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Breaking Through the Brain Fog: An Online Research Study

Primary Purpose

Breast Cancer Female

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brain Training A
Brain Training B
Brain Training C
Sponsored by
The University of Texas at Dallas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer Female focused on measuring Cognitive Intervention

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female
  • English-speaking
  • Ages 28-80
  • Diagnosed Stages l to lll
  • If underwent chemotherapy, it was within past 6 months-5 years
  • Internet and device with audio/video capability

Exclusion Criteria:

  • Males
  • Individuals who may have an uncorrected hearing or vision issue that would hinder their ability to read and/or listen to training material
  • Individuals that have one any of the following at onset of study, as determined by a self- report screening form:
  • Diagnosed neurodegenerative disease
  • History of stroke, concussion, or brain injury that currently hinders you from functioning at your prior level
  • Diagnosed with Autism Spectrum Disorder and not functioning independently

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Brain Training A

Brain Training B

Brain Training C

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

BrainHealth Index Score
We will assess change on a holistic measure of cognitive, social, well-being, and daily life health on the BrainHealth Index (BHI) across multiple timepoints. Higher score = Better outcome

Secondary Outcome Measures

Functional Assessment of Cancer Therapy - Cognitive Function (FACT_Cog)
We will assess change in self-reported cognitive deficits following an online training program. (Higher score = better outcome)

Full Information

First Posted
June 29, 2022
Last Updated
July 27, 2023
Sponsor
The University of Texas at Dallas
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1. Study Identification

Unique Protocol Identification Number
NCT05444231
Brief Title
Breaking Through the Brain Fog: An Online Research Study
Official Title
Breaking Through the Brain Fog: An Online Study for Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas at Dallas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 your own home.
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. Group assignment will not be disclosed until study is completed. Participants may be reimbursed for their time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
Keywords
Cognitive Intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brain Training A
Arm Type
Experimental
Arm Description
This group will access one type of online brain-health oriented training.
Arm Title
Brain Training B
Arm Type
Active Comparator
Arm Description
This group will access a distinct type of online brain-health oriented training.
Arm Title
Brain Training C
Arm Type
Active Comparator
Arm Description
This group will access a distinct type of online brain-health oriented training.
Intervention Type
Behavioral
Intervention Name(s)
Brain Training A
Intervention Description
Interventions may include education, exercises, and/or strategies to support brain health
Intervention Type
Behavioral
Intervention Name(s)
Brain Training B
Intervention Description
Interventions may include education, exercises, and/or strategies to support brain health
Intervention Type
Behavioral
Intervention Name(s)
Brain Training C
Intervention Description
Interventions may include education, exercises, and/or strategies to support brain health
Primary Outcome Measure Information:
Title
BrainHealth Index Score
Description
We will assess change on a holistic measure of cognitive, social, well-being, and daily life health on the BrainHealth Index (BHI) across multiple timepoints. Higher score = Better outcome
Time Frame
Baseline, 3 month, 6 month
Secondary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy - Cognitive Function (FACT_Cog)
Description
We will assess change in self-reported cognitive deficits following an online training program. (Higher score = better outcome)
Time Frame
Baseline, 3 month, 6 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin E Venza, MS
Phone
972-883-3208
Email
erin.venza@utdallas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra B Chapman, PhD
Organizational Affiliation
Center for BrainHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for BrainHealth at the University of Texas at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Venza
Phone
972-883-3208
Email
erin.venza@utdallas.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23985135
Citation
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.
Results Reference
background
PubMed Identifier
33796498
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.
Results Reference
background
PubMed Identifier
24808834
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.
Results Reference
background
PubMed Identifier
27462210
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.
Results Reference
background
PubMed Identifier
29062276
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.
Results Reference
background
PubMed Identifier
29121545
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.
Results Reference
background
PubMed Identifier
28523229
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.
Results Reference
background
PubMed Identifier
26018041
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.
Results Reference
background
PubMed Identifier
31031581
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.
Results Reference
background
PubMed Identifier
29573026
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.
Results Reference
background
PubMed Identifier
27847486
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.
Results Reference
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Breaking Through the Brain Fog: An Online Research Study

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