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

Tracking Information

First Received Date ^ICMJE

May 13, 2002

Last Updated Date

August 19, 2009

Start Date ^ICMJE

April 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00037024 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Project LEAD: Promoting Health Among Populations With Early Stage Cancers

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other

Condition ^ICMJE

Breast Cancer
Depression
Fatigue
Malnutrition
Prostate Cancer
Psychosocial Effects of Cancer and Its Treatment

Intervention ^ICMJE

Procedure: fatigue assessment and management
Procedure: nutritional support
Procedure: physical therapy
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00037024

Responsible Party

Study ID Numbers ^ICMJE

CDR0000069355, DUMC-1547-02-8R4ER, DUMC-1547-00-8R2ER, NCI-H02-0088

Study Sponsor ^ICMJE

Duke University

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Wendy Demark-Wahnefried, PhD

Duke University

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP