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Cognitive Remediation Therapy for Brain Tumor Patients: Improving Working Memory

Primary Purpose

Glioma, Brain Tumor, Primary

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CogMed®
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glioma focused on measuring High grade gliomas (WHO grade III or IV), Low grade gliomas (WHO Grade II)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University/Massey Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High grade gliomas(WHO grade III or IV; n=15)

Low grade gliomas(WHO grade II; n=15)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Treatment enrollment rates
Determine feasibility and acceptability of the CogMed training program by assessing treatment enrollment
Attrition rates
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
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
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
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
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).
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.
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).
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).

Secondary Outcome Measures

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).
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).

Full Information

First Posted
October 11, 2017
Last Updated
October 16, 2020
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT03323450
Brief Title
Cognitive Remediation Therapy for Brain Tumor Patients: Improving Working Memory
Official Title
Cognitive Remediation Therapy for Brain Tumor Patients: Improving Working Memory
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Brain Tumor, Primary
Keywords
High grade gliomas (WHO grade III or IV), Low grade gliomas (WHO Grade II)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High grade gliomas(WHO grade III or IV; n=15)
Arm Type
Experimental
Arm Description
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.
Arm Title
Low grade gliomas(WHO grade II; n=15)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CogMed®
Intervention Description
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
Primary Outcome Measure Information:
Title
Treatment enrollment rates
Description
Determine feasibility and acceptability of the CogMed training program by assessing treatment enrollment
Time Frame
6 months
Title
Attrition rates
Description
Determine feasibility and acceptability of the CogMed training program by assessing attrition rates.
Time Frame
6 months
Title
Change in scores on Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) over time
Description
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).
Time Frame
Baseline to 6 months
Title
Change in scores on Conners' Continuous Performance Test - Third Edition (CPT-3) over time
Description
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).
Time Frame
Baseline to 6 months
Title
Change in scores on Delis-Kaplan Executive Function System (D-KEFS) over time
Description
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).
Time Frame
Baseline to 6 months
Title
Change in scores on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS-Update A, B, C, or D) over time
Description
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).
Time Frame
Baseline to 6 months
Title
Scores on Test of Premorbid Functioning (TOPF) at baseline
Description
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.
Time Frame
Baseline
Title
Change in scores on Trial Making Test (TMT) over time
Description
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).
Time Frame
Baseline to 6 months
Title
Change in scores on Wechsler Memory Scale - Fourth Edition (WMS-IV) over time
Description
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).
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Change in scores on Beck Anxiety Inventory (BAI) over time
Description
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).
Time Frame
Baseline to 6 months
Title
Change in scores on Beck Depression Inventory-II (BDI-II) over time
Description
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).
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashlee Loughan, PhD
Organizational Affiliation
Massey Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34491526
Citation
Braun SE, Aslanzadeh FJ, Lanoye A, Fountain-Zaragoza S, Malkin MG, Loughan AR. Working memory training for adult glioma patients: a proof-of-concept study. J Neurooncol. 2021 Oct;155(1):25-34. doi: 10.1007/s11060-021-03839-y. Epub 2021 Sep 7.
Results Reference
derived

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Cognitive Remediation Therapy for Brain Tumor Patients: Improving Working Memory

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