Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors
NCT ID: NCT01113554
Last Updated: 2018-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2010-06-30
2012-11-30
Brief Summary
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PURPOSE: This clinical trial studies a breast cancer rehabilitation program in improving quality of life in breast cancer survivors.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
questionnaire administration
exercise intervention
quality-of-life assessment
survey administration
management of therapy complications
psychosocial assessment and care
Interventions
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questionnaire administration
exercise intervention
quality-of-life assessment
survey administration
management of therapy complications
psychosocial assessment and care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Mara Vitolins
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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NCI-2010-00975
Identifier Type: -
Identifier Source: secondary_id
CCCWFU 99309
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00012783
Identifier Type: -
Identifier Source: org_study_id
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