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Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: May 13, 2002   Last Updated: August 19, 2009   History of Changes
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Depression Nutritional Support Prostate Cancer
U.S. FDA Resources

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

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.

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

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 of cancer and its treatment
depression

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 22, 2009



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