Increasing Physical Activity Among Breast Cancer Survivors With Depression

Not Applicable

Completed

• Conditions: Depression; Breast Cancer; Physical Activity
• Interventions: Behavioral: Print-based education; Device: Fitbit; Behavioral: Active Living counseling; Other: Facility Access

• Registration Number: NCT02781051
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-24
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Results First Submitted: 2018-12-03
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-21
• Last Update Submitted: 2019-02-21
• Results First Posted: 2019-02-22
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physical Activity Intervention	Print-based education	Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.
Physical Activity Intervention	Fitbit	Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.
Physical Activity Intervention	Facility Access	Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.
Physical Activity Intervention	Active Living counseling	Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.

Primary Outcome Measures

Name	Time	Method
Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer	6 months	Assess changes in physical activity at 6 months following physical activity intervention.

Secondary Outcome Measures

Name	Time	Method
Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR)	6 months	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

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States