Increasing Physical Activity Among Breast Cancer Survivors With Depression

NCT ID: NCT02781051

Last Updated: 2019-02-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Physical Activity Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Physical Activity Intervention

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

Group Type EXPERIMENTAL

Print-based education

Intervention Type 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.

Fitbit

Intervention Type DEVICE

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

Active Living counseling

Intervention Type 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.

Facility Access

Intervention Type 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.).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Fitbit

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

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

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.).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU 122015-072

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.