Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00037024|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Depression Fatigue Malnutrition 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||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Project LEAD: Promoting Health Among Populations With Early Stage Cancers|
|Study Start Date :||April 2002|
|Actual Primary Completion Date :||February 2004|
|Actual Study Completion Date :||October 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037024
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Wendy Demark-Wahnefried, PhD||Duke Cancer Institute|