Brief Summary

This randomized clinical trial studies how well an adaptive computerized cognitive training program works compared to a non-adaptive computerized cognitive training program in treating younger patients with brain tumor who underwent radiation therapy. Providing a computer training program may improve the well-being and quality of life of patients with cognitive (physical and mental) function difficulties caused by radiation therapy to the brain.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach

2 countries

28 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2011

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2012

Completed

2.6 years until next milestone

Study Start

First participant enrolled

July 30, 2014

Completed

10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed

11 months until next milestone

Results Posted

Study results publicly available

December 5, 2025

Completed

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

10.4 years

First QC Date

December 30, 2011

Results QC Date

November 19, 2025

Last Update Submit

April 3, 2026

Conditions

Recurrent Brain Neoplasm Brain Neoplasm

Outcome Measures

Primary Outcomes (1)

Intervention Compliance
Intervention compliance is defined as at least 80% of computerized training sessions completed (i.e., completing at least 20 sessions within 9 weeks of starting training). Will report the proportion of eligible, randomized patients who meet the compliance definition by arm with corresponding 95% confidence intervals.
Up to 9 weeks of starting training

Other Outcomes (11)

Parent-rated Executive Function Using the Metacognition Subscales From the Behavior Rating Inventory of Executive Function (BRIEF)
Up to 6 months post training completion
Working Memory (WM) Using the Metacognition Subscales From (BRIEF)
Up to 6 months post training completion
Executive Function Using the Groton Maze Learning Task of the CogState Battery
Up to 6 months post training completion
+8 more other outcomes

Study Arms (2)

Arm I (interactive training program)

EXPERIMENTAL

Patients undergo a home-based, computerized, interactive training program comprising 3-5 sessions of 15-45 minutes every week for 5-9 weeks. The program contains twelve visually engaging and interesting exercises that target skills involving visual-spatial and verbal WM. The program is adaptive in a way that each difficulty task is automatically adjusted on a trial-by-trail basis to match a patient's current WM. Each patient has an interventional coach who has online access to patient's training sessions and outcomes (pass or fail). Coaches are able to modify the training sequence or make suggestions to patients and/or parents about how progress can be maximized. Coaches also have telephone meetings with patients and/or families once a week to ensure compliance, track progress, provide feedback, and answer questions that arise during training.

Procedure: Cognitive AssessmentOther: Computer-Assisted Cognitive TrainingProcedure: Psychosocial Assessment and CareOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm II (non-adaptive training program)

EXPERIMENTAL

Patients undergo a home-based, computerized, interactive, non-adaptive training program comprising 3-5 sessions of 15-45 minutes a week for 5-9 weeks. Each patient also has an interventional coach as in arm I. Patients in both arms complete a brief neuropsychological/behavioral assessment comprising the WIS-IV, the CMS, and the CVLT-C at baseline, after completion of study, and at 6 months after completion of study. Additionally, parents complete a parent-report questionnaire to gather information about patient's behaviors, thoughts, emotions, adaptive skills, and social and functional impairment. Parents and children also complete surveys about the program regarding technical feasibility, adherence, ease-of-use, and satisfaction.

Procedure: Cognitive AssessmentOther: Computer-Assisted Cognitive TrainingProcedure: Psychosocial Assessment and CareOther: Quality-of-Life AssessmentOther: Questionnaire Administration