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| Sponsor: | Duke University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00037024 |
Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Official Title: | Project LEAD: Promoting Health Among Populations With Early Stage Cancers |
| Study Start Date: | April 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.
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| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Study Chair: | Wendy Demark-Wahnefried, PhD | Duke University |
More Information
| Study ID Numbers: | CDR0000069355, DUMC-1547-02-8R4ER, DUMC-1547-00-8R2ER, NCI-H02-0088 |
| Study First Received: | May 13, 2002 |
| Last Updated: | August 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00037024 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer stage I prostate cancer stage II prostate cancer male breast cancer |
fatigue malnutrition psychosocial effects of cancer and its treatment depression |
|
Depression Fatigue Prostatic Diseases Genital Neoplasms, Male Skin Diseases Breast Neoplasms Urogenital Neoplasms Genital Diseases, Male Depressive Disorder Behavioral Symptoms |
Signs and Symptoms Neoplasms Malnutrition Neoplasms by Site Mental Disorders Mood Disorders Nutrition Disorders Prostatic Neoplasms Breast Diseases |