NCT07558473

Brief Summary

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. 1.Is the cognitive intervention feasible to administer to children with brain tumors during and after cancer treatment?
  2. 2.Is the cognitive intervention acceptable to patients and caregivers?
  3. 3.Does the cognitive intervention improve neuropsychological functioning?
  4. 4.Complete 15 minutes of online computerized cognitive training 5 times a week for 8 weeks.
  5. 5.Have weekly check-ins with the cognitive coach.
  6. 6.Fill out acceptability surveys at the end of the cognitive intervention.
  7. 7.Complete pre- and post- neuropsychological testing.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
84mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

May 6, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2031

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2033

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

5 years

First QC Date

March 19, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

Brain TumorPediatricPediatric Brain TumorCognitive InterventionInterventionOncologyCancer

Outcome Measures

Primary Outcomes (4)

  • Platform Engagement - Logins

    Total number of logins recorded over the intervention period.

    8 weeks

  • Platform Engagement - Task Completion

    Total number of completed cognitive training levels

    8 weeks

  • 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.

    Weekly during 8-week intervention

  • 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.

    Week 8

Secondary Outcomes (1)

  • Processing speed

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

Study Arms (1)

Cognitive Intervention

EXPERIMENTAL

Computerized cognitive training program focused on processing speed.

Behavioral: Online computerized cognitive training intervention focused on processing speed.

Interventions

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.

Cognitive Intervention

Eligibility Criteria

Age5 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with a primary tumor outside of the brain
  • Patients too young to participate in the cognitive intervention (\<5 years)
  • Patients with severe brain injuries that precludes them from understanding and participating in the cognitive intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Related Publications (4)

  • Meneses K, Benz R, Bail JR, Vo JB, Triebel K, Fazeli P, Frank J, Vance DE. Speed of processing training in middle-aged and older breast cancer survivors (SOAR): results of a randomized controlled pilot. Breast Cancer Res Treat. 2018 Feb;168(1):259-267. doi: 10.1007/s10549-017-4564-2. Epub 2017 Nov 11.

    PMID: 29128897BACKGROUND
  • Maeir T, Makranz C, Peretz T, Odem E, Tsabari S, Nahum M, Gilboa Y. Cognitive Retraining and Functional Treatment (CRAFT) for adults with cancer related cognitive impairment: a preliminary efficacy study. Support Care Cancer. 2023 Feb 7;31(3):152. doi: 10.1007/s00520-023-07611-y.

    PMID: 36746805BACKGROUND
  • Areklett EW, Hagen BI, Stubberud J, Fagereng E, Andersson S, Lindemann K. Digital goal management training for cognitive impairment in cervical cancer survivors-a randomized comparison study. J Cancer Surviv. 2024 Nov 22. doi: 10.1007/s11764-024-01701-4. Online ahead of print.

    PMID: 39576570BACKGROUND
  • Jacola LM, Peterson RK, Oswald-McCloskey KA, Sekely A, Mabbott DJ, Edelstein K. Neuropsychological function in childhood cancer patients and adult survivors of childhood cancer. J Clin Exp Neuropsychol. 2025 Oct;47(8):788-805. doi: 10.1080/13803395.2025.2521018. Epub 2025 Jul 9.

    PMID: 40635330BACKGROUND

MeSH Terms

Conditions

Brain NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Rachel K Peterson, PhD

    Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily J Amsden, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2026

First Posted

April 30, 2026

Study Start

May 6, 2026

Primary Completion (Estimated)

May 6, 2031

Study Completion (Estimated)

April 1, 2033

Last Updated

May 5, 2026

Record last verified: 2026-05

Locations