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Completed

NCT Number: NCT03323450

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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):

  • 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 outcomes

  1. Treatment enrollment rates

    Time frame: 6 months

    Determine feasibility and acceptability of the CogMed training program by assessing treatment enrollment

  2. Attrition rates

    Time frame: 6 months

    Determine feasibility and acceptability of the CogMed training program by assessing attrition rates.

  3. Change in scores on Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) over time

    Time frame: 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).

  4. Change in scores on Conners' Continuous Performance Test - Third Edition (CPT-3) over time

    Time frame: 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).

  5. Change in scores on Delis-Kaplan Executive Function System (D-KEFS) over time

    Time frame: 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).

  6. Change in scores on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS-Update A, B, C, or D) over time

    Time frame: 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).

  7. Scores on Test of Premorbid Functioning (TOPF) at baseline

    Time frame: 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.

  8. Change in scores on Trial Making Test (TMT) over time

    Time frame: 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).

  9. Change in scores on Wechsler Memory Scale - Fourth Edition (WMS-IV) over time

    Time frame: 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).

Secondary outcomes

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

    Time frame: 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 Beck Anxiety Inventory (BAI).

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

    Time frame: 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 Beck Depression Inventory-II (BDI-II).

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 27, 2017
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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