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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00037024

Enrollment

Unknown

Registered

2003-01-27

Start date

2002-04-30

Completion date

2004-10-31

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

stage I breast cancer, stage II breast cancer, stage I prostate cancer, stage II B prostate cancer, stage II A prostate cancer, male breast cancer, fatigue, malnutrition, psychosocial effects of cancer and its treatment, depression

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.

Interventions

PROCEDUREfatigue assessment and management

PROCEDUREnutritional support

PROCEDUREphysical therapy

PROCEDUREpsychosocial assessment and care

PROCEDUREquality-of-life assessment

Study design

Primary purpose

OTHER

Eligibility

Sex/Gender

ALL

Age

65 Years to 120 Years

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026