Clinical trial NCT06662435: GYNecologic Cancer-Related COGnitive Impairment
Official title: A Pilot and Mixed-Methods Study of GYNecologic Cancer-Related COGnitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Endometrial Cancer
Cervical Cancers
Vulvar Cancers
Uterine Cancer
Cervix Cancer
Ovary Cancer
Keywords: cognitive impairment
gynecologic cancer
cancer related cognitive impairment
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Friends of Prentice
First posted: 2024-10-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Assessment Compliance
timeFrame: 20 weeks
measure: Adherence
timeFrame: 10 weeks
Secondary outcomes:
measure: Acceptability
timeFrame: 10 weeks
measure: Change in Patient Reported Cognitive Function
timeFrame: 20 weeks
measure: Change in Objective Cognitive Function
timeFrame: 20 weeks
measure: Change in Physical Function
timeFrame: 20 weeks
measure: Change in Fatigue
timeFrame: 20 weeks
measure: Change in Illness Impact on Social Roles and Daily Tasks
timeFrame: 20 weeks
measure: Change in Sleep Disturbance
timeFrame: 20 weeks
measure: Change in Depression
timeFrame: 20 weeks
measure: Change in Anxiety
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Emma Barber, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: