCRUAL: A total of 530 patients will be accrued for this study.

Official Title
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Fresh Start: Promoting Health in Prostate Cancer Survivors

Conditions
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Malnutrition, Prostate Cancer

Intervention / Treatment
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* Procedure: nutritional support
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosed with early stage prostate or breast (closed to accrual as of 8/1/03) cancer within the past 9 months Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Breast cancer (closed to accrual as of 8/1/03) patients must be female Menopausal status Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No other malignancy within the past 5 years except nonmelanoma skin cancer Able to speak and write in English Performs insufficient exercise Maintains a high-fat, low-vegetable, low-fruit diet 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: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

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
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: nutritional support|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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malnutrition, stage I prostate cancer, stage II B prostate cancer, stage II A prostate cancer