GYNecologic Cancer-Related COGnitive Impairment

NCT06662435 | Completed

• 1 other identifier: STU00222610
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cognitive impairment; gynecologic cancer; cancer related cognitive impairment

Outcome Measures

Primary Outcomes (2)

• Assessment Compliance

  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

  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 Outcomes (9)

• Acceptability

  10 weeks

• Change in Patient Reported Cognitive Function

  20 weeks

• Change in Objective Cognitive Function

  20 weeks

• Change in Physical Function

  20 weeks

• Change in Fatigue

  20 weeks

Study Arms (2)

GYNCOG Intervention

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

GYNCOG 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.

GYNCOG Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Friends of Prentice: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms; Vulvar Neoplasms; Uterine Neoplasms; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Diseases; Uterine Cervical Diseases; Vulvar Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Emma Barber, MD, MS

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: February 7, 2025
• Primary Completion: December 15, 2025
• Study Completion: March 20, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)