Breaking Through the Brain Fog: An Online Research Study

NCT ID: NCT05444231

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-23

Study Completion Date

2025-03-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Brain Training A

This group will access one type of online brain-health oriented training.

Group Type EXPERIMENTAL

Brain Training A

Intervention Type BEHAVIORAL

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

Brain Training B

This group will access a distinct type of online brain-health oriented training.

Group Type ACTIVE_COMPARATOR

Brain Training B

Intervention Type BEHAVIORAL

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

Brain Training C

This group will access a distinct type of online brain-health oriented training.

Group Type ACTIVE_COMPARATOR

Brain Training C

Intervention Type BEHAVIORAL

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

Interventions

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Brain Training A

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

Intervention Type BEHAVIORAL

Brain Training B

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

Intervention Type BEHAVIORAL

Brain Training C

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas at Dallas

OTHER

Sponsor Role lead

Responsible Party

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Sandra Chapman, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandra B Chapman, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for BrainHealth

Locations

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The Center for BrainHealth at the University of Texas at Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23985135 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33796498 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24808834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27462210 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29062276 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29121545 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28523229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26018041 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31031581 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29573026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27847486 (View on PubMed)

Other Identifiers

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24-434

Identifier Type: -

Identifier Source: org_study_id

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