Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study

Study Overview
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Brief Summary
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Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life is a major goal of care. There is a strong body of evidence that exercise can reduce or manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base is overwhelmingly in early stage cancer patients. The purpose of this study is to see if a home-based, self-directed walking program can have similar benefits in women with an MBC diagnosis. The primary objective is to evaluate whether engagement in physical activity will reduce fatigue during active treatment for MBC (baseline to 3 months); this is the primary endpoint. Secondary objectives pertain to feasibility of recruitment and retention of study participants and measuring changes between baseline, 3 months and 6 months in additional quality of life measures. Exploratory analyses pertain to changes in p16INK4a levels and sarcopenia between baseline and 3 months. The design is a single arm intervention trial in 30 patients. Findings from this study will provide preliminary data for a grant application to test the physical activity intervention in a randomized controlled trial (RCT) in a large sample of women with metastatic breast cancer.

Official Title
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Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Behavioral: Walk with Ease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age 21 or older Metastatic breast cancer (MBC) diagnosis - Stage IV Receiving treatment regimen for MBC, but no more than 3 previous chemotherapy or biologic regimens Approval from the treating clinician to engage in moderate-intensity physical activity. Patient-assessed ability to walk and engage in moderate physical activity Proficient in English. IRB approved signed written informed consent. Willing and able to do all study requirements. Exclusion Criteria: One or more significant medical conditions or other issues that in the physician's judgment preclude participation in the walking intervention. No more than 3 prior chemotherapy regimens.

Ages Eligible for Study
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Minimum Age: 21 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br>Walk with Ease physical activity intervention | Behavioral: Walk with Ease<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in fatigue scores | Evaluate change in PROMIS Fatigue scores from baseline to 3 months | at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, chemotherapy, fatigue