Promoting Activity in Cancer Survivors

Not Applicable

Completed

• Conditions: Physical Activity; Breast Cancer

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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