Cognitive Remediation Therapy for Brain Tumor Patients: Improving Working Memory
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in scores on Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) over time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •If they are not patients of Massey Cancer Center or do not meet the inclusion criteria listed above
结局指标
主要结局
Change in scores on Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) over time
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 6 months
Determine feasibility and acceptability of the CogMed training program by assessing treatment enrollment
Attrition rates
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Change in scores on Beck Depression Inventory-II (BDI-II) over time(Baseline to 6 months)
- Change in scores on Beck Anxiety Inventory (BAI) over time(Baseline to 6 months)