GYNecologic Cancer-Related COGnitive Impairment

NCT ID: NCT06662435

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-07
• Study Completion Date: 2028-12-31

Brief Summary

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.

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.

Conditions

Ovarian Cancer; Endometrial Cancer; Cervical Cancers; Vulvar Cancers; Uterine Cancer; Cervix Cancer; Ovary Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

GYNCOG

Intervention Type: BEHAVIORAL

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.

Control Group

Patients in the Control Group arm will receive usual care with no cognitive intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Friends of Prentice

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Emma Barber

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emma Barber, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anne Grace, PhD

Role: CONTACT

anne@northwestern.edu

312-503-4165

Isabelle Kildee

Role: CONTACT

isabelle.kildee@northwestern.edu

312-472-5726

Facility Contacts

Anne Grace, PhD

Role: primary

anne@northwestern.edu

312-503-4165

Other Identifiers

STU00222610

Identifier Type: -

Identifier Source: org_study_id