Cognitive Remediation Therapy for Brain Tumor Patients: Improving Working Memory

Glioma Clinical Trial

Official title:

Cognitive Remediation Therapy for Brain Tumor Patients: Improving Working Memory

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03323450
• Other study ID #: MCC-17-13581
• Status: Completed
• Phase: N/A
• Start date: October 20, 2017
• Est. completion date: June 1, 2020

Study information

• Verified date: October 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor, Primary
• Glioma

Intervention

Behavioral:
• CogMed®
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): 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 At 6 months of completion of the CogMed® program to establish longer-term maintenance of gains

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment enrollment rates	Determine feasibility and acceptability of the CogMed training program by assessing treatment enrollment	6 months
Primary	Attrition rates	Determine feasibility and acceptability of the CogMed training program by assessing attrition rates.	6 months
Primary	Change in scores on Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) over time	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).	Baseline to 6 months
Primary	Change in scores on Conners' Continuous Performance Test - Third Edition (CPT-3) over time	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).	Baseline to 6 months
Primary	Change in scores on Delis-Kaplan Executive Function System (D-KEFS) over time	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).	Baseline to 6 months
Primary	Change in scores on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS-Update A, B, C, or D) over time	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).	Baseline to 6 months
Primary	Scores on Test of Premorbid Functioning (TOPF) at 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.	Baseline
Primary	Change in scores on Trial Making Test (TMT) over time	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).	Baseline to 6 months
Primary	Change in scores on Wechsler Memory Scale - Fourth Edition (WMS-IV) over time	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).	Baseline to 6 months
Secondary	Change in scores on Beck Anxiety Inventory (BAI) over time	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).	Baseline to 6 months
Secondary	Change in scores on Beck Depression Inventory-II (BDI-II) over time	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).	Baseline to 6 months