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Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer Clinical research trials and Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer. Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer  Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer
Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer
For Condition: Quality of Life,stage 2 prostate cancer,Nutrition,stage 1 prostate cancer
Status: Recruiting
Sponsor(s): Duke Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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-stageprostate 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.
Details: OBJECTIVES: - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WendyDemark-Wahnefried, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Denise Snyder 866-458-1913
Additional Information:
Study ID Numbers: CDR0000069500; NCI-H02-0090,DUMC-1306-01-7R2ER,DUMC-1306-04-7R3ER
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044980
Other Nutrition Studies:
1. Radiation Therapy Plus Amifostine in Treating Patients With Primary Prostate Cancer
2. Brachytherapy in Treating Patients With Recurrent Prostate Cancer
3. Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer
4. Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer
5. Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
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Other Nutrition Clinical Trials
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Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer
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