nCCR for Chemotherapy Related Cognitive Impairment Randomized Study

NCT ID: NCT05283629

Last Updated: 2026-01-08

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2030-03-01

Brief Summary

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The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI).

Detailed Description

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Successes in breast cancer treatment are resulting in a growing number of cancer survivors. This has broadened the scope of care from treating the disease alone to improving the quality of life of cancer survivors. Chemotherapy-related cognitive impairment (CRCI), often referred to by patients as 'chemobrain,' is a common and highly distressful side effect of chemotherapy often reported by breast cancer survivors. Managing the symptoms of CRCI should be integrated with routine cancer care as these symptoms diminish quality of life, impair work performance, and make it more difficult for patients to follow treatment regimens. CRCI can persist for months to years following cancer treatment. However, there are currently no established treatments for CRCI.

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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Chemo-brain Chemotherapy-Related Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Both participants and the primary investigator are blinded to the arm of the study they receive.

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.

Group Type EXPERIMENTAL

Neuroplasticity-based Computerized Cognitive Remediation

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Active Control Condition

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

All participants will:

* 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

Participants will be excluded for

* 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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Vega

Primary Investigator

Responsibility Role PRINCIPAL_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

Site Status

Countries

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United States

Related Links

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Other Identifiers

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211521

Identifier Type: -

Identifier Source: org_study_id

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