Clinical trial · Interventional
Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer
Fresh Start: Promoting Health in Prostate Cancer Survivors
NCT00044980CI-TRIAL-00026100completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malnutrition | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nutritional support | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (20)
- BACKGROUNDDemark-Wahnefried W, Clipp EC, McBride C, Lobach DF, Lipkus I, Peterson B, Clutter Snyder D, Sloane R, Arbanas J, Kraus WE. Design of FRESH START: a randomized trial of exercise and diet among cancer survivors. Med Sci Sports Exerc. 2003 Mar;35(3):415-24. doi: 10.1249/01.MSS.0000053704.28156.0F. PMID 12618570
- BACKGROUNDMacri JM, Downs SM, Demark-Wahnefried W, Snyder DC, Lobach DF. A simple, flexible and scalable approach for generating tailored questionnaires and health education messages. Comput Inform Nurs. 2005 Nov-Dec;23(6):316-21. doi: 10.1097/00024665-200511000-00007. PMID 16292046
- RESULTChristy SM, Mosher CE, Sloane R, Snyder DC, Lobach DF, Demark-Wahnefried W. Long-term dietary outcomes of the FRESH START intervention for breast and prostate cancer survivors. J Am Diet Assoc. 2011 Dec;111(12):1844-51. doi: 10.1016/j.jada.2011.09.013. PMID 22117660
- RESULTOttenbacher AJ, Day RS, Taylor WC, Sharma SV, Sloane R, Snyder DC, Kraus WE, Demark-Wahnefried W. Exercise among breast and prostate cancer survivors--what are their barriers? J Cancer Surviv. 2011 Dec;5(4):413-9. doi: 10.1007/s11764-011-0184-8. Epub 2011 May 20. PMID 21598023
- RESULTDemark-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.
- RESULTDemark-Wahnefried W, Clipp EC, Lipkus IM, Lobach D, Snyder DC, Sloane R, Peterson B, Macri JM, Rock CL, McBride CM, Kraus WE. Main outcomes of the FRESH START trial: a sequentially tailored, diet and exercise mailed print intervention among breast and prostate cancer survivors. J Clin Oncol. 2007 Jul 1;25(19):2709-18. doi: 10.1200/JCO.2007.10.7094. PMID 17602076
- RESULTSnyder DC, Sloane R, Lobach D, Lipkus I, Clipp E, Kraus WE, Demark-Wahnefried W; Fresh Start study. Agreement between a brief mailed screener and an in-depth telephone survey: observations from the Fresh Start study. J Am Diet Assoc. 2004 Oct;104(10):1593-6. doi: 10.1016/j.jada.2004.07.024.