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| Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00044980 |
Purpose
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 Quality of Life |
Procedure: nutritional support Procedure: quality-of-life assessment |
| MedlinePlus related topics: | Cancer Exercise and Physical Fitness Nutritional Support Prostate Cancer |
| Study Type: | Interventional |
| Study Design: | Other, Randomized, Active Control |
| Official Title: | Fresh Start: Promoting Health in Prostate Cancer Survivors |
| Study Start Date: | July 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, North Carolina | |||||
| Duke Comprehensive Cancer Center | |||||
| Durham, North Carolina, United States, 27710 | |||||
| Duke University |
| National Cancer Institute (NCI) |
| Study Chair: | Wendy Demark-Wahnefried, PhD | Duke University |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
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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.
  |
| Study ID Numbers: | CDR0000069500, DUMC-1306-04-7R3ER, DUMC-1306-01-7R2ER, NCI-H02-0090 |
| First Received: | September 6, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00044980 |
| Health Authority: | United States: Federal Government |
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