GYNecologic Cancer-Related COGnitive Impairment
- Conditions
- Ovarian CancerEndometrial CancerCervical CancersVulvar CancersUterine CancerCervix CancerOvary Cancer
- Registration Number
- NCT06662435
- Lead Sponsor
- Northwestern University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Assessment Compliance 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.
Adherence 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.
- Secondary Outcome Measures
Name Time Method Acceptability 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.
Change in Patient Reported Cognitive Function 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.
Change in Objective Cognitive Function 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.
Change in Physical Function 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.
Change in Fatigue 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.
Change in Illness Impact on Social Roles and Daily Tasks 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.
Change in Sleep Disturbance 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.
Change in Depression 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.
Change in Anxiety 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.
Trial Locations
- Locations (1)
Northwestern University
🇺🇸Chicago, Illinois, United States