Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors
Summary
RATIONALE: A breast cancer rehabilitation program and exercise therapy may help improve the quality of life of breast cancer survivors.
PURPOSE: This clinical trial studies a breast cancer rehabilitation program in improving quality of life in breast cancer survivors.
Description
PRIMARY OBJECTIVES:
I. To estimate accrual, retention, adherence, and participation of breast cancer survivors to a breast cancer rehabilitation program.
II. To estimate the variability of weight, six-minute walk, quality of life and other psychosocial and physical measures in women participating in the BCRP.
SECONDARY OBJECTIVES:
I. To assess changes in the anthropometric, psychosocial, and physical outcomes over the six-month period of the BCRP.
II. To document the types and the rates of adverse events associated with the BCRP.
OUTLINE:
Patients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20 minutes of resistance training exercise.
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Stage I Breast Cancer
Intervention
questionnaire administration, exercise intervention, quality-of-life assessment, survey administration, management of therapy complications, psychosocial assessment and care
Location
Wake Forest University Health Sciences
Winston-Salem
North Carolina
United States
27157
Status
Recruiting
Source
Wake Forest University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01113554
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Exercise Test
Controlled physical activity, more strenuous than at rest, which is performed in order to allow assessment of physiological functions, particularly cardiovascular and pulmonary, but also aerobic capacity. Maximal (most intense) exercise is usually required but submaximal exercise is also used. The intensity of exercise is often graded, using criteria such as rate of work done, oxygen consumption, and heart rate.
Quality Assurance, Health Care
Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps.
Quality-adjusted Life Years
A measurement index derived from a modification of standard life-table procedures and designed to take account of the quality as well as the duration of survival. This index can be used in assessing the outcome of health care procedures or services. (BIOETHICS Thesaurus, 1994)
Quality Of Life
A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral and social environment; the overall condition of a human life.
Sickness Impact Profile
A quality-of-life scale developed in the United States in 1972 as a measure of health status or dysfunction generated by a disease. It is a behaviorally based questionnaire for patients and addresses activities such as sleep and rest, mobility, recreation, home management, emotional behavior, social interaction, and the like. It measures the patient's perceived health status and is sensitive enough to detect changes or differences in health status occurring over time or between groups. (From Medical Care, vol.xix, no.8, August 1981, p.787-805)
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