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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 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 in children with pediatric brain tumors. 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 patients and caregivers? 3. Does the cognitive intervention improve neuropsychological functioning?

There is no comparison group for this study.

Participants will:

1. Complete 15 minutes of online computerized cognitive training 5 times a week for 8 weeks. 2. Have weekly check-ins with the cognitive coach. 3. Fill out acceptability surveys at the end of the cognitive intervention. 4. Complete pre- and post- neuropsychological testing.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a primary tumor located in the brain

Diagnosed between 0 and 25 years of age

Within five years of cancer diagnosis

Receiving care at Johns Hopkins Hospital

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Online computerized cognitive training intervention focused on processing speed.

    Behavioral

    This online cognitive intervention aims to improve processing speed through individualized, computerized cognitive exercises. A cognitive coach selects a set of cognitive exercises for each participant based on identified needs, cognitive ability, and age. Participants complete 15 minutes of training, 5 times per week for 8 weeks, for a target total of approximately 10 hours of training.

Treatment groups

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

Trial outcomes

Primary outcomes

1

Platform Engagement - Logins

Total number of logins recorded over the intervention period.

Time frame
8 weeks
2

Platform Engagement - Task Completion

Total number of completed cognitive training levels

Time frame
8 weeks
3

Engagement Barriers

Participant-reported engagement and barriers measured using a Likert-scale questionnaire administered weekly during the intervention. Mean total score will be reported. Qualitative feedback regarding barriers and facilitators to engagement will also be collected to provide descriptive context.

Time frame
Weekly during 8-week intervention
4

Acceptability

Participant-reported acceptability measured using a Likert-scale questionnaire administered at the end of the intervention. Mean total score will be reported. Qualitative feedback regarding participant experience will also be collected to provide descriptive context.

Time frame
Week 8

Secondary outcomes

1

Performance-based Cognitive Functioning

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.
2

Parent and Self-report Measures of Cognitive Functioning

Change in cognitive functioning as measured by the PROMIS Cognitive Function Child and Parent Proxy surveys

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

Other outcomes

Sponsors and contacts

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