Increasing Physical Activity Among Breast Cancer Survivors With Depression

NCT02781051 | Completed Results

• 1 other identifier: STU 122015-072
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot study to assess a multi-component intervention to increase physical activity among breast cancer survivors with depression.

Conditions

Depression; Physical Activity; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer

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

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (1)

Physical Activity Intervention

EXPERIMENTAL

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

Behavioral: Print-based education; Device: Fitbit; Behavioral: Active Living counseling; Other: Facility Access

Interventions

Print-based education BEHAVIORAL

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.

Physical Activity Intervention

Fitbit DEVICE

Subjects will be provided with a commercially available activity monitor (i.e., Fitbit) and instructed to wear the device daily.

Physical Activity Intervention

Active Living counseling BEHAVIORAL

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.

Physical Activity Intervention

Facility Access OTHER

Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).

Physical Activity Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Depression; Motor Activity; Breast Neoplasms

Interventions

Architectural Accessibility

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Facility Design and Construction; Architecture; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Chad Rethorst, Associate Professor
• Organization: UT Southwestern Medical Center

chad.rethorst@utsouthwestern.edu

2146480153

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 24, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 22, 2019
• Results First Posted: February 22, 2019

Record last verified: 2019-02

Locations

US (1)