Breaking Through the Brain Fog: An Online Research Study

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05444231
• Other study ID #: 24-434
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2024
• Source: The University of Texas at Dallas
• Contact: Erin E Venza, MS
• Phone: 972-883-3208
• Email: erin.venza[@]utdallas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Mental Fatigue

Intervention

Behavioral:
• Brain Training A
Interventions may include education, exercises, and/or strategies to support brain health
• Brain Training B
Interventions may include education, exercises, and/or strategies to support brain health
• Brain Training C
Interventions may include education, exercises, and/or strategies to support brain health

Locations

Country	Name	City	State
United States	The Center for BrainHealth at the University of Texas at Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas at Dallas

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline, 3 month, 6 month
Secondary	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)	Baseline, 3 month, 6 month
Secondary	Double Decision	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
Secondary	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)	Baseline, 3 month, 6 month
Secondary	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)	Baseline, 3 month, 6 month