|
Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer Clinical research trials and Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer. Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer  Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
For Condition: stage 2 prostate cancer,psychosocial effects/treatment,Nutrition,stage 1 prostate cancer,Fatigue,Quality of Life,stage 1 breast cancer,stage 2 breast cancer,Depression
Status: No longer recruiting
Sponsor(s): Duke Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Telephone counseling by a nutritionist and a personal trainer may improve physical function and quality of life in patients who have early-stage breast cancer or prostate cancer. PURPOSE: Randomized clinical trial to compare the effectiveness of a home-based, diet and exercise-based counseling program with that of a standard home-based counseling program in promoting health in patients who have early-stage breast cancer or prostate cancer.
Details: OBJECTIVES: - Compare the efficacy of a diet and exercise-based home-based counseling program versus a standard home-based counseling program for improving physical function at 6 and 12 months for patients with early-stage breast or prostate cancer. - Compare the effects of these home-based programs on diet quality, physical activity, weight status, depression, and quality of life of these patients. - Compare the factors, such as gender, race, and social support, that interact with these home-based programs to predict program efficacy in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms. - Arm I: Patients receive home-based telephone counseling by a personal nutritionist and a personal trainer. - Arm II: Patients receive home-based standard health telephone counseling in unrelated areas of cancer care (e.g., sun exposure, screening, and falls prevention). In both arms, counseling continues every 2 weeks for 6 months. Patients are followed at 6 months. PROJECTED ACCRUAL: A total of 420 patients (210 per arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 65 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of early-stage breast or prostate cancer within the past 18 months - Dietary and physical activity habits and baseline functional status that places patient at risk - Potentially able to increase physical activity and to follow a low-fat, plant-based diet - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 65 and over Sex: - Male or female Menopausal status: - Not specified Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Able to speak and write English - No other malignancy within the past 5 years except nonmelanoma skin cancer - No other illness or condition that would preclude adherence to a plant-based diet or exercise 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
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000069355; DUMC-1547-02-8R4ER,NCI-H02-0088,DUMC-1547-00-8R2ER
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037024
Other Nutrition Studies:
1. Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
2. Physical Activity, Calcium, and Bone in Children
3. Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer
4. Promoting Healthy Lifestyles
Related Studies:
Other Nutrition Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
|
|
|
|
|
|
|
|
