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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University Identifier:
First received: May 13, 2002
Last updated: February 21, 2017
Last verified: November 2012

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
Study Design: Primary Purpose: Other
Official Title: Project LEAD: Promoting Health Among Populations With Early Stage Cancers

Resource links provided by NLM:

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:


  • 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.


Ages Eligible for Study:   65 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 65 and over


  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00037024

United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Study Chair: Wendy Demark-Wahnefried, PhD Duke Cancer Institute
  More Information


Responsible Party: Duke University Identifier: NCT00037024     History of Changes
Other Study ID Numbers: Pro00009493
Study First Received: May 13, 2002
Last Updated: February 21, 2017

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
psychosocial effects of cancer and its treatment

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Behavioral Symptoms
Signs and Symptoms
Nutrition Disorders processed this record on August 16, 2017