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Project LEAD: Promoting Health Among Populations With Early Stage Cancers


N/A
65 Years
N/A
Not Enrolling
Both
Breast Cancer, Depression, Fatigue, Malnutrition, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

Project LEAD: Promoting Health Among Populations With Early Stage Cancers


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.

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

Type of Study:

Interventional

Study Design:

N/A

Principal Investigator

Wendy Demark-Wahnefried, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

Pro00009493 CDR0000069355

NCT ID:

NCT00037024

Start Date:

April 2002

Completion Date:

October 2004

Related Keywords:

  • Breast Cancer
  • Depression
  • Fatigue
  • Malnutrition
  • Prostate Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • 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
  • Breast Neoplasms
  • Depression
  • Depressive Disorder
  • Fatigue
  • Prostatic Neoplasms
  • Malnutrition

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710