Cognitive Remediation Therapy for Brain Tumor Patients: Improving Working Memory
- Conditions
- GliomaBrain Tumor, Primary
- Interventions
- Behavioral: CogMed®
- Registration Number
- NCT03323450
- Lead Sponsor
- Virginia Commonwealth University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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)
- If they are not patients of Massey Cancer Center or do not meet the inclusion criteria listed above
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low grade gliomas(WHO grade II; n=15) CogMed® The two groups will follow identical study timelines. Participants will receive a 1 hour training session on CogMed® (PI or trained graduate student). Participants will complete 5 weeks of CogMed® training within their own home. It consists of 25 training sessions. Each session lasts 30-45 minutes.The study team will check in with participants once a week via phone or email. Brief neuropsychological evaluations will be conducted at 4 time points. Each assessment will take approximately 30-60 minutes. Each participant will receive a $25 gift card to the VCU medical center gift shop at two time points. High grade gliomas(WHO grade III or IV; n=15) CogMed® The two groups will follow identical study timelines. Participants will receive a 1 hour training session on CogMed® (PI or trained graduate student). Participants will complete 5 weeks of CogMed® training within their own home. It consists of 25 training sessions. Each session lasts 30-45 minutes.The study team will check in with participants once a week via phone or email. Brief neuropsychological evaluations will be conducted at 4 time points. Each assessment will take approximately 30-60 minutes. Each participant will receive a $25 gift card to the VCU medical center gift shop at two time points.
- Primary Outcome Measures
Name Time Method 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 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).
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 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).
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 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 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).
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).
- Secondary Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
Virginia Commonwealth University/Massey Cancer Center
🇺🇸Richmond, Virginia, United States