Neurocognitive Assessment CNSL and LGG

N/ANot Yet RecruitingNCT07710131

Dana-Farber Cancer Institute36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

PCNSL Brain Tumor Cognitive Dysfunction IDH Mutation Low-grade Glioma

Interventions

Digital Cognitive Assessment (TestMyBrain and Mobile Toolbox)BEHAVIORAL

Participants will complete a battery of digital cognitive tests using the TestMyBrain and Mobile Toolbox platforms, assessing attention, processing speed, executive function, and memory. Assessments will be conducted in clinic and at home at multiple timepoints.

Traditional Neuropsychological TestingBEHAVIORAL

Participants will complete standard paper-and-pencil neuropsychological tests, including WAIS-IV Digit Span, Brief Test of Attention, Symbol Digits Modalities Test, Trail Making Test Parts A and B, Stroop, and Hopkins Verbal Learning Test-Revised.

Quality of Life and Mood QuestionnairesOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Evaluating the Construct Validity of Digital Cognitive Tests

To evaluate the construct validity of digital cognitive tests by comparing domain-specific composite scores derived from traditional neuropsychological and digital cognitive measures of attention, processing speed, executive functioning, and memory. Baseline traditional and digital cognitive data will be collected from PCNSL patients (before chemotherapy) and LGG patients (post-resection). Traditional tests include WAIS-IV Digit Span, Brief Test of Attention, Symbol Digit Modalities Test, Trail Making Test A/B, Stroop, and HVLT-R. Digital platforms include TestMyBrain (Digit Span, Digit Symbol Matching, Trails A/B, Reaction Time, Verbal Paired Associates) and Mobile Toolbox (Arrow Matching, Sequences, Number-Symbol Match, Shape-Color Sorting, and Associative Memory). Moderate to strong correlations between traditional and digital composite domain-specific composite scores will be interpreted as having evidence of convergent validity.

Time frame: Baseline assessment only, conducted at study enrollment for each participant.

Evaluating the Discriminant Validity of Digital Cognitive Tests with Emotional Wellbeing Measures

To evaluate the discriminant validity of the digital cognitive tests in both cohorts ( PCNSL and LGG) by examining correlations between digital global composite indices of TestMyBrain and Mobile Toolbox tests with the emotional wellbeing subscale of the FACT-BR and the Hospital Anxiety and Depression scale. For low-grade glioma (LGG) patients, assessments will be conducted at baseline; for primary central nervous system lymphoma (PCNSL) patients, assessments will be conducted at baseline. Small magnitude correlations are expected to provide evidence of discriminant validity.

Time frame: Baseline

Assessing Test-Retest Reliability of the Digital Cognitive Tests Across Repeated Administrations and Different Environments.

Test-retest reliability of the TestMyBrain and Mobile Toolbox cognitive tests will be evaluated in both cohorts (PCNSL and LGG) by examining correlations between baseline test scores of both groups and scores obtained at the 6-month and 12-month follow-up assessments. The baseline evaluation and 12-month evaluations will be completed in the clinic/hospital setting, and the 6-month follow-up digital cognitive tests will be completed at home. Correlations between baseline and 6-month scores will be used to evaluate the reliability of the digital cognitive measures across clinic-to-home testing environments. Correlations between baseline and 12-month scores will be used to evaluate the reliability of the digital cognitive measures across repeated assessments conducted in the same clinic/hospital environment.

Central Contacts

Lakshmi Nayak, MD

CONTACT

617-632-2166 Lakshmi_Nayak@dfci.harvard.edu

Data from ClinicalTrials.gov

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