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Promoting Activity in Cancer Survivors (PACES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03060941
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : January 26, 2021
Sponsor:
Collaborator:
Cancer Prevention Research Institute of Texas
Information provided by (Responsible Party):
Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center

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.

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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

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060941


Locations
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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
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Principal Investigator: Madhukar H Trivedi, MD UTSW
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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