Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer - Full Text View

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 Cancer-Related Problem/Condition Fatigue Prostate Cancer	Procedure: fatigue assessment and management Procedure: nutritional support Procedure: physical therapy Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer Nutritional Support Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other

Official Title:	Project LEAD: Promoting Health Among Populations With Early Stage Cancers

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

April 2002

Detailed Description:

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

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037024

Locations


United States, North Carolina
	Duke Comprehensive Cancer Center
	Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

National Cancer Institute (NCI)

Investigators


Study Chair:	Wendy Demark-Wahnefried, PhD	Duke University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Demark-Wahnefried W, Morey MC, Clipp EC, Pieper CF, Snyder DC, Sloane R, Cohen HJ. Leading the Way in Exercise and Diet (Project LEAD): intervening to improve function among older breast and prostate cancer survivors. Control Clin Trials. 2003 Apr;24(2):206-23.

Study ID Numbers:	CDR0000069355, DUMC-1547-02-8R4ER, DUMC-1547-00-8R2ER, NCI-H02-0088
First Received:	May 13, 2002
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00037024
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer

stage II breast cancer

stage I prostate cancer

stage II prostate cancer

male breast cancer

fatigue

malnutrition

psychosocial effects/treatment

quality of life

depression

Study placed in the following topic categories:

Fatigue

Depression

Prostatic Diseases

Skin Diseases

Genital Neoplasms, Male

Quality of Life

Breast Neoplasms

Urogenital Neoplasms

Depressive Disorder

Genital Diseases, Male

Signs and Symptoms

Malnutrition

Breast Neoplasms, Male

Prostatic Neoplasms

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	Duke University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00037024