Promoting Activity in Cancer Survivors (PACES)
January 23, 2021 updated by: Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
A randomized multi-component physical activity intervention for breast cancer survivors.
Study Overview
Status
Completed
Conditions
Detailed Description
The research project is a study to assess the effects of a multi-component intervention in increasing physical activity among breast cancer survivors.
Individuals meeting inclusion/exclusion criteria will be randomized to one of sixteen intervention groups for the 6 months.
Intervention components will include print-based education, self-monitoring, Active Living counseling, supervised exercise sessions, 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 13 and 25).
Changes in physical activity will be assessed for each intervention group.
Study Type
Interventional
Enrollment (Actual)
355
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75235
- UT Southwestern Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- breast cancer survivors between 3 months and 5 years post-treatment
- report <150 minutes of moderate-to-vigorous physical activity (MVPA) on the GPAQ
- physically able to engage in physical activity
Exclusion Criteria:
- medical condition contraindicating physical activity participation
- cognitively unable to give informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Physical activity education
|
Participants will be given educational materials on how to increase physical activity levels.
|
|
Experimental: Group 2
Physical activity education and facility access
|
Participants will be given educational materials on how to increase physical activity levels.
Participants will receive at 6 month membership to a local fitness facility.
|
|
Experimental: Group 3
Physical activity education and supervised exercise sessions
|
Participants will be given educational materials on how to increase physical activity levels.
Participants will attend weekly supervised exercise sessions with an exercise interventionist.
|
|
Experimental: Group 4
Physical activity education and self-monitoring (Fitbit)
|
Participants will be given educational materials on how to increase physical activity levels.
Participants will be given a Fitbit to monitor their physical activity levels.
|
|
Experimental: Group 5
Physical activity education and active living counseling
|
Participants will be given educational materials on how to increase physical activity levels.
Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.
|
|
Experimental: Group 6
Physical activity education, facility access, and supervised exercise sessions
|
Participants will be given educational materials on how to increase physical activity levels.
Participants will receive at 6 month membership to a local fitness facility.
Participants will attend weekly supervised exercise sessions with an exercise interventionist.
|
|
Experimental: Group 7
Physical activity education, facility access, and self-monitoring (Fitbit)
|
Participants will be given educational materials on how to increase physical activity levels.
Participants will receive at 6 month membership to a local fitness facility.
Participants will be given a Fitbit to monitor their physical activity levels.
|
|
Experimental: Group 8
Physical activity education, facility access, and active living counseling
|
Participants will be given educational materials on how to increase physical activity levels.
Participants will receive at 6 month membership to a local fitness facility.
Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.
|
|
Experimental: Group 9
Physical activity education, supervised exercise sessions, and self-monitoring (Fitbit)
|
Participants will be given educational materials on how to increase physical activity levels.
Participants will attend weekly supervised exercise sessions with an exercise interventionist.
Participants will be given a Fitbit to monitor their physical activity levels.
|
|
Experimental: Group 10
Physical activity education, supervised exercise sessions, and active living counseling
|
Participants will be given educational materials on how to increase physical activity levels.
Participants will attend weekly supervised exercise sessions with an exercise interventionist.
Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.
|
|
Experimental: Group 11
Physical activity education, self-monitoring (Fitbit), and active living counseling
|
Participants will be given educational materials on how to increase physical activity levels.
Participants will be given a Fitbit to monitor their physical activity levels.
Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.
|
|
Experimental: Group 12
Physical activity education, facility access, supervised exercise sessions, and self-monitoring (Fitbit)
|
Participants will be given educational materials on how to increase physical activity levels.
Participants will receive at 6 month membership to a local fitness facility.
Participants will attend weekly supervised exercise sessions with an exercise interventionist.
Participants will be given a Fitbit to monitor their physical activity levels.
|
|
Experimental: Group 13
Physical activity education, facility access, supervised exercise sessions, and active living counseling
|
Participants will be given educational materials on how to increase physical activity levels.
Participants will receive at 6 month membership to a local fitness facility.
Participants will attend weekly supervised exercise sessions with an exercise interventionist.
Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.
|
|
Experimental: Group 14
Physical activity education, facility access, self-monitoring (Fitbit), and active living counseling
|
Participants will be given educational materials on how to increase physical activity levels.
Participants will receive at 6 month membership to a local fitness facility.
Participants will be given a Fitbit to monitor their physical activity levels.
Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.
|
|
Experimental: Group 15
Physical activity education, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling
|
Participants will be given educational materials on how to increase physical activity levels.
Participants will attend weekly supervised exercise sessions with an exercise interventionist.
Participants will be given a Fitbit to monitor their physical activity levels.
Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.
|
|
Experimental: Group 16
Physical activity education, facility access, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling
|
Participants will be given educational materials on how to increase physical activity levels.
Participants will receive at 6 month membership to a local fitness facility.
Participants will attend weekly supervised exercise sessions with an exercise interventionist.
Participants will be given a Fitbit to monitor their physical activity levels.
Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Moderate-to-vigorous physical activity measured by Actigraph accelerometer
Time Frame: 24 weeks
|
Measure physical activity at baseline and follow-up periods (3- and 6-months post-baseline) and assess percentage of survivors meeting physical activity guideline recommendations.
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Madhukar H Trivedi, MD, UTSW
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 4, 2017
Primary Completion (Actual)
February 28, 2020
Study Completion (Actual)
February 28, 2020
Study Registration Dates
First Submitted
February 17, 2017
First Submitted That Met QC Criteria
February 17, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
January 26, 2021
Last Update Submitted That Met QC Criteria
January 23, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- STU 092016-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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