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Clinical Trials/NCT04049695
NCT04049695
Active, not recruiting
Not Applicable

A Randomized Trial of Physical Activity for Cognitive Functioning in Breast Cancer Survivors

University of California, San Diego1 site in 1 country253 target enrollmentSeptember 9, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Survivors
Sponsor
University of California, San Diego
Enrollment
253
Locations
1
Primary Endpoint
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.

Detailed Description

Many breast cancer survivors experience problems with mental abilities such as memory, attention, and concentration (known as cognition). Increasing physical activity has been shown to improve cognition in adults; however, little is known about whether this is helpful for cancer survivors as well. This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.

Registry
clinicaltrials.gov
Start Date
September 9, 2019
End Date
February 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sheri Hartman

Assistant Professor

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

  • breast cancer survivors who have completed active treatment at least 6 months prior to enrollment and are within 5 years of diagnosis of stage 1, 2, or 3 breast cancer
  • self-report difficulties with cognition since their cancer diagnosis
  • self-report low levels of moderate to vigorous physical activity
  • have a Fitbit compatible device with internet
  • breast cancer was treated with chemotherapy and/or hormonal therapy

Exclusion Criteria

  • medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention
  • currently taking tamoxifen or aromatase inhibitor that will be stopped in the next 6 months
  • unable to commit to a 12-month study

Outcomes

Primary Outcomes

National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test

Time Frame: Baseline to 6 months

Measure of processing speed

Secondary Outcomes

  • Patient Reported Outcomes Measurement Information System (PROMIS) cognitive abilities(Baseline to 6 months and Baseline to 12 months)
  • National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test(Baseline to 12 months)

Study Sites (1)

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