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Increasing Physical Activity Among Breast Cancer Survivors With Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781051
First Posted: May 24, 2016
Last Update Posted: October 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
  Purpose
Pilot study to assess a multi-component intervention to increase physical activity among breast cancer survivors with depression.

Condition Intervention
Depression Physical Activity Breast Cancer Behavioral: Print-based education Device: Fitbit Behavioral: Active Living counseling Other: Facility Access

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Increasing Physical Activity Among Breast Cancer Survivors With Depression

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Moderate-to-vigorous physical activity measured by Actigraph accelerometer [ Time Frame: 3 months and 6 months ]
    Assess changes in physical activity at 3 months and 6 months following physical activity intervention.


Secondary Outcome Measures:
  • Depressive symptoms measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR) [ Time Frame: 3 months and 6 months ]
    Assess changes in depressive symptoms at 3 months and 6 months following physical activity intervention.


Enrollment: 16
Study Start Date: May 2016
Study Completion Date: September 2017
Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.).

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781051


Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
American Cancer Society, Inc.
  More Information

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02781051     History of Changes
Other Study ID Numbers: STU 122015-072
First Submitted: May 3, 2016
First Posted: May 24, 2016
Last Update Posted: October 30, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Breast Neoplasms
Depression
Depressive Disorder
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders