Neurocognitive Assessment CNSL and LGG

Dana-Farber Cancer Institute

Status: Begins enrollment in 1 month

Conditions: Low-grade Glioma; IDH Mutation; PCNSL; Brain Tumor; Cognitive Dysfunction

Treatments: Behavioral: Digital Cognitive Assessment (TestMyBrain and Mobile Toolbox); Other: Quality of Life and Mood Questionnaires; Other: Brain MRI (Standard of Care); Behavioral: Traditional Neuropsychological Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT07710131

25-759

Details and patient eligibility

About

This study is to determine whether self-administered digital cognitive tests can serve as accurate and reliable alternatives to established neuropsychological tests for evaluating cognitive functioning in participants with primary central nervous system lymphoma and low-grade gliomas.

Full description

This is a prospective, longitudinal, pilot study evaluating the validity and reliability of select digital cognitive tests compared to traditional neuropsychological measures in participants with newly diagnosed primary central nervous system lymphoma (PCNSL) and IDH-mutant low-grade gliomas (LGG).

Participants will complete both traditional paper-and-pencil neuropsychological tests and digital cognitive assessments at baseline, 6 months, and at post-treatment or 12-month follow-up, depending on diagnosis. Quality of life and mood will be assessed using the FACT-br and HADS questionnaires and Brain MRI (Magnetic Resonance Imaging). The study will evaluate validity, as well as test-retest reliability of digital cognitive tests, and explore associations between cognitive performance and neuroimaging outcomes.

It is expected about 36 people will participate in this research study within 12 months.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histopathologically confirmed newly diagnosed primary CNS diffuse large B-cell lymphoma (DLBCL) OR
• Histopathologically confirmed IDH-M low grade glioma diagnosis in the past 12 months who have not started tumor directed therapy (if applicable).
• Age ≥ 18 years.
• Ability to consent to study.

Exclusion criteria

• Patients who have severe visual impairment that cannot be corrected with glasses to read regular sized print.
• Patients who have known psychiatric or substance abuse disorders that would interfere with their cooperation in completing the requirements of the study.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Digital Cognitive Assessment

Other group

Description:

Participants with newly diagnosed PCNSL or IDH-mutant LGG will undergo both traditional neuropsychological testing and digital cognitive assessments (TestMyBrain and Mobile Toolbox) at specified timepoints (baseline, 6 months, post-treatment or 12-14 months). Quality of life and mood questionnaires will also be administered. Brain MRI data will be collected as part of standard care. Participants will be sent a link to complete the digital cognitive tests at home. Questionnaires will also be sent via email to complete. Data will be collected from brain MRIs obtained as part of standard of care/routine surveillance. * Screening visit * Baseline visit (2- months) * Follow-Up visit (3-month) * End of Treatment 2 months after completing treatment (PCNSL only) * Final Assessment 12-14 months after baseline (LGG only). * Brain MRI (standard of care) based on participant permission There is no follow-up care as part of this research study.

Treatment:

Behavioral: Traditional Neuropsychological Testing

Other: Brain MRI (Standard of Care)

Other: Quality of Life and Mood Questionnaires

Behavioral: Digital Cognitive Assessment (TestMyBrain and Mobile Toolbox)