Cognitive Remediation Therapy for Brain Tumor Patients: Improving Working Memory

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.

Study Overview

• Status: Completed
• Conditions: Glioma; Brain Tumor, Primary
• Intervention / Treatment: Behavioral: CogMed®

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University/Massey Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High grade gliomas(WHO grade III or IV; n=15); 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.	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
Experimental: Low grade gliomas(WHO grade II; n=15); 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment enrollment rates	Determine feasibility and acceptability of the CogMed training program by assessing treatment enrollment	6 months
Attrition rates	Determine feasibility and acceptability of the CogMed training program by assessing attrition rates.	6 months
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Ashlee Loughan, PhD, Massey Cancer Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: High grade gliomas (WHO grade III or IV); Low grade gliomas (WHO Grade II)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Glioma; Brain Neoplasms
• Other Study ID Numbers: MCC-17-13581

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No