Cognitive Remediation Therapy for Brain Tumor Patients: Improving Working Memory

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Glioma; Brain Tumor, Primary

Treatments: Behavioral: CogMed®

Study type: Interventional

Funder types: Other

Identifiers

NCT03323450

MCC-17-13581

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

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

Experimental group

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.

Treatment:

Behavioral: CogMed®

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

Experimental group

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.

Treatment:

Behavioral: CogMed®