GYNecologic Cancer-Related COGnitive Impairment (GYNCOG)

March 20, 2026 updated by: Emma Barber, Northwestern University

A Pilot and Mixed-Methods Study of GYNecologic Cancer-Related COGnitive Impairment

The goal of this study is to test a home-based and patient-tailored cognitive training intervention among gynecologic cancer patients who have completed chemotherapy and who have experienced cancer-related cognitive impairment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gynecologic cancers are prevalent and long-term survivorship is increasing. In the United States, survivors of gynecologic cancer number over one million individuals and constitute more than 10% of all cancer survivors. Curative treatment usually involves systemic chemotherapy.

A distressing long-term side effect of cytotoxic chemotherapy is cancer-related cognitive impairment (CRCI), or "chemo brain," which has been reported to be present in up to 75% of patients and can linger for months or even decades after chemotherapy treatment. Despite increasing prevalence, patients report that CRCI has not been a focus of assessment or treatment, and the lack of understanding from providers has led to patient disempowerment. Within gynecologic oncology, CRCI is under-reported and understudied with no established effective treatment.

There is no currently established standard of care for managing CRCI in cancer survivors. However, existing literature highlights cognitive training as a promising nonpharmacological intervention. Cognitive training programs consist of structured cognitive exercises designed to target specific cognitive domains. It is postulated to engage neuroplasticity mechanisms, promote the formation of new neural connections, enhance cognitive reserve, and subsequently improve cognitive function and mitigate impairment. Clinically, cognitive training interventions have been shown to not only ameliorate subjective concerns but also improve objective cognitive function, such as memory and attention. It has also been associated with improved daily functioning and physical function.

The BrainHQ (Posit Science®) is an adaptive cognitive training program that addresses CRCI through scientifically validated exercises and an adaptive algorithm targeting memory, attention, and processing speed. The program's efficacy has been documented in diverse settings, including breast cancer survivors. Despite its use in other populations, cognitive training's potential in gynecologic oncology patients is unexplored.

This study will enroll patients with advanced gynecologic cancers who have completed adjuvant chemotherapy and are currently in surveillance with at least stable disease. Patients will be included if they screen positive for subjective report of cognitive impairment. This project will provide important, currently unknown information on the feasibility and acceptability of a cognitive training intervention in patients with advanced gynecologic cancers who report cognitive impairment following primary systemic therapy.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female; ≥18 years of age
  • Presents to clinic with a confirmed diagnosis of a gynecologic cancer (e.g., ovarian, endometrial, cervical, or vulvar cancer) who have completed adjuvant chemotherapy with at least stable disease at time of screening.
  • Screen positive for subjective cognitive impairment by answering affirmatively to at least one of three screener questions
  • Fluent in spoken and written English
  • Have access to the internet to complete assessments

Exclusion Criteria:

  • Patients who have not received chemotherapy
  • Patients with pre-existing neuropsychiatric disorders that would impact cognitive function, such as dementia, Alzheimer's disease, and schizophrenia.
  • Patients with non-gynecologic causes of incurable metastatic cancers.
  • Patients undergoing active interventions in other cognitive trials or patients currently using cognitive training programs such as Brain HQ, Luminosity, Elevate, Peak, Fit Brains, or CogniFit.
  • Patients with self-report of learning disability or an unwillingness to participate in technology-based cognitive training programs.
  • Pregnant women or prisoners
  • Patients with impaired-decision making capacity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GYNCOG Intervention
Participants in the GYNCOG arm will be asked to participate in a home-based cognitive training program utilizing BrainHQ on study-provided tablets.
Behavioral: GYNCOG

Participants in the GYNCOG arm will be asked to participate in a home-based cognitive training program utilizing BrainHQ. Participants will be instructed to use the Brain HQ app for approximately 2.5 hours per week. Patients will be provided with a calendar to help keep track of daily BrainHQ use, including the number of exercises completed and the amount of time spent on the app per day.

Patients will be asked to undergo the exercises that target the speed and accuracy of information processing. Examples of the exercises include:

Double Decision: This exercise tests your ability to quickly identify and choose between two options.

Eye for Detail: It challenges participants to spot small differences between two similar images.

Participants will be asked to train approximately 30 minutes per BrainHQ session, 5 times per week (i.e., 2.5 hours per week) for 10 weeks, for a total of approximately 25 hours.
No Intervention: Control Group
Patients in the Control Group arm will receive usual care with no cognitive intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment Compliance
Time Frame: 20 weeks
Assessment compliance will be defined as completing the cognitive assessments at baseline and at 10 weeks. The study will be considered feasible in terms of assessment compliance if at least 65% of all patients are compliant.
20 weeks
Adherence
Time Frame: 10 weeks
Adherence will be defined as completing ≥80% of intended BrainHQ exercises over 10 weeks. The intervention would be considered not feasible if ≤ 28/40 of patients are considered adherent.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 10 weeks
Acceptability will be measured at the end of the intervention period using the Acceptability of Intervention Measure, a validated 4-item measure of perceived intervention acceptability. Total score ranges from 4-20, with higher scores indicating greater acceptability.
10 weeks
Change in Patient Reported Cognitive Function
Time Frame: 20 weeks
Cognitive function will be measured via the Patient-Reported Outcomes Measurement Information System short-form on cognitive function. Each item on the measure is rated on a 5-point scale with a range in score from 6 to 30 with higher scores indicating greater cognitive impairment.
20 weeks
Change in Objective Cognitive Function
Time Frame: 20 weeks
Objective cognitive function will be measured via the Montreal Cognitive Assessment-Blind version 8. This is a modified version of the standard Montreal Cognitive Assessment, which is designed to be used in situations where visual components of cognitive testing are not feasible and useful for testing in remote settings. The MoCA is a widely used screening tool for detecting cognitive impairment, assessing domains like memory, attention, language, and executive function. Total score ranges from 0-22, with higher scores indicating greater cognitive function.
20 weeks
Change in Physical Function
Time Frame: 20 weeks
Physical function will be measured via the Patient-Reported Outcomes Measurement Information System short-form on physical function. Each item on the measure is rated on a 5-point scale with a range in score from 4 to 20 with lower scores indicating greater physical function.
20 weeks
Change in Fatigue
Time Frame: 20 weeks
Fatigue will be measured via the Patient-Reported Outcomes Measurement Information System short-form on fatigue. Each item on the measure is rated on a 5-point scale with a range in score from 4 to 20 with higher scores indicating greater fatigue.
20 weeks
Change in Illness Impact on Social Roles and Daily Tasks
Time Frame: 20 weeks
This will be measured via the Patient-Reported Outcomes Measurement Information System short-form on illness impact on social roles and daily tasks. Each item on the measure is rated on a 5-point scale with a range in score from 4 to 20 with higher scores indicating greater satisfaction in performing daily tasks.
20 weeks
Change in Sleep Disturbance
Time Frame: 20 weeks
Sleep disturbance will be measured via the Patient-Reported Outcomes Measurement Information System short-form on sleep disturbance. Each item on the measure is rated on a 5-point scale with a range in score from 4 to 20 with higher scores indicating greater sleep disturbance.
20 weeks
Change in Depression
Time Frame: 20 weeks
Depression will be measured via the Patient-Reported Outcomes Measurement Information System short-form on depression. Each item on the measure is rated on a 5-point scale with a range in score from 4 to 20 with higher scores indicating greater depression.
20 weeks
Change in Anxiety
Time Frame: 20 weeks
Anxiety will be measured via the Patient-Reported Outcomes Measurement Information System short-form on anxiety. Each item on the measure is rated on a 5-point scale with a range in score from 4 to 20 with higher scores indicating greater anxiety.
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Friends of Prentice

Investigators

  • Principal Investigator: Emma Barber, MD, MS, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2025

Primary Completion (Actual)

December 15, 2025

Study Completion (Actual)

March 20, 2026

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00222610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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