Increasing Physical Activity Among Breast Cancer Survivors With Depression

Study Overview
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Brief Summary
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Pilot study to assess a multi-component intervention to increase physical activity among breast cancer survivors with depression.

Detailed Description
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The research project is a pilot study to assess the effects of a multi-component intervention in increasing physical activity among breast cancer survivors with depression. Individuals meeting inclusion/exclusion criteria will be enrolled in the 12-week intervention with a 6 month follow up. Intervention components will include print-based education, self-monitoring, Active Living counseling, and facility access. Blood samples will be collected at baseline. Assessments (anxiety, stress, sleep) and sample collection will also occur at 3 time points during the intervention (Weeks 7, 13, and 25). Changes in physical activity will be assessed using Fitbits to measure weekly minutes of moderate/vigorous activity.

Official Title
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Increasing Physical Activity Among Breast Cancer Survivors With Depression

Conditions
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Depression, Physical Activity, Breast Cancer

Intervention / Treatment
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* Behavioral: Print-based education
* Device: Fitbit
* Behavioral: Active Living counseling
* Other: Facility Access


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive depression screen (PHQ-9) or current antidepressant treatment Report <150 minutes of weekly moderate-to-vigorous physical activity (MVPA) on the GPAQ Physically able to engage in physical activity Written and verbal fluency in English Exclusion Criteria: Medical condition contraindicating physical activity participation Recurrence of breast cancer Ductal carcinoma in situ (DCIS) diagnosis Cognitively unable to give informed consent Non-English speaking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Activity Intervention<br>Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up. | Behavioral: Print-based education<br>* All subjects will be given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise in breast cancer survivors; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.<br>Device: Fitbit<br>* Subjects will be provided with a commercially available activity monitor (i.e., Fitbit) and instructed to wear the device daily.<br>Behavioral: Active Living counseling<br>* The Active Living counseling program consists of 12 weekly group educational sessions, facilitated by project interventionists. These sessions will involve discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.<br>Other: Facility Access<br>* Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer | Assess changes in physical activity at 6 months following physical activity intervention. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR) | Assess changes in depressive symptoms at 6 months following physical activity intervention. Title: Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR) Scoring: ranges from 0-27, higher scores indicate more severe symptomatology | 6 months |