Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-25
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.

About this trial

The goal of this study is to learn if an online computerized training program improves processing speed, attention, and working memory in children with a primary brain tumor during and after active cancer treatment. The main questions it aims to answer are:

1. Is the cognitive intervention feasible to administer to children with brain tumors during and after cancer treatment?, 2. Is the cognitive intervention acceptable to children and caregivers?, and 3. Does the cognitive intervention improve neuropsychological functioning?

There is no comparison group for this study.

Participants will:

1. Complete an online computerized cognitive training program for approximately 15 minutes per day, 5 days a week, for 8 weeks; 2. Have weekly check-ins with the cognitive coach, 3. Complete a survey at the end of the cognitive training program, and 4. Complete pre- and post- neuropsychological testing.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of a primary brain tumor,

Children and young adults 5 to 25 years of age at the time of enrollment,

Within five years of initial brain tumor diagnosis,

Receiving care through the Johns Hopkins neuro-oncology program.

Disqualifiers

Significant visual, hearing, motor, or cognitive impairment that precludes participation in computerized cognitive training program;

Acute medical status (e.g., significant risk for mortality within 3-months of diagnosis).

Trial design

Design model

Single group

Treatments tested in this trial

  • Online computerized cognitive training intervention focused on processing speed.

    Behavioral

    This online cognitive training program aims to improve processing speed through computerized cognitive exercises. Participants will complete approximately 15 minutes of training, 5 days per week for 8 weeks. Weekly check-ins with a cognitive coach will assist with engagement and problem solve any barriers.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Cognitive InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility - Enrollment

Study enrollment rate.

Time frame
Up to 5 years after diagnosis.
2

Feasibility - Participant Retention

Number of participants who complete the computerized brain training program.

Time frame
8 weeks
3

Feasibility - Intervention Adherence

Number of levels completed in the cognitive training program. Qualitative feedback regarding barriers and facilitators to engagement will also we collected to provide descriptive context.

Time frame
Through study completion, an average of 8 weeks.
4

Feasibility - Total Intervention Time

Total time spent completing the cognitive training program exercises.

Time frame
8 weeks

Secondary outcomes

1

Cognitive Training Task-Based Performance

Changes in neuropsychological functioning, as measured by the train-to-task activity.

Time frame
Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
2

Processing Speed

Changes in processing speed as measured by the NIH toolbox.

Time frame
Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
3

Attention

Changes in attention as measured by the NIH toolbox.

Time frame
Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
4

Working Memory

Changes in working memory as measured by the NIH toolbox.

Time frame
Prior to the intervention, immediately following intervention, and 6 months after intervention completion.

Other outcomes

Sponsors and contacts

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