Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
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.
Psychosocial Effects of Cancer and Its Treatment
Procedure: fatigue assessment and management
Procedure: nutritional support
Procedure: physical therapy
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
|Study Design:||Primary Purpose: Other|
|Official Title:||Project LEAD: Promoting Health Among Populations With Early Stage Cancers|
|Study Start Date:||April 2002|
|Study Completion Date:||October 2004|
|Primary Completion Date:||February 2004 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00037024
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Wendy Demark-Wahnefried, PhD||Duke Cancer Institute|