Clinical trial NCT03323450: 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
Overall status: COMPLETED
Phase: NA
Conditions: Glioma
Brain Tumor, Primary
Keywords: High grade gliomas (WHO grade III or IV)
Low grade gliomas (WHO Grade II)
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Treatment enrollment rates
timeFrame: 6 months
measure: Attrition rates
timeFrame: 6 months
measure: Change in scores on Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) over time
timeFrame: Baseline to 6 months
measure: Change in scores on Conners' Continuous Performance Test - Third Edition (CPT-3) over time
timeFrame: Baseline to 6 months
measure: Change in scores on Delis-Kaplan Executive Function System (D-KEFS) over time
timeFrame: Baseline to 6 months
measure: Change in scores on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS-Update A, B, C, or D) over time
timeFrame: Baseline to 6 months
measure: Scores on Test of Premorbid Functioning (TOPF) at baseline
timeFrame: Baseline
measure: Change in scores on Trial Making Test (TMT) over time
timeFrame: Baseline to 6 months
measure: Change in scores on Wechsler Memory Scale - Fourth Edition (WMS-IV) over time
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in scores on Beck Anxiety Inventory (BAI) over time
timeFrame: Baseline to 6 months
measure: Change in scores on Beck Depression Inventory-II (BDI-II) over time
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Massey Cancer Center
name: Ashlee Loughan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.