Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Stage IIIA Breast Cancer; Stage IV Breast Cancer; Stage I Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage II Breast Cancer
• Interventions: Other: questionnaire administration; Behavioral: exercise intervention; Procedure: quality-of-life assessment; Other: survey administration; Procedure: management of therapy complications; Procedure: psychosocial assessment and care

• Registration Number: NCT01113554
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2010-04-28
• Study First Submitted QC: 2010-04-29
• Study First Posted: 2010-04-30
• Study Start: 2010-06
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	exercise intervention	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.
Arm I	questionnaire administration	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.
Arm I	quality-of-life assessment	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.
Arm I	survey administration	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.
Arm I	management of therapy complications	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.
Arm I	psychosocial assessment and care	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States