NCT07558473

Brief Summary

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. 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 children and caregivers?, and
  3. 3.Does the cognitive intervention improve neuropsychological functioning?
  4. 4.Complete an online computerized cognitive training program for approximately 15 minutes per day, 5 days a week, for 8 weeks;
  5. 5.Have weekly check-ins with the cognitive coach,
  6. 6.Complete a survey at the end of the cognitive training program, and
  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
79mo left

Started Jul 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

Study Progress3%
Jul 2026Apr 2033

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
3 months until next milestone

Study Start

First participant enrolled

July 30, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2031

Expected
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2033

Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

5 years

First QC Date

March 19, 2026

Last Update Submit

August 4, 2026

Conditions

Brain Tumor, Pediatric

Keywords

Brain TumorPediatricPediatric Brain TumorCognitive InterventionInterventionOncologyCancer

Outcome Measures

Primary Outcomes (5)

  • Feasibility - Enrollment

    Study enrollment rate.

    Up to 5 years after diagnosis.

  • Feasibility - Participant Retention

    Number of participants who complete the computerized brain training program.

    8 weeks

  • 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.

    Through study completion, an average of 8 weeks.

  • Feasibility - Total Intervention Time

    Total time spent completing the cognitive training program exercises.

    8 weeks

  • Acceptability

    Parent and self-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.

    At the end of the 8-week intervention.

Secondary Outcomes (4)

  • Cognitive Training Task-Based Performance

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

  • Processing Speed

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

  • Attention

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

  • Working Memory

    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

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.

Cognitive Intervention

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

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. 2026 Jun;20(3):978-989. doi: 10.1007/s11764-024-01701-4. Epub 2024 Nov 22.

    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

215-316-2343amsden@kennedykrieger.org

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

July 30, 2026

Primary Completion (Estimated)

July 30, 2031

Study Completion (Estimated)

April 1, 2033

Last Updated

August 7, 2026

Record last verified: 2026-08

Locations

US(1)