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

Duke University

Status: Completed

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00037024

DUMC-1547-00-8R2ER

CDR0000069355

NCI-H02-0088

DUMC-1547-02-8R4ER

Pro00009493

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 65 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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