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

Trial Summary

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 data supports the effectiveness of the treatment GYNCOG for cognitive training in gynecologic cancers?

The pilot study on a psychoeducational intervention for cancer-related cognitive impairment in gynecologic cancer survivors suggests that such interventions can be feasible and applicable, indicating potential benefits for cognitive training like GYNCOG. ^{1 2 3 4 5}

How is the treatment GYNCOG different from other treatments for gynecologic cancers?

GYNCOG is unique because it focuses on cognitive training to address cancer-related cognitive impairment (CRCI) in gynecologic cancer survivors, which is not typically targeted by standard cancer treatments that focus on the physical aspects of the disease. ^{1 3 4 6 7}

What is the purpose of this trial?

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.

Research Team

Emma Barber

Principal Investigator

Northwestern University

Eligibility Criteria

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.

I am a woman aged 18 or older.

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

Exclusion Criteria

I have not undergone chemotherapy.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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-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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Variations in gynecologic oncology training in low (LIC) and middle income (MIC) countries (LMICs): Common efforts and challenges. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Long-term trajectories of psychological adaptation among women diagnosed with gynecological cancers. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Prevalence and factors associated with cognitive deficit in women with gynecologic malignancies. [2022]

4. United States 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Psychosocial rehabilitation of gynecologic oncology patients. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

Surgical education and training program development for gynecologic oncology: American perspective. [2009]

7. Germany pubmed.ncbi.nlm.nih.gov

Cancer-related cognitive impairment (CRCI), depression and quality of life in gynecological cancer patients: a prospective study. [2021]