Promoting Activity in Cancer Survivors (PACES)

• ClinicalTrials.gov Identifier: NCT03060941
• Recruitment Status: Completed
• First Posted: February 23, 2017
• Last Update Posted: January 26, 2021
• Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Cancer Prevention Research Institute of Texas
• Information provided by (Responsible Party): Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center

Study Description

Brief Summary:

A randomized multi-component physical activity intervention for breast cancer survivors.

Condition or disease	Intervention/treatment	Phase
Physical Activity; Breast Cancer	Behavioral: Physical activity education; Behavioral: Facility access; Behavioral: Supervised exercise sessions; Behavioral: Self-monitoring (Fitbit); Behavioral: Active living counseling	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 355 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The 500 participants in the physical activity intervention will be randomly assigned to one of sixteen intervention groups (see Table below). Randomization will be stratified by clinical site. The randomization scheme will be conducted by the study statistician. The randomization scheme will consist of balanced blocks within each stratum, with block size will be varied and randomly permuted. Allocation will occur following completion of baseline assessments.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Promoting Activity in Cancer Survivors
• Actual Study Start Date: December 4, 2017
• Actual Primary Completion Date: February 28, 2020
• Actual Study Completion Date: February 28, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1; Physical activity education	Behavioral: 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	Behavioral: Physical activity education; Participants will be given educational materials on how to increase physical activity levels.; Behavioral: Facility access; Participants will receive at 6 month membership to a local fitness facility.
Experimental: Group 3; Physical activity education and supervised exercise sessions	Behavioral: Physical activity education; Participants will be given educational materials on how to increase physical activity levels.; Behavioral: Supervised exercise sessions; Participants will attend weekly supervised exercise sessions with an exercise interventionist.
Experimental: Group 4; Physical activity education and self-monitoring (Fitbit)	Behavioral: Physical activity education; Participants will be given educational materials on how to increase physical activity levels.; Behavioral: Self-monitoring (Fitbit); Participants will be given a Fitbit to monitor their physical activity levels.
Experimental: Group 5; Physical activity education and active living counseling	Behavioral: Physical activity education; Participants will be given educational materials on how to increase physical activity levels.; Behavioral: Active living counseling; 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	Behavioral: Physical activity education; Participants will be given educational materials on how to increase physical activity levels.; Behavioral: Facility access; Participants will receive at 6 month membership to a local fitness facility.; Behavioral: Supervised exercise sessions; Participants will attend weekly supervised exercise sessions with an exercise interventionist.
Experimental: Group 7; Physical activity education, facility access, and self-monitoring (Fitbit)	Behavioral: Physical activity education; Participants will be given educational materials on how to increase physical activity levels.; Behavioral: Facility access; Participants will receive at 6 month membership to a local fitness facility.; Behavioral: Self-monitoring (Fitbit); Participants will be given a Fitbit to monitor their physical activity levels.
Experimental: Group 8; Physical activity education, facility access, and active living counseling	Behavioral: Physical activity education; Participants will be given educational materials on how to increase physical activity levels.; Behavioral: Facility access; Participants will receive at 6 month membership to a local fitness facility.; Behavioral: Active living counseling; 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)	Behavioral: Physical activity education; Participants will be given educational materials on how to increase physical activity levels.; Behavioral: Supervised exercise sessions; Participants will attend weekly supervised exercise sessions with an exercise interventionist.; Behavioral: Self-monitoring (Fitbit); 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	Behavioral: Physical activity education; Participants will be given educational materials on how to increase physical activity levels.; Behavioral: Supervised exercise sessions; Participants will attend weekly supervised exercise sessions with an exercise interventionist.; Behavioral: Active living counseling; 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	Behavioral: Physical activity education; Participants will be given educational materials on how to increase physical activity levels.; Behavioral: Self-monitoring (Fitbit); Participants will be given a Fitbit to monitor their physical activity levels.; Behavioral: Active living counseling; 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)	Behavioral: Physical activity education; Participants will be given educational materials on how to increase physical activity levels.; Behavioral: Facility access; Participants will receive at 6 month membership to a local fitness facility.; Behavioral: Supervised exercise sessions; Participants will attend weekly supervised exercise sessions with an exercise interventionist.; Behavioral: Self-monitoring (Fitbit); 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	Behavioral: Physical activity education; Participants will be given educational materials on how to increase physical activity levels.; Behavioral: Facility access; Participants will receive at 6 month membership to a local fitness facility.; Behavioral: Supervised exercise sessions; Participants will attend weekly supervised exercise sessions with an exercise interventionist.; Behavioral: Active living counseling; 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	Behavioral: Physical activity education; Participants will be given educational materials on how to increase physical activity levels.; Behavioral: Facility access; Participants will receive at 6 month membership to a local fitness facility.; Behavioral: Self-monitoring (Fitbit); Participants will be given a Fitbit to monitor their physical activity levels.; Behavioral: Active living counseling; 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	Behavioral: Physical activity education; Participants will be given educational materials on how to increase physical activity levels.; Behavioral: Supervised exercise sessions; Participants will attend weekly supervised exercise sessions with an exercise interventionist.; Behavioral: Self-monitoring (Fitbit); Participants will be given a Fitbit to monitor their physical activity levels.; Behavioral: Active living counseling; 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	Behavioral: Physical activity education; Participants will be given educational materials on how to increase physical activity levels.; Behavioral: Facility access; Participants will receive at 6 month membership to a local fitness facility.; Behavioral: Supervised exercise sessions; Participants will attend weekly supervised exercise sessions with an exercise interventionist.; Behavioral: Self-monitoring (Fitbit); Participants will be given a Fitbit to monitor their physical activity levels.; Behavioral: Active living counseling; Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Texas

UT Southwestern Medical Center

Dallas, Texas, United States, 75235

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Cancer Prevention Research Institute of Texas

Investigators

• Principal Investigator: Madhukar H Trivedi, MD; UTSW

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rethorst 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.

• Responsible Party: Madhukar H. Trivedi, MD, PROFESSOR, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT03060941
• Other Study ID Numbers: STU 092016-004
• First Posted: February 23, 2017
• Last Update Posted: January 26, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No