NCT06662435

GYNecologic Cancer-Related COGnitive Impairment

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-07
• Primary completion: 2025-12-15
• Completion: 2026-03-20
• First posted: 2024-10-29
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States