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
About this trial
This is an interventional treatment trial for Depression
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
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
NCT ID
NCT02781051
First Posted
May 3, 2016
Last Updated
February 21, 2019
Sponsor
University of Texas Southwestern Medical Center
Collaborators
American Cancer Society, Inc.
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
Learn more about this trial
Increasing Physical Activity Among Breast Cancer Survivors With Depression
We'll reach out to this number within 24 hrs