Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Educational/Counseling/Training	Closed	18 and over	NCI	DUMC-1306-04-7R3ER DUMC-1306-01-7R2ER, NCI-H02-0090, NCT00044980

Objectives

1. 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).
2. Compare the health and quality of life of patients treated with these interventions.

Entry Criteria

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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• 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

Expected Enrollment

A total of 530 patients will be accrued for this study.

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.

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.

Demark-Wahnefried W, Clipp EC, McBride C, et al.: Design of FRESH START: a randomized trial of exercise and diet among cancer survivors. Med Sci Sports Exerc 35 (3): 415-24, 2003.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Duke Comprehensive Cancer Center

Wendy Demark-Wahnefried, PhD, Protocol chair		Ph: 919-681-3261

Registry Information
Official Title		Fresh Start: Promoting Health in Prostate Cancer Survivors
Trial Start Date		2002-07-22
Registered in ClinicalTrials.gov		NCT00044980
Date Submitted to PDQ		2002-06-17
Information Last Verified		2004-07-20
NCI Grant/Contract Number		CA14236, CAAG81191

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