Promoting Activity in Cancer Survivors
PACES
1 other identifier
interventional
355
1 country
1
Brief Summary
A randomized multi-component physical activity intervention for breast cancer survivors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
December 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedJanuary 26, 2021
January 1, 2021
2.2 years
February 17, 2017
January 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Moderate-to-vigorous physical activity measured by Actigraph accelerometer
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
Study Arms (16)
Group 1
EXPERIMENTALPhysical activity education
Group 2
EXPERIMENTALPhysical activity education and facility access
Group 3
EXPERIMENTALPhysical activity education and supervised exercise sessions
Group 4
EXPERIMENTALPhysical activity education and self-monitoring (Fitbit)
Group 5
EXPERIMENTALPhysical activity education and active living counseling
Group 6
EXPERIMENTALPhysical activity education, facility access, and supervised exercise sessions
Group 7
EXPERIMENTALPhysical activity education, facility access, and self-monitoring (Fitbit)
Group 8
EXPERIMENTALPhysical activity education, facility access, and active living counseling
Group 9
EXPERIMENTALPhysical activity education, supervised exercise sessions, and self-monitoring (Fitbit)
Group 10
EXPERIMENTALPhysical activity education, supervised exercise sessions, and active living counseling
Group 11
EXPERIMENTALPhysical activity education, self-monitoring (Fitbit), and active living counseling
Group 12
EXPERIMENTALPhysical activity education, facility access, supervised exercise sessions, and self-monitoring (Fitbit)
Group 13
EXPERIMENTALPhysical activity education, facility access, supervised exercise sessions, and active living counseling
Group 14
EXPERIMENTALPhysical activity education, facility access, self-monitoring (Fitbit), and active living counseling
Group 15
EXPERIMENTALPhysical activity education, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling
Group 16
EXPERIMENTALPhysical activity education, facility access, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- medical condition contraindicating physical activity participation
- cognitively unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern Medical Center
Dallas, Texas, 75235, United States
Related Publications (2)
Rethorst CD, Carmody TJ, Argenbright KE, Mayes TL, Hamann HA, Trivedi MH. Considering depression as a secondary outcome in the optimization of physical activity interventions for breast cancer survivors in the PACES trial: a factorial randomized controlled trial. Int J Behav Nutr Phys Act. 2023 Apr 20;20(1):47. doi: 10.1186/s12966-023-01437-x.
PMID: 37081460DERIVEDRethorst CD, Hamann HA, Carmody TJ, Sharp KJ, Argenbright KE, Haley BB, Skinner CS, Trivedi MH. The Promoting Activity in Cancer Survivors (PACES) trial: a multiphase optimization of strategy approach to increasing physical activity in breast cancer survivors. BMC Cancer. 2018 Jul 18;18(1):744. doi: 10.1186/s12885-018-4662-5.
PMID: 30021554DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Madhukar H Trivedi, MD
UTSW
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PROFESSOR
Study Record Dates
First Submitted
February 17, 2017
First Posted
February 23, 2017
Study Start
December 4, 2017
Primary Completion
February 28, 2020
Study Completion
February 28, 2020
Last Updated
January 26, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share