Promoting Activity in Cancer Survivors

Breast Cancer Clinical Trial

— PACES  

Official title:

Promoting Activity in Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060941
• Other study ID #: STU 092016-004
• Status: Completed
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: January 2021
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Physical Activity

Intervention

Behavioral:
• Physical activity education
Participants will be given educational materials on how to increase physical activity levels.
• Facility access
Participants will receive at 6 month membership to a local fitness facility.
• Supervised exercise sessions
Participants will attend weekly supervised exercise sessions with an exercise interventionist.
• Self-monitoring (Fitbit)
Participants will be given a Fitbit to monitor their physical activity levels.
• Active living counseling
Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Cancer Prevention Research Institute of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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