nCCR for Chemotherapy Related Cognitive Impairment Randomized Study
NCT ID: NCT05283629
Last Updated: 2026-01-08
Study Results
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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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2022-08-01
2030-03-01
Brief Summary
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Detailed Description
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The most commonly reported CRCI symptoms in breast cancer survivors include problems with executive functions. Executive function is a cognitive domain involved in planning, problem-solving, organization, and time management. In order to improve executive dysfunction and quality of life in breast cancer survivors, we propose to use a new brain training program called neuroplasticity-based computerized cognitive remediation (nCCR). The term 'neuroplasticity' refers to the brain's ability to modify, change, and adapt throughout life and in response to experience. Neuroplacticity can be induced through the use of focused brain training that nCCR offers. Past work demonstrates that this neuroscience-guided brain training benefits other patient populations with similar cognitive problems and has shown preliminary success in cancer survivors in a small pilot study. If successful, this treatment could have significant benefits for large numbers of breast cancer survivors.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Neuroplasticity-based Computerized Cognitive Remediation
Behavioral: Neuroplasticity-based Computerized Cognitive Remediation Participants will engage in a computerized training program designed to support cognitive health in older adults. The program includes a variety of exercises that target basic sensory processing as well as higher-level cognitive functions. Training tasks adapt in difficulty based on individual performance and are intended to improve information processing and executive skills. Activities are delivered in a structured format and customized to participant progress.
Neuroplasticity-based Computerized Cognitive Remediation
Behavioral: Neuroplasticity-based Computerized Cognitive Remediation Participants will engage in a computerized training program designed to support cognitive health in older adults. The program includes a variety of exercises that target basic sensory processing as well as higher-level cognitive functions. Training tasks adapt in difficulty based on individual performance and are intended to improve information processing and executive skills. Activities are delivered in a structured format and customized to participant progress.
Active Comparison Control
The active control condition is a structured, learning-based program designed to match the nCCR intervention in terms of duration, computer use, audiovisual engagement, and participant contact with research staff.
Active Control Condition
The active control condition is a structured, learning-based program designed to match the nCCR intervention in terms of duration, computer use, audiovisual engagement, and participant contact with research staff.
Interventions
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Neuroplasticity-based Computerized Cognitive Remediation
Behavioral: Neuroplasticity-based Computerized Cognitive Remediation Participants will engage in a computerized training program designed to support cognitive health in older adults. The program includes a variety of exercises that target basic sensory processing as well as higher-level cognitive functions. Training tasks adapt in difficulty based on individual performance and are intended to improve information processing and executive skills. Activities are delivered in a structured format and customized to participant progress.
Active Control Condition
The active control condition is a structured, learning-based program designed to match the nCCR intervention in terms of duration, computer use, audiovisual engagement, and participant contact with research staff.
Eligibility Criteria
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Inclusion Criteria
* between 35 and 80 years of age
* have been diagnosed with noninvasive or invasive breast cancer
* have undergone treatment with systemic chemotherapy within the last 1- 8 years
* endorse persistent CRCI subjective complaints
* have no active unstable medical condition
* fluent in and able to read English.
Exclusion Criteria
* any active neurologic or untreated/non-remitted psychiatric disease, (e.g. active major depression or another major psychiatric disorder as described in DSM-5)
* clinically significant cognitive impairment identified on cognitive screening, diagnosis of mild cognitive impairment or dementia
* history of significant head trauma followed by persistent neurologic deficits
* history of alcohol or substance abuse or dependence within the past 2 years (DSM-5 criteria)
* any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
* Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening
* red-green color blindness
* Use of certain CNS active medications (e.g. antidepressants) will be permitted, provided dosing has been stable for at least 3 months.
35 Years
80 Years
ALL
No
Sponsors
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University of Utah
OTHER
Vanderbilt University Medical Center
OTHER
University of Massachusetts, Worcester
OTHER
Responsible Party
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Jennifer Vega
Primary Investigator
Principal Investigators
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Jennifer N Vega, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts Chan Medical School
Locations
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UMass Chan Medical School
Worcester, Massachusetts, United States
Countries
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Related Links
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Vega Lab Website
Other Identifiers
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211521
Identifier Type: -
Identifier Source: org_study_id
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