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Completed

NCT Number: NCT00037024

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

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.

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Key information

Conditions

Breast Cancer Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Breast Neoplasms, Male Depression Fatigue Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Psychosocial Effects of Cancer and Its Treatment Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

65 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fatigue assessment and management

Procedure

nutritional support

Procedure

physical therapy

Procedure

psychosocial assessment and care

Procedure

quality-of-life assessment

Procedure

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Project LEAD: Promoting Health Among Populations With Early Stage Cancers

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Jan 27, 2003
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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