Increasing Physical Activity Among Breast Cancer Survivors With Depression

February 21, 2019 updated by: University of Texas Southwestern Medical Center
Pilot study to assess a multi-component intervention to increase physical activity among breast cancer survivors with depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical Activity Intervention
Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.
Behavioral: Print-based education
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.
Device: Fitbit
Subjects will be provided with a commercially available activity monitor (i.e., Fitbit) and instructed to wear the device daily.
Behavioral: Active Living counseling
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.
Other: Facility Access
Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

American Cancer Society, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 24, 2016

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 122015-072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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