Overview

This trial is active, not recruiting.

Conditions stage i breast cancer, stage ii breast cancer, stage iiia breast cancer, stage iiib breast cancer, stage iiic breast cancer, stage iv breast cancer
Treatments questionnaire administration, exercise intervention, quality-of-life assessment, survey administration, management of therapy complications, psychosocial assessment and care
Sponsor Comprehensive Cancer Center of Wake Forest University
Start date June 2010
End date October 2013
Trial size 25 participants
Trial identifier NCT01113554, CCCWFU 99309, NCI-2010-00975

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
questionnaire administration
exercise intervention
quality-of-life assessment quality of life assessment
survey administration
management of therapy complications complications of therapy, management of
psychosocial assessment and care psychosocial assessment

Primary Outcomes

Measure
Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program
time frame: Approximately 24 months
BMI
time frame: 6 months
Muscular strength
time frame: 6 months
Range of motion
time frame: 6 months
Quality of life
time frame: 6 months
Proportion of screened women who are eligible for the study and the proportion of eligible women who agree to participate
time frame: Approximately 24 months
Proportion of women who complete the study and the average number of weeks of participation
time frame: Approximately 24 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion - First occurrence of breast cancer - BMI >= 25 - Recently completed treatment(chemotherapy/radiation) for breast cancer (=< 8 weeks), but can be receiving adjuvant hormonal therapy - Willing to comply with study visits, as outlined in the protocol - Lives within 30 miles of study site, or willing to travel to study site if outside a 30-mile radius - Ability to participate in a moderate exercise program, such as freedom from any orthopedic abnormalities that would prevent participation - Ability to understand and the willingness to sign a written informed consent document Exclusion - Unstable angina - Cardiac conduction disturbances - Plans to move from the study area - Dementia that is medically documented or suspected - Advanced arterial disease causing ischemia of any limb - Physical immobility - Homebound for medical reasons - Dependent on wheelchair for mobility - Chronic disease which significantly reduces 4-year survival - Recurrent breast cancer

Additional Information

Official title A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer
Principal investigator Mara Vitolins
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.