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 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Depression Fatigue Malnutrition Nutritional Support Prostate Cancer

U.S. FDA Resources

Further study details as provided by Duke University:

Study Start Date:	April 2002
Study Completion Date:	October 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

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 Cancer Institute

More Information

Additional Information:

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

Publications:

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.

Demark-Wahnefried W, Clipp EC, Morey MC, Pieper CF, Sloane R, Snyder DC, Cohen HJ. Physical function and associations with diet and exercise: Results of a cross-sectional survey among elders with breast or prostate cancer. Int J Behav Nutr Phys Act. 2004 Oct 29;1(1):16.

Demark-Wahnefried W, Clipp EC, Morey MC, Pieper CF, Sloane R, Snyder DC, Cohen HJ. Lifestyle intervention development study to improve physical function in older adults with cancer: outcomes from Project LEAD. J Clin Oncol. 2006 Jul 20;24(21):3465-73.

Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT00037024 History of Changes
Other Study ID Numbers:	Pro00009493 CDR0000069355, DUMC-1547-02-8R4ER, DUMC-1547-00-8R2ER, NCI-H02-0088
Study First Received:	May 13, 2002
Last Updated:	November 16, 2012
Health Authority:	United States: Federal Government

Keywords provided by Duke University:

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

Additional relevant MeSH terms:

Breast Neoplasms
Depression
Depressive Disorder
Fatigue
Prostatic Neoplasms
Malnutrition
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

Behavioral Symptoms
Mood Disorders
Mental Disorders
Signs and Symptoms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Nutrition Disorders

ClinicalTrials.gov processed this record on May 23, 2013