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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00044980
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 23, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Malnutrition Prostate Cancer Procedure: nutritional support Procedure: quality-of-life assessment Not Applicable

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Other
Official Title: Fresh Start: Promoting Health in Prostate Cancer Survivors
Study Start Date : July 2002
Actual Primary Completion Date : September 2005
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over


  • 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


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00044980

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United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
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Study Chair: Wendy Demark-Wahnefried, PhD Duke Cancer Institute

Publications of Results:
Demark-Wahnefried W, Clipp E, Lipkus I, et al.: Results of FRESH START: a randomized controlled trial to improve diet and exercise behaviors in breast and prostate cancer survivors. [Abstract] J Clin Oncol 24 (Suppl 18): A-8503, 468s, 2006.

Other Publications:
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Responsible Party: Duke University Identifier: NCT00044980    
Other Study ID Numbers: Pro00008521
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: November 2012
Keywords provided by Duke University:
stage I prostate cancer
stage II B prostate cancer
stage II A prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Nutrition Disorders