This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University Identifier:
First received: September 6, 2002
Last updated: February 21, 2017
Last verified: November 2012

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 Intervention
Malnutrition Prostate Cancer Procedure: nutritional support Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Other
Official Title: Fresh Start: Promoting Health in Prostate Cancer Survivors

Resource links provided by NLM:

Further study details as provided by Duke University:

Study Start Date: July 2002
Study Completion Date: December 2006
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00044980

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

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.

Responsible Party: Duke University Identifier: NCT00044980     History of Changes
Other Study ID Numbers: Pro00008521
Study First Received: September 6, 2002
Last Updated: February 21, 2017

Keywords provided by Duke University:
stage I prostate cancer
stage II B prostate cancer
stage II A prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Nutrition Disorders processed this record on September 19, 2017