nCCR for Chemotherapy Related Cognitive Impairment Randomized Study

NCT05283629 | Active Not Recruiting

• 1 other identifier: 211521
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chemo-brain; Chemotherapy-Related Cognitive Impairment

Keywords

Chemotherapy; Cognitive Impairment; neuroplasticity-based computerized cognitive remediation; nCCR

Outcome Measures

Primary Outcomes (1)

• Assess whether nCCR training produces change in subjective cognitive complaints breast cancer survivors with CRCI.

  Paired samples t-tests will be used to assess FACT-Cog PCI Scores. We hypothesize that nCCR treatment will improve FACT-Cog scores in breast cancer patients with persistent CRCI over 6 weeks of treatment compared to the education control group. The primary measure used to assess subjective cognitive performance was the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale and evaluates memory, concentration, mental acuity, verbal fluency, functional interference, and multitasking ability. At baseline and post-treatment visits, participants rated on a 5-point Likert scale how they assessed various aspects of their cognitive functioning over the last 7 days. Higher scores indicate better ratings of cognitive functioning. Higher scores indicate better ratings of cognitive functioning.

  6-weeks

Secondary Outcomes (1)

• Assess whether 6-weeks of nCCR training produces change in cognitive performance on neuropsychological measures in breast cancer survivors with CRCI.

  6-weeks

Study Arms (2)

Neuroplasticity-based Computerized Cognitive Remediation

EXPERIMENTAL

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.

Behavioral: Neuroplasticity-based Computerized Cognitive Remediation

Active Comparison Control

ACTIVE COMPARATOR

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.

Behavioral: Active Control Condition

Interventions

Neuroplasticity-based Computerized Cognitive Remediation 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.

Neuroplasticity-based Computerized Cognitive Remediation

Active Control Condition 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.

Active Comparison Control

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: collaborator
• Vanderbilt University Medical Center: collaborator
• University of Massachusetts, Worcester: lead

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Links

• Vega Lab Website

MeSH Terms

Conditions

Chemotherapy-Related Cognitive Impairment; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jennifer N Vega, PhD

  University of Massachusetts Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participants and the primary investigator are blinded to the arm of the study they receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 17, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)