Project LEAD: Promoting Health Among Populations With Early Stage Cancers
65 Years
N/A
Both
Breast Cancer, Depression, Fatigue, Malnutrition, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment
Trial Information
Project LEAD: Promoting Health Among Populations With Early Stage Cancers
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
N/A
Principal Investigator
Wendy Demark-Wahnefried, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Duke Cancer Institute
Authority:
United States: Federal Government
Study ID:
Pro00009493 CDR0000069355
NCT ID:
NCT00037024
Start Date:
April 2002
Completion Date:
October 2004
Related Keywords:
- Breast Cancer
- Depression
- Fatigue
- Malnutrition
- Prostate Cancer
- Psychosocial Effects of Cancer and Its Treatment
- stage I breast cancer
- stage II breast cancer
- stage I prostate cancer
- stage II B prostate cancer
- stage II A prostate cancer
- male breast cancer
- fatigue
- malnutrition
- psychosocial effects of cancer and its treatment
- depression
- Breast Neoplasms
- Depression
- Depressive Disorder
- Fatigue
- Prostatic Neoplasms
- Malnutrition
Name | Location |
|---|---|
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
