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Clinical Trials/NCT02781051
NCT02781051
Completed
Not Applicable

Increasing Physical Activity Among Breast Cancer Survivors With Depression

University of Texas Southwestern Medical Center1 site in 1 country16 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Texas Southwestern Medical Center
Enrollment
16
Locations
1
Primary Endpoint
Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
September 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer

Time Frame: 6 months

Assess changes in physical activity at 6 months following physical activity intervention.

Secondary Outcomes

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

Study Sites (1)

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