Physical Activity Intervention to Reduce Functional Health Disparities Among Breast Cancer Survivors
Study Details
Study Description
Brief Summary
The purpose of this research study is to determine whether a physical activity (exercise) program in the community will improve the functional and overall health status of older women with a history of breast cancer. The physical activity or exercise program is designed for all older breast cancer survivors, and in particular for African-Americans and women of lower socio-economic status, who are the least likely to engage in physical activity.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Specific Aim #1: To determine the effect of a refined and culturally-sensitive physical activity intervention on functional outcomes at 20 and 52 weeks among older Breast Cancer survivors who are within five years of treatment completion for stage I-III Breast Cancer (BCa).
Specific Aim #2: To examine whether race and socioeconomic status (SES) moderate the intervention effect on physical activity (PA) levels and functional outcomes at 20 and 52 weeks.
Specific Aim #3: To examine the effect of the PA intervention on longitudinal changes in beliefs, attitudes and preferences (KAPs) and PA levels, and the extent to which changes in these factors mediate intervention effect on functional outcomes.
Specific Aim #4: To determine the effect of the PA intervention on surrogate biomarkers associated with breast cancer prognosis and functional disability.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: Exercise Program The exercise in this study will consist of two types of exercise training: resistance training and aerobic exercise. Resistance training is like "weight lifting" to improve strength and function. Participants will complete resistance training by using resistance machines and free weights. Aerobic exercise is exercise that intends to improve the cardiopulmonary or oxygen/lung and heart systems. It is often referred to as "cardio" exercise. Treadmill walking, stationary cycling sessions, and/or other exercises will be used for aerobic exercise. Participants will be instructed in the exercise routine by physical fitness experts and trainers. |
Behavioral: Aerobic Training - Fixed Schedule
Supervised aerobic training for 40 minutes 3x/week for 20 weeks
Other Names:
Behavioral: Resistance Training - Fixed Schedule
Supervised resistance training for 20 minutes 3x/week for 20 weeks
Behavioral: Walking program
Unsupervised walking program 1-3 days/week for 52 weeks
Behavioral: Aerobic Training - Flexible Schedule
Supervised aerobic training done on the participant's own schedule for 32 weeks
Behavioral: Resistance Training - Flexible Schedule
Supervised resistance training done on the participant's own schedule for 32 weeks
|
| Active Comparator: Group 2: Support Group First 20 Weeks: Participants will take part in a structured Health Education and Support Group sessions once a week. Last 32 weeks: Participants will be encouraged to take part in any of the Support Group sessions offered regularly on their own schedule. |
Behavioral: Successful Survivorship Health Education and Support Group
Support groups will be held for one hour 3x/week for 20 weeks. Topics will include, but are not limited, to long-term side effects of treatment, stress management, coping with fear and uncertainty, body image, sexuality, and spirituality.
Other Names:
Behavioral: Flexible support groups
Participants will attend 1-3 weekly group sessions of their choosing for 32 weeks.
|
Outcome Measures
Primary Outcome Measures
- Change in physical performance scores based on the Short Physical Performance Battery (SPPB) [baseline to 20 weeks]
Change in physical performance will be ascertained using the Short Physical Performance Battery (SPPB). Summary scores range from 0-12 and higher scores denote higher physical performance.
Secondary Outcome Measures
- Change in SPPB scores [baseline to 52 weeks]
Change in physical performance will be ascertained using the Short Physical Performance Battery (SPPB). Summary scores range from 0-12 and higher scores denote higher physical performance.
- Change in Activities of daily living (ADL) score [baseline to 20 weeks]
Summary scores for ADL range from 0-14 and higher scores denote higher functional status.
- Change in Activities of daily living (ADL) score [baseline to 52 weeks]
Summary scores for ADL range from 0-14 and higher scores denote higher functional status.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pathologically confirmed breast cancer
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Stage I-III
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Patients who have completed treatment but are within five years of treatment completion (primary surgery, chemotherapy or radiation therapy), whichever was received last. Hormonal therapy and targeted therapy are allowed
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Race: African-Americans and Non-Hispanic Whites
Exclusion Criteria:
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Stage IV breast cancer
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Patients with end-stage disease, severe dementia and/or life expectancy of less than one year
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Inability to understand English as study instruments have not been validated in other languages
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Inability to provide informed consent
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High-risk patients (as defined by the American College of Sports Medicine risk-stratification schema using the American College of Sports Medicine (ACSM)/American Heart Association exercise pre-participation questionnaire) who do not receive clearance from cardiology
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Other medical or psychological conditions that would make participation unsafe or inhibit our ability to test our primary hypothesis, e.g. Parkinson's disease, severe dementia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | United States | 44106 |
| 2 | Metro Health Medical Center | Cleveland | Ohio | United States | 44109 |
| 3 | Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Case Comprehensive Cancer Center
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Cynthia Owusu, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CASE2116