Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
Conditions
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.
Interventions
OTHERquestionnaire administration
BEHAVIORALexercise intervention
PROCEDUREquality-of-life assessment
OTHERsurvey administration
PROCEDUREmanagement of therapy complications
PROCEDUREpsychosocial assessment and care
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program | Approximately 24 months |
| BMI | 6 months |
| Muscular strength | 6 months |
| Range of motion | 6 months |
| Quality of life | 6 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 |
Countries
United States
Outcome results
None listed