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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Cognitive Assessment | Other | 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.
There is no follow-up care as part of this research study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lakshmi Nayak, MD | Contact | 617-632-2166 | Lakshmi_Nayak@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lakshmi Nayak, MD | Dana-Farber Cancer Institute | Principal Investigator |
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The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011788 | Quality of Life |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
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|
| Traditional Neuropsychological Testing | Behavioral | 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 Questionnaires | Other | Participants will complete the Functional Assessment of Cancer Therapy - Brain (FACT-br) and Hospital Anxiety and Depression Scale (HADS) at baseline and follow-up timepoints. |
|
| Brain MRI (Standard of Care) | Other | Brain MRI data will be collected as part of routine clinical care to assess tumor response, stability, or progression, and correlated with cognitive test results. |
|
| Baseline, 6 and 12 month follow ups |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D004778 |
| Environment and Public Health |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |