Breaking Through the Brain Fog: An Online Research Study

June 5, 2025 updated by: Sandra Chapman, PhD, The University of Texas at Dallas

Breaking Through the Brain Fog: An Online RCT for Breast Cancer Survivors

This study will investigate the benefits of distinct brain health trainings in breast cancer survivors (age 30-80) with cognitive concerns post-chemotherapy. This study can be completed from the comfort of participant's own home.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will complete online assessments at 3 timepoints over 6 months (Month 0, 3, 6). During the first 3 months of the study, participants will be randomized into one of three online training programs to support cognitive function; training will end after the first 3 months. The third online assessment (Month 6) will measure maintained gains since ending training. Participants will not be aware of the interventions assigned to other participants. Participants may be reimbursed for their time.

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • The Center for BrainHealth at The University of Texas at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Female breast cancer survivors who...

  • are between ages of 30-80
  • were diagnosed with Stage I-III
  • received chemotherapy
  • completed chemotherapy at least 6 months ago but not more than 5 years
  • endorse changes in thinking since end of chemotherapy treatment
  • have working internet and a device
  • consider themselves fluent in English

Exclusion criteria:

  • Males
  • A re-occurrence of breast cancer or a diagnosis of another
  • An uncorrected hearing or vision issue that would hinder ability to read and/or listen to training material
  • Participation in a cognitive training program in the last 12 months.
  • A reported substance abuse problem
  • Diagnosis of a neurodegenerative disease or psychotic disorder
  • History of stroke, concussion, or brain injury since completing chemotherapy
  • Inability to function independently due to Autism Spectrum Disorder diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brain Training A
This group will access one type of online brain-health oriented training.
Behavioral: Brain Training A
Interventions may include education, exercises, and/or strategies to support brain health
Active Comparator: Brain Training B
This group will access a distinct type of online brain-health oriented training.
Behavioral: Brain Training B
Interventions may include education, exercises, and/or strategies to support brain health
Active Comparator: Brain Training C
This group will access a distinct type of online brain-health oriented training.
Behavioral: Brain Training C
Interventions may include education, exercises, and/or strategies to support brain health

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BrainHealth Index Score
Time Frame: Baseline, 3 month, 6 month
The investigators will assess change on a holistic measure of cognitive, social, well-being, and daily life health on the BrainHealth Index across multiple timepoints. (Min value = 16, Max value = 1032) (Higher score = Better outcome)
Baseline, 3 month, 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy - Cognitive Function (FACT_Cog)
Time Frame: Baseline, 3 month, 6 month
The investigators will assess change in self-reported cognitive deficits following an online training program. (Min value = 0, Max value = 148) (Higher score = better outcome)
Baseline, 3 month, 6 month
Double Decision
Time Frame: Baseline, 3 month, 6 month
The investigators will assess change scores on a visual processing speed task (Min value = 0, Max value = 100) (Higher score = Better performance)
Baseline, 3 month, 6 month
Rapid Visual Information Processing
Time Frame: Baseline, 3 month, 6 month
The investigators will assess change scores on measure of selective attention (Min value = 0, Max value = 100) (Higher score = Better performance)
Baseline, 3 month, 6 month
Delayed matching to sample
Time Frame: Baseline, 3 month, 6 month
The investigators will assess change scores on measure of visual memory (Min value = 0, Max value = 100) (Higher score = Better performance)
Baseline, 3 month, 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas at Dallas

Investigators

  • Principal Investigator: Sandra B Chapman, PhD, Center for BrainHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2023

Primary Completion (Actual)

March 9, 2025

Study Completion (Actual)

March 9, 2025

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

June 29, 2022

First Posted (Actual)

July 5, 2022

Study Record Updates

Last Update Posted (Actual)

June 6, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-434

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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