Cognitive Remediation Therapy for Brain Tumor Patients: Improving Working Memory

NCT03323450 | Completed

• 1 other identifier: MCC-17-13581
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma; Brain Tumor, Primary

Keywords

High grade gliomas (WHO grade III or IV); Low grade gliomas (WHO Grade II)

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• Change in scores on Beck Anxiety Inventory (BAI) over time

  Baseline to 6 months

• Change in scores on Beck Depression Inventory-II (BDI-II) over time

  Baseline to 6 months

Study Arms (2)

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

EXPERIMENTAL

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®

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

EXPERIMENTAL

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®

Interventions

CogMed® BEHAVIORAL

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): 1. Baseline before the participant is introduced to the CogMed® training program 2. Within 2 weeks of completion of the CogMed® program 3. At 3 months of completion of the CogMed® program to establish maintenance of gains 4. At 6 months of completion of the CogMed® program to establish longer-term maintenance of gains

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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.

  PMID: 34491526 DERIVED

MeSH Terms

Conditions

Glioma; Brain Neoplasms; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ashlee Loughan, PhD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 27, 2017
• Study Start: October 20, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

US (1)