NCT00037024

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

Project LEAD: Promoting Health Among Populations With Early Stage Cancers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 65 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	fatigue assessment and management
PROCEDURE	nutritional support
PROCEDURE	physical therapy
PROCEDURE	psychosocial assessment and care
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2002-04-01
• Primary completion: 2004-02-01
• Completion: 2004-10-01
• First posted: 2003-01-27
• Last updated: 2017-02-23

Locations

1 site across 1 country: United States