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	Treatment or Intervention
stage I breast cancer stage II breast cancer stage I prostate cancer stage II prostate cancer Fatigue Nutrition psychosocial effects/treatment Quality of Life Depression	Procedure: fatigue assessment/management  Procedure: nutritional support  Procedure: physiotherapy  Procedure: psychosocial assessment/care  Procedure: quality-of-life assessment  Procedure: supportive care/therapy

Further Study Details: 

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.

Ages Eligible for Study:  65 Years and above,  Genders Eligible for Study:  Both

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

North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

Study chairs or principal investigators

Wendy Demark-Wahnefried, PhD,  Study Chair,  Duke Comprehensive Cancer Center   

Study ID Numbers:  CDR0000069355; DUMC-1547-02-8R4ER; DUMC-1547-00-8R2ER; NCI-H02-0088
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  May 13, 2002
ClinicalTrials.gov Identifier:  NCT00037024
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08