Brain Tumor, Primary, Glioma
Conditions
Keywords
High grade gliomas (WHO grade III or IV), Low grade gliomas (WHO Grade II)
Brief summary
To investigate a computer-based Cognitive Remediation Therapy (CRT) for brain tumor patients at the Massey Cancer Center on measures of cognitive functioning (e.g., working memory, attention, processing speed, language, visuospatial functioning, immediate and delayed memory, or executive functioning) over time.
Detailed description
Participants will be recruited by their neuropsychologist in the VCU Massey Cancer Center following standard neuropsychological evaluation (their neuro-oncologist may refer them to this study). If meeting inclusion criteria (described in later sections on participants), participants will be recruited and enrolled in the study. Two groups will be formed: High grade gliomas (WHO grade III or IV; n=15) and Low grade gliomas (WHO grade II; n=15). Participants will be followed over 11 months. The two groups will follow identical study timelines.
Interventions
BEHAVIORALCogMed®
It consists of 25 training sessions which can all be completed online and at home. Each session lasts 30-45 minutes. They must have a computer at home compatible with the CogMed® program. Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care): 1. Baseline before the participant is introduced to the CogMed® training program 2. Within 2 weeks of completion of the CogMed® program 3. At 3 months of completion of the CogMed® program to establish maintenance of gains 4. At 6 months of completion of the CogMed® program to establish longer-term maintenance of gains
Sponsors
Virginia Commonwealth University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed primary brain tumor diagnosis via MRI and their neuro-oncologist * A minimum of 2 months post-surgical resection or biopsy(if applicable) * and/or a minimum 1 month post radiation treatment (if applicable) * Karnofsky performance status more than 60 * Estimated intelligence at least 80 (standard score) * Demonstrated attention difficulties (T-score of at least 65 on attention questionnaire or 1 or more standard deviations below mean on direct attention measures) * No history of cognitive disorder * No history of mood disorder * Predicted life expectancy of at least 12 months * Computer capability at home or provided a departmental iPad Mini to borrow for study purposes * Primarily English speaking * Aged 18+ (for which there is available age-adjusted neuropsychological testing standardization / normative data)
Exclusion criteria
* If they are not patients of Massey Cancer Center or do not meet the inclusion criteria listed above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in scores on Wechsler Memory Scale - Fourth Edition (WMS-IV) over time | Baseline to 6 months | Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Wechsler Memory Scale - Fourth Edition (WMS-IV). |
| Scores on Test of Premorbid Functioning (TOPF) at baseline | Baseline | Brief neuropsychological evaluations will be conducted at baseline before the participant is introduced to the CogMed® training program. During this time point, the scores are measured and compared on Test of Premorbid Functioning (TOPF) with other psychological measures. |
| Change in scores on Trial Making Test (TMT) over time | Baseline to 6 months | Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Trial Making Test (TMT). |
| Treatment enrollment rates | 6 months | Determine feasibility and acceptability of the CogMed training program by assessing treatment enrollment |
| Attrition rates | 6 months | Determine feasibility and acceptability of the CogMed training program by assessing attrition rates. |
| Change in scores on Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) over time | Baseline to 6 months | Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Behavior Rating Inventory of Executive Function-Adult (BRIEF-A). |
| Change in scores on Conners' Continuous Performance Test - Third Edition (CPT-3) over time | Baseline to 6 months | Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Conners' Continuous Performance Test - Third Edition (CPT-3). |
| Change in scores on Delis-Kaplan Executive Function System (D-KEFS) over time | Baseline to 6 months | Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Delis-Kaplan Executive Function System (D-KEFS). |
| Change in scores on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS-Update A, B, C, or D) over time | Baseline to 6 months | Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS-Update A, B, C, or D). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in scores on Beck Depression Inventory-II (BDI-II) over time | Baseline to 6 months | Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Beck Depression Inventory-II (BDI-II). |
| Change in scores on Beck Anxiety Inventory (BAI) over time | Baseline to 6 months | Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care). Baseline before the participant is introduced to the CogMed® training program, within 2 weeks of completion of the CogMed® program, at 3 months of completion of the CogMed® program to establish maintenance of gains, and at 6 months of completion of the CogMed® program to establish longer-term maintenance of gains. During these time points, the scores are measured on Beck Anxiety Inventory (BAI). |
Countries
United States
Outcome results
None listed