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

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT00037024

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

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 Design

Study Type:

Interventional

Primary Purpose:

Other

Official Title:

Project LEAD: Promoting Health Among Populations With Early Stage Cancers

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Feb 1, 2004

Actual Study Completion Date :

Oct 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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