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| Sponsor: | Comprehensive Cancer Center of Wake Forest University |
|---|---|
| Information provided by (Responsible Party): | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01113554 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer |
Other: questionnaire administration Behavioral: exercise intervention Procedure: quality-of-life assessment Other: survey administration Procedure: management of therapy complications Procedure: psychosocial assessment and care |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer |
| Estimated Enrollment: | 25 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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.
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Other: questionnaire administration
Behavioral: exercise intervention
Procedure: quality-of-life assessment
Other Name: quality of life assessment
Other: survey administration
Procedure: management of therapy complications
Other Name: complications of therapy, management of
Procedure: psychosocial assessment and care
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion
Exclusion
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Mara Vitolins 336-716-2886 mvitolin@wfubmc.edu | |
| Principal Investigator: Mara Vitolins | |
| Principal Investigator: | Mara Vitolins | Wake Forest University |
More Information
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01113554 History of Changes |
| Other Study ID Numbers: | CCCWFU 99309, NCI-2010-00975 |
| Study First Received: | April 28, 2010 |
| Last Updated: | April 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |