Ovarian CancerGYNCOGNCT06662435
GYNecologic Cancer-Related COGnitive Impairment
A study testing GYNCOG in people with Ovarian Cancer and Endometrial Cancer, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer, Cervical Cancers
- What is being tested?
- GYNCOG
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2025to 20 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot and Mixed-Methods Study of GYNecologic Cancer-Related COGnitive Impairment
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.
Read the 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
- Being tested
- GYNCOG
- Keywords
- cognitive impairment, gynecologic cancer, cancer related cognitive impairment
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Uterine Neoplasms, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GYNCOGBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: GYNCOG |
| Control Group | No intervention | Patients in the Control Group arm will receive usual care with no cognitive intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 weeks
Secondary outcomes (9)
Acceptability
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.
Measured: 10 weeks
Change in Patient Reported Cognitive Function
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.
Measured: 20 weeks
Change in Objective Cognitive Function
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.
Measured: 20 weeks
Change in Physical Function
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.
Measured: 20 weeks
Change in Fatigue
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.
Measured: 20 weeks
Change in Illness Impact on Social Roles and Daily Tasks
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.
Measured: 20 weeks
Change in Sleep Disturbance
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.
Measured: 20 weeks
Change in Depression
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.
Measured: 20 weeks
Change in Anxiety
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.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start7 Feb 2025
- Primary completion15 Dec 2025
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Friends of Prentice
- Responsible party
- Principal investigator, Emma Barber, Northwestern University
- Investigators
- Emma Barber, MD, MS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662435
- Sponsor's protocol ID
- STU00222610
- Acronym
- GYNCOG
- Status last verified
- Mar 2026
- First submitted
- 25 Oct 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang CC, Kildee I, Reasner E, Bednorski I, Ma YA, Duggan B, Silberman J, Grace A, Kocherginsky M, Barber EL. Feasibility, adherence, and patient experiences in a pilot randomized trial of home-based cognitive training intervention for gynecologic cancer-related cognitive impairment. Gynecol Oncol. 2026 Aug 7;212:64-71. doi: 10.1016/j.ygyno.2026.08.001. Online ahead of print.
PubMed 42567117
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot and Mixed-Methods Study of GYNecologic Cancer-Related COGnitive Impairment
- ClinicalTrials.gov ID
- NCT06662435
- Acronym / sponsor ID
- GYNCOG / STU00222610
- Conditions
- Ovarian Cancer, Endometrial Cancer, Cervical Cancers, Vulvar Cancers, Uterine Cancer, Cervix Cancer
- Keywords
- cognitive impairment, gynecologic cancer, cancer related cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Friends of Prentice
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GYNCOG Intervention | Experimental | Behavioral: GYNCOGParticipants in the GYNCOG arm will be asked to participate in a home-based cognitive training program utilizing BrainHQ on study-provided tablets. |
| Control Group | No intervention | –Patients in the Control Group arm will receive usual care with no cognitive intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GYNCOGParticipants 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. | Behavioural | GYNCOG Intervention |
Primary outcome
Assessment Compliance
Time frame: 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
Time frame: 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.
9 secondary outcomes
Acceptability
Time frame: 10 weeks
Change in Patient Reported Cognitive Function
Time frame: 20 weeks
Change in Objective Cognitive Function
Time frame: 20 weeks
Change in Physical Function
Time frame: 20 weeks
Change in Fatigue
Time frame: 20 weeks
Change in Illness Impact on Social Roles and Daily Tasks
Time frame: 20 weeks
Change in Sleep Disturbance
Time frame: 20 weeks
Change in Depression
Time frame: 20 weeks
Change in Anxiety
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Derived from this study: PubMed 42567117Wang CC, Kildee I, Reasner E, Bednorski I, Ma YA, Duggan B, Silberman J, Grace A, Kocherginsky M, Barber EL. Feasibility, adherence, and patient experiences in a pilot randomized trial of home-based cognitive training intervention for gynecologic cancer-related cognitive impairment. Gynecol Oncol. 2026 Aug 7;212:64-71. doi: 10.1016/j.ygyno.2026.08.001. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Barber, MD, MS principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GYNCOG in people with Ovarian Cancer and Endometrial Cancer, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment Compliance (time frame: 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06662435, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.