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Increasing Physical Activity Among Breast Cancer Survivors With Depression

Primary Purpose

Depression, Physical Activity, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Print-based education
Fitbit
Active Living counseling
Facility Access
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical Activity Intervention

Arm Description

Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 3, 2016
Last Updated
February 21, 2019
Sponsor
University of Texas Southwestern Medical Center
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02781051
Brief Title
Increasing Physical Activity Among Breast Cancer Survivors With Depression
Official Title
Increasing Physical Activity Among Breast Cancer Survivors With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Physical Activity, Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity Intervention
Arm Type
Experimental
Arm Description
Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.
Intervention Type
Behavioral
Intervention Name(s)
Print-based education
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Fitbit
Intervention Description
Subjects will be provided with a commercially available activity monitor (i.e., Fitbit) and instructed to wear the device daily.
Intervention Type
Behavioral
Intervention Name(s)
Active Living counseling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Facility Access
Intervention Description
Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).
Primary Outcome Measure Information:
Title
Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer
Description
Assess changes in physical activity at 6 months following physical activity intervention.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR)
Description
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
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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Increasing Physical Activity Among Breast Cancer Survivors With Depression

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