Physical Activity Intervention to Reduce Functional Health Disparities Among Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Physical Activity Intervention to Reduce Functional Health Disparities Among Older Breast Cancer Survivors

Conditions
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Breast Cancer, Physical Activity

Intervention / Treatment
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* Behavioral: Aerobic Training - Fixed Schedule
* Behavioral: Resistance Training - Fixed Schedule
* Behavioral: Walking program
* Behavioral: Aerobic Training - Flexible Schedule
* Behavioral: Resistance Training - Flexible Schedule
* Behavioral: Successful Survivorship Health Education and Support Group
* Behavioral: Flexible support groups


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed breast cancer Stage I-III 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 Race: African-Americans and Non-Hispanic Whites Exclusion Criteria: Stage IV breast cancer Patients with end-stage disease, severe dementia and/or life expectancy of less than one year Inability to understand English as study instruments have not been validated in other languages Inability to provide informed consent 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 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Exercise Program<br>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<br>* Supervised aerobic training for 40 minutes 3x/week for 20 weeks<br>* Other names: Aerobic exercise;Behavioral: Resistance Training - Fixed Schedule<br>* Supervised resistance training for 20 minutes 3x/week for 20 weeks<br>Behavioral: Walking program<br>* Unsupervised walking program 1-3 days/week for 52 weeks<br>Behavioral: Aerobic Training - Flexible Schedule<br>* Supervised aerobic training done on the participant's own schedule for 32 weeks<br>Behavioral: Resistance Training - Flexible Schedule<br>* Supervised resistance training done on the participant's own schedule for 32 weeks<br>|
| Active Comparator: Group 2: Support Group<br>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<br>* 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.<br>* Other names: Structured Support Group;Behavioral: Flexible support groups<br>* Participants will attend 1-3 weekly group sessions of their choosing for 32 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical performance scores based on the Short Physical Performance Battery (SPPB) | 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. | baseline to 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SPPB scores | 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. | baseline to 52 weeks | 
| Change in Activities of daily living (ADL) score | Summary scores for ADL range from 0-14 and higher scores denote higher functional status. | baseline to 20 weeks | 
| Change in Activities of daily living (ADL) score | Summary scores for ADL range from 0-14 and higher scores denote higher functional status. | baseline to 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Breast Cancer, minority, African American