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Breast Cancer FemaleNCT05444231

Breaking Through the Brain Fog: An Online Research Study

A study testing Brain Training A, Brain Training B and Brain Training C in people with Breast Cancer Female, run by The University of Texas at Dallas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 80 years, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
Brain Training A, Brain Training B and Brain Training C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
193 participants
Where
1 siteUnited States
Study dates
23 Aug 2023to 9 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Center for BrainHealth at the University of Texas at Dallas

    Dallas, Texas, 75235

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Brain Training A, Brain Training B, Brain Training C
Keywords
Cognitive Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brain Training ABehavioural

    Interventions may include education, exercises, and/or strategies to support brain health

  • Brain Training BBehavioural

    Interventions may include education, exercises, and/or strategies to support brain health

  • Brain Training CBehavioural

    Interventions may include education, exercises, and/or strategies to support brain health

Study groups in NCT05444231
Study groupRoleWhat they receive
Brain Training AExperimentalThis group will access one type of online brain-health oriented training.
Receives: Behavioral: Brain Training A
Brain Training BActive comparatorThis group will access a distinct type of online brain-health oriented training.
Receives: Behavioral: Brain Training B
Brain Training CActive comparatorThis group will access a distinct type of online brain-health oriented training.
Receives: Behavioral: Brain Training C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BrainHealth Index Score

    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)

    Measured: Baseline, 3 month, 6 month

Secondary outcomes (4)

  1. Functional Assessment of Cancer Therapy - Cognitive Function (FACT_Cog)

    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)

    Measured: Baseline, 3 month, 6 month

  2. Double Decision

    The investigators will assess change scores on a visual processing speed task (Min value = 0, Max value = 100) (Higher score = Better performance)

    Measured: Baseline, 3 month, 6 month

  3. Rapid Visual Information Processing

    The investigators will assess change scores on measure of selective attention (Min value = 0, Max value = 100) (Higher score = Better performance)

    Measured: Baseline, 3 month, 6 month

  4. Delayed matching to sample

    The investigators will assess change scores on measure of visual memory (Min value = 0, Max value = 100) (Higher score = Better performance)

    Measured: Baseline, 3 month, 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start23 Aug 2023
  3. Primary completion9 Mar 2025
  4. Study completion9 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05444231
Sponsor's protocol ID
24-434
Status last verified
Jun 2025
First submitted
29 Jun 2022
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chapman SB, Aslan S, Spence JS, Hart JJ Jr, Bartz EK, Didehbani N, Keebler MW, Gardner CM, Strain JF, DeFina LF, Lu H. Neural mechanisms of brain plasticity with complex cognitive training in healthy seniors. Cereb Cortex. 2015 Feb;25(2):396-405. doi: 10.1093/cercor/bht234. Epub 2013 Aug 28.

    PubMed 23985135

  • Chapman SB, Fratantoni JM, Robertson IH, D'Esposito M, Ling GSF, Zientz J, Vernon S, Venza E, Cook LG, Tate A, Spence JS. A Novel BrainHealth Index Prototype Improved by Telehealth-Delivered Training During COVID-19. Front Public Health. 2021 Mar 16;9:641754. doi: 10.3389/fpubh.2021.641754. eCollection 2021.

    PubMed 33796498

  • Chapman SB, Mudar RA. Enhancement of cognitive and neural functions through complex reasoning training: evidence from normal and clinical populations. Front Syst Neurosci. 2014 Apr 28;8:69. doi: 10.3389/fnsys.2014.00069. eCollection 2014.

    PubMed 24808834

  • Chapman SB, Aslan S, Spence JS, Keebler MW, DeFina LF, Didehbani N, Perez AM, Lu H, D'Esposito M. Distinct Brain and Behavioral Benefits from Cognitive vs. Physical Training: A Randomized Trial in Aging Adults. Front Hum Neurosci. 2016 Jul 18;10:338. doi: 10.3389/fnhum.2016.00338. eCollection 2016.

    PubMed 27462210

  • Chapman SB, Spence JS, Aslan S, Keebler MW. Enhancing Innovation and Underlying Neural Mechanisms Via Cognitive Training in Healthy Older Adults. Front Aging Neurosci. 2017 Oct 9;9:314. doi: 10.3389/fnagi.2017.00314. eCollection 2017.

    PubMed 29062276

  • Motes MA, Yezhuvath US, Aslan S, Spence JS, Rypma B, Chapman SB. Higher-order cognitive training effects on processing speed-related neural activity: a randomized trial. Neurobiol Aging. 2018 Feb;62:72-81. doi: 10.1016/j.neurobiolaging.2017.10.003. Epub 2017 Oct 12.

    PubMed 29121545

  • Han K, Davis RA, Chapman SB, Krawczyk DC. Strategy-based reasoning training modulates cortical thickness and resting-state functional connectivity in adults with chronic traumatic brain injury. Brain Behav. 2017 Apr 10;7(5):e00687. doi: 10.1002/brb3.687. eCollection 2017 May.

    PubMed 28523229

  • Vas A, Chapman S, Aslan S, Spence J, Keebler M, Rodriguez-Larrain G, Rodgers B, Jantz T, Martinez D, Rakic J, Krawczyk D. Reasoning training in veteran and civilian traumatic brain injury with persistent mild impairment. Neuropsychol Rehabil. 2016 Aug;26(4):502-31. doi: 10.1080/09602011.2015.1044013. Epub 2015 May 27.

    PubMed 26018041

  • Das N, Spence JS, Aslan S, Vanneste S, Mudar R, Rackley A, Quiceno M, Chapman SB. Cognitive Training and Transcranial Direct Current Stimulation in Mild Cognitive Impairment: A Randomized Pilot Trial. Front Neurosci. 2019 Apr 12;13:307. doi: 10.3389/fnins.2019.00307. eCollection 2019.

    PubMed 31031581

  • Han K, Martinez D, Chapman SB, Krawczyk DC. Neural correlates of reduced depressive symptoms following cognitive training for chronic traumatic brain injury. Hum Brain Mapp. 2018 Jul;39(7):2955-2971. doi: 10.1002/hbm.24052. Epub 2018 Mar 23.

    PubMed 29573026

  • Venza EE, Chapman SB, Aslan S, Zientz JE, Tyler DL, Spence JS. Enhancing Executive Function and Neural Health in Bipolar Disorder through Reasoning Training. Front Psychol. 2016 Nov 1;7:1676. doi: 10.3389/fpsyg.2016.01676. eCollection 2016.

    PubMed 27847486

Questions about this trial

What is this clinical trial studying?

A study testing Brain Training A, Brain Training B and Brain Training C in people with Breast Cancer Female, run by The University of Texas at Dallas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BrainHealth Index Score (time frame: Baseline, 3 month, 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05444231, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.

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