Cognitive Training for Gynecologic Cancers

(GYNCOG Trial)

Overseen By Anne Grace, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Dementia, Alzheimer's, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home-based cognitive training program called GYNCOG for women who have had gynecologic cancer, such as ovarian or cervical cancer, and have completed chemotherapy. The program aims to assist those who feel their thinking or memory has been affected by cancer treatment. Participants will use a tablet program to perform brain exercises at home. Women who have completed chemotherapy and feel their cognitive abilities have been impaired may be suitable candidates.

As an unphased trial, this study offers a unique opportunity to potentially improve cognitive function from the comfort of home.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this cognitive training intervention is safe for gynecologic cancer patients?

Research has shown that cognitive training programs, like the GYNCOG intervention, are generally safe for cancer survivors. Studies have found that similar digital training programs, such as BrainHQ, have been used by breast and cervical cancer survivors without serious side effects. Designed for home use, these programs aim to improve memory and thinking skills.

Although this specific study is new, the safe use of similar programs in other cancer groups is encouraging. Reports have not indicated major negative effects from these types of cognitive training. This suggests that the GYNCOG intervention is likely well-tolerated by patients. Prospective participants can find reassurance in this previous evidence regarding its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GYNCOG cognitive training program because it offers a novel approach to supporting women with gynecologic cancers. Unlike standard treatments that primarily focus on the physical aspects of cancer, GYNCOG targets cognitive function, which can be affected by both the disease and its treatment. This program uses BrainHQ, a scientifically designed cognitive training tool, delivered via tablets, allowing participants to engage in training conveniently from home. By potentially improving memory, attention, and processing speed, GYNCOG could enhance quality of life in ways traditional cancer treatments don't address.

What evidence suggests that the GYNCOG intervention is effective for cancer-related cognitive impairment?

This trial will compare the GYNCOG intervention with a control group receiving usual care. Research has shown that cognitive training can help with thinking and memory problems experienced after cancer treatment. Although specific information about the GYNCOG program is limited, similar programs like BrainHQ have shown promise in other studies. These programs have improved thinking speed and memory in various groups. By engaging in these exercises, patients may enhance brain function, potentially reducing cognitive issues related to gynecologic cancer treatments. ^{3 4 6 7 8}

Who Is on the Research Team?

Emma Barber

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for women over 18 with gynecologic cancers like ovarian, endometrial, cervical, or vulvar cancer who've finished chemotherapy and feel they have cognitive issues. They must speak English and have internet access to do assessments but can't join if they're pregnant, imprisoned, using other cognitive programs, or have conditions like dementia affecting their cognition.

Inclusion Criteria

I have a gynecologic cancer and finished chemotherapy with no worsening of my condition.

Screen positive for subjective cognitive impairment by answering affirmatively to at least one of three screener questions

I am a woman aged 18 or older.

Exclusion Criteria

Patients with pre-existing neuropsychiatric disorders that would impact cognitive function, such as dementia, Alzheimer's disease, and schizophrenia

I have not undergone chemotherapy.

My cancer is incurable, has spread, and is not related to gynecologic origins.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a home-based cognitive training program using BrainHQ for 10 weeks

10 weeks

Home-based, self-administered

Follow-up

Participants are monitored for changes in cognitive function, depression, anxiety, and other outcomes

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GYNCOG

Trial Overview The study tests a home-based cognitive training program tailored for patients with gynecologic cancer who've completed chemotherapy and report thinking problems. It aims to see how well the intervention works in improving cognitive function post-treatment.

How Is the Trial Designed?

Group I: GYNCOG Intervention Experimental Treatment 1 Intervention

Participants in the GYNCOG arm will be asked to participate in a home-based cognitive training program utilizing BrainHQ on study-provided tablets.

Group II: Control Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Friends of Prentice

Collaborator

Trials

6

Recruited

880+

Published Research Related to This Trial

In a study of 165 women with gynecologic cancers, 24% exhibited cognitive impairment, as indicated by low scores on the Montreal Cognitive Assessment (MoCA), with mean scores suggesting a significant prevalence of cognitive deficits.

Factors such as older age, non-white race/ethnicity, lower education levels, and higher pain levels were associated with lower cognitive scores, highlighting the need for further research on how these cognitive deficits may affect treatment adherence and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and factors associated with cognitive deficit in women with gynecologic malignancies. Van Arsdale, A., Rosenbaum, D., Kaur, G., et al.[2022]

Successful gynecologic oncologists require a combination of extensive knowledge, strong interpersonal skills, surgical expertise, and the ability to provide comprehensive care, which can be developed through a well-structured fellowship program.

Gynecologic oncology fellowship programs must select highly qualified fellows, have dedicated faculty, and provide a supportive environment with adequate clinical material, while also emphasizing education through formal training and hands-on experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical education and training program development for gynecologic oncology: American perspective. Hoffman, MS., Bodurka, DC.[2009]

The study identified key risk factors for poor psychological adaptation in 113 women undergoing treatment for gynecological cancer, including lower physician-rated performance status, self-reported functional impairment, and lack of supportive social networks.

Women who had previously received psychological treatment, were less expressive of positive emotions, and struggled to find positives in their cancer experience were more likely to experience long-term psychological distress, highlighting the need for targeted psychological support in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term trajectories of psychological adaptation among women diagnosed with gynecological cancers. Manne, S., Rini, C., Rubin, S., et al.[2021]

In-hospital individual counseling for patients with newly diagnosed gynecologic cancers significantly reduced confusion and negative self-perception at 3 months compared to those who did not receive counseling.

Counseling positively influenced the return to normal vocational and sexual functions within the first year after treatment, despite the overall adverse effects of cancer diagnosis and treatment on these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial rehabilitation of gynecologic oncology patients. Capone, MA., Good, RS., Westie, KS., et al.[2006]

Cervical cancer is a significant health issue in developing countries, where mortality rates are high, highlighting the urgent need for improved treatment and training for healthcare providers.

The paper discusses the inconsistencies in gynecologic oncology training in low- and middle-income countries (LMICs) and the challenges faced, aiming to inform future strategies for enhancing cancer care in these regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variations in gynecologic oncology training in low (LIC) and middle income (MIC) countries (LMICs): Common efforts and challenges. Johnston, C., Ng, JS., Manchanda, R., et al.[2022]

A 15-hour psychoeducational intervention for patients with gynecologic cancer showed significant improvements in perceived cognitive impairment and quality of life, indicating its effectiveness in managing cancer-related cognitive issues.

While a trainee-taught version of the intervention did not show significant changes in perceived cognitive impairment, it did lead to notable improvements in applied cognition abilities, suggesting potential for further development and training in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging From the Haze: A Pilot Study Evaluating Feasibility of a Psychoeducational Intervention to Improve Cancer-Related Cognitive Impairment in Gynecologic Cancer Survivors. Liang, MI., Erich, B., Bailey, C., et al.[2019]

In a study of 73 women undergoing treatment for gynecological cancers, there was a significant reduction in perceived cognitive impairments six months after treatment, indicating that cognitive function may improve post-therapy.

The study also found a notable improvement in depression levels among participants, suggesting that while cognitive impairment is a concern for cancer survivors, it may not be directly linked to their depression or menopausal status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer-related cognitive impairment (CRCI), depression and quality of life in gynecological cancer patients: a prospective study. De Rosa, N., Della Corte, L., Giannattasio, A., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11413694/

The effectiveness of cognitive behavioral therapy in women ... The findings showed that gynecological cancer patients with CBT had improvements in depression and anxiety. Cancer patients were given various ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2347562524001847

The effectiveness of cognitive behavioral therapy in women ... The results of this study demonstrated that CBT improved the distress levels of gynecological cancer patients. The CBT helped reduce distress in cancer patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10191940/

Efficacy of exercise interventions for women during and after ... Preliminary research into the role of exercise post-gynaecological cancer suggests an improvement in exercise capacity, muscular strength, and agility.

4. ctv.veeva.com ctv.veeva.com/study/a-pilot-and-mixed-methods-study-of-gynecologic-cancer-related-cognitive-impairment

GYNecologic Cancer-Related COGnitive Impairment (GYNCOG) The goal of this study is to test a home-based and patient-tailored cognitive training intervention among gynecologic cancer patients who ...

5. read.houstonmethodist.org read.houstonmethodist.org/trailblazing-new-perspectives

Trailblazing New Perspectives Published in JAMA Network Open, Ramirez explained what the feasibility study results mean for future evaluations of gynecological cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6377208/

Chemotherapy-related cognitive dysfunction and effects on ... Chemotherapy-related cognitive dysfunction and effects on quality of life in gynecologic cancer patients.

7. brainhq.com brainhq.com/world-class-science/information-researchers/cancer-related-cognitive-impairment/

Cancer-Related Cognitive Impairment “Digital Goal Management Training for Cognitive Impairment in Cervical Cancer Survivors—a Randomized Comparison Study.” Journal of Cancer Survivorship.

8. centerwatch.com centerwatch.com/clinical-trials/listings/condition/30/cervical-cancer?activelyRecruiting=false&page=50

Cervical Cancer Clinical Research Trials The program's efficacy has been documented in diverse settings, including breast cancer survivors. Despite its use in other populations, cognitive training's ...