Promoting Activity in Cancer Survivors

Not Applicable

Completed

• Conditions: Physical Activity; Breast Cancer
• Interventions: Behavioral: Physical activity education; Behavioral: Facility access; Behavioral: Supervised exercise sessions; Behavioral: Self-monitoring (Fitbit); Behavioral: Active living counseling

• Registration Number: NCT03060941
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-23
• Study Start: 2017-12-04
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-23
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 355

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

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Exclusion Criteria

• medical condition contraindicating physical activity participation
• cognitively unable to give informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Physical activity education	Physical activity education
Group 4	Physical activity education	Physical activity education and self-monitoring (Fitbit)
Group 7	Self-monitoring (Fitbit)	Physical activity education, facility access, and self-monitoring (Fitbit)
Group 4	Self-monitoring (Fitbit)	Physical activity education and self-monitoring (Fitbit)
Group 6	Facility access	Physical activity education, facility access, and supervised exercise sessions
Group 3	Supervised exercise sessions	Physical activity education and supervised exercise sessions
Group 5	Physical activity education	Physical activity education and active living counseling
Group 6	Physical activity education	Physical activity education, facility access, and supervised exercise sessions
Group 6	Supervised exercise sessions	Physical activity education, facility access, and supervised exercise sessions
Group 7	Physical activity education	Physical activity education, facility access, and self-monitoring (Fitbit)
Group 7	Facility access	Physical activity education, facility access, and self-monitoring (Fitbit)
Group 3	Physical activity education	Physical activity education and supervised exercise sessions
Group 10	Supervised exercise sessions	Physical activity education, supervised exercise sessions, and active living counseling
Group 11	Active living counseling	Physical activity education, self-monitoring (Fitbit), and active living counseling
Group 13	Active living counseling	Physical activity education, facility access, supervised exercise sessions, and active living counseling
Group 15	Supervised exercise sessions	Physical activity education, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling
Group 16	Supervised exercise sessions	Physical activity education, facility access, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling
Group 2	Physical activity education	Physical activity education and facility access
Group 2	Facility access	Physical activity education and facility access
Group 5	Active living counseling	Physical activity education and active living counseling
Group 8	Physical activity education	Physical activity education, facility access, and active living counseling
Group 9	Physical activity education	Physical activity education, supervised exercise sessions, and self-monitoring (Fitbit)
Group 10	Physical activity education	Physical activity education, supervised exercise sessions, and active living counseling
Group 11	Self-monitoring (Fitbit)	Physical activity education, self-monitoring (Fitbit), and active living counseling
Group 8	Facility access	Physical activity education, facility access, and active living counseling
Group 14	Active living counseling	Physical activity education, facility access, self-monitoring (Fitbit), and active living counseling
Group 16	Facility access	Physical activity education, facility access, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling
Group 8	Active living counseling	Physical activity education, facility access, and active living counseling
Group 9	Supervised exercise sessions	Physical activity education, supervised exercise sessions, and self-monitoring (Fitbit)
Group 11	Physical activity education	Physical activity education, self-monitoring (Fitbit), and active living counseling
Group 12	Facility access	Physical activity education, facility access, supervised exercise sessions, and self-monitoring (Fitbit)
Group 12	Supervised exercise sessions	Physical activity education, facility access, supervised exercise sessions, and self-monitoring (Fitbit)
Group 14	Physical activity education	Physical activity education, facility access, self-monitoring (Fitbit), and active living counseling
Group 15	Self-monitoring (Fitbit)	Physical activity education, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling
Group 9	Self-monitoring (Fitbit)	Physical activity education, supervised exercise sessions, and self-monitoring (Fitbit)
Group 10	Active living counseling	Physical activity education, supervised exercise sessions, and active living counseling
Group 12	Physical activity education	Physical activity education, facility access, supervised exercise sessions, and self-monitoring (Fitbit)
Group 12	Self-monitoring (Fitbit)	Physical activity education, facility access, supervised exercise sessions, and self-monitoring (Fitbit)
Group 14	Self-monitoring (Fitbit)	Physical activity education, facility access, self-monitoring (Fitbit), and active living counseling
Group 16	Self-monitoring (Fitbit)	Physical activity education, facility access, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling
Group 13	Physical activity education	Physical activity education, facility access, supervised exercise sessions, and active living counseling
Group 13	Facility access	Physical activity education, facility access, supervised exercise sessions, and active living counseling
Group 13	Supervised exercise sessions	Physical activity education, facility access, supervised exercise sessions, and active living counseling
Group 14	Facility access	Physical activity education, facility access, self-monitoring (Fitbit), and active living counseling
Group 15	Physical activity education	Physical activity education, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling
Group 15	Active living counseling	Physical activity education, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling
Group 16	Physical activity education	Physical activity education, facility access, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling
Group 16	Active living counseling	Physical activity education, facility access, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling

Primary Outcome Measures

Name	Time	Method
Moderate-to-vigorous physical activity measured by Actigraph accelerometer	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.

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States