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Clinical Trials/NCT03060941
NCT03060941
Completed
Not Applicable

Promoting Activity in Cancer Survivors

University of Texas Southwestern Medical Center1 site in 1 country355 target enrollmentDecember 4, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Activity
Sponsor
University of Texas Southwestern Medical Center
Enrollment
355
Locations
1
Primary Endpoint
Moderate-to-vigorous physical activity measured by Actigraph accelerometer
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 4, 2017
End Date
February 28, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Madhukar H. Trivedi, MD

PROFESSOR

University of Texas Southwestern Medical Center

Eligibility 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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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