Cognitive Remediation Therapy for Brain Tumor Patients: Improving Working Memory

NCT ID: NCT03323450

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-20
• Study Completion Date: 2020-06-01

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.

Conditions

Glioma; Brain Tumor, Primary

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CogMed®

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

CogMed®

Intervention Type: 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

Interventions

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):

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashlee Loughan, PhD

Role: PRINCIPAL_INVESTIGATOR

Massey Cancer Center

Locations

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34491526 (View on PubMed)

Other Identifiers

MCC-17-13581

Identifier Type: -

Identifier Source: org_study_id