Brain Tumor, PediatricNCT07558473
Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors
A study testing Online computerized cognitive training intervention focused on processing speed. in people with Brain Tumor, Pediatric, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Brain Tumor, Pediatric
- What is being tested?
- Online computerized cognitive training intervention focused on processing speed.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2026to 1 Apr 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Emily J Amsden, BS, 215-316-2343, amsden@kennedykriger.org
Rachel K Peterson, PhD
About this study
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:
- Is the cognitive intervention feasible to administer to children with brain tumors during and after cancer treatment?,
- Is the cognitive intervention acceptable to children and caregivers?, and
- Does the cognitive intervention improve neuropsychological functioning?
Read more
There is no comparison group for this study.
Participants will:
- Complete an online computerized cognitive training program for approximately 15 minutes per day, 5 days a week, for 8 weeks;
- Have weekly check-ins with the cognitive coach,
- Complete a survey at the end of the cognitive training program, and
- Complete pre- and post- neuropsychological testing.
- Conditions
- Brain Tumor, Pediatric
- Being tested
- Online computerized cognitive training intervention focused on processing speed.
- Keywords
- Brain Tumor, Pediatric, Pediatric Brain Tumor, Cognitive Intervention, Intervention, Oncology, Cancer
- Medical subject headings
- Brain Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online computerized cognitive training intervention focused on processing speed.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Intervention | Experimental | Computerized cognitive training program focused on processing speed. Receives: Behavioral: Online computerized cognitive training intervention focused on processing speed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Enrollment
Study enrollment rate.
Measured: Up to 5 years after diagnosis.
Feasibility - Participant Retention
Number of participants who complete the computerized brain training program.
Measured: 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.
Measured: Through study completion, an average of 8 weeks.
Feasibility - Total Intervention Time
Total time spent completing the cognitive training program exercises.
Measured: 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.
Measured: At the end of the 8-week intervention.
Secondary outcomes (4)
Cognitive Training Task-Based Performance
Changes in neuropsychological functioning, as measured by the train-to-task activity.
Measured: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
Processing Speed
Changes in processing speed as measured by the NIH toolbox.
Measured: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
Attention
Changes in attention as measured by the NIH toolbox.
Measured: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
Working Memory
Changes in working memory as measured by the NIH toolbox.
Measured: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Jul 2031 (estimated)
- Study completion1 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brain Tumor, PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel K Peterson, PhD, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558473
- Sponsor's protocol ID
- IRB00519695
- Status last verified
- Aug 2026
- First submitted
- 19 Mar 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29128897Maeir 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.
PubMed 36746805Areklett 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.
PubMed 39576570Jacola 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.
PubMed 40635330
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors
- ClinicalTrials.gov ID
- NCT07558473
- Acronym / sponsor ID
- IRB00519695
- Conditions
- Brain Tumor, Pediatric
- Keywords
- Brain Tumor, Pediatric, Pediatric Brain Tumor, Cognitive Intervention, Intervention, Oncology, Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Jul 2031 (estimated)
- Study completion
- 1 Apr 2033 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the cognitive intervention feasible to administer to children with brain tumors during and after cancer treatment?,
- Is the cognitive intervention acceptable to children and caregivers?, and
- Does the cognitive intervention improve neuropsychological functioning?
There is no comparison group for this study.
Participants will:
- Complete an online computerized cognitive training program for approximately 15 minutes per day, 5 days a week, for 8 weeks;
- Have weekly check-ins with the cognitive coach,
- Complete a survey at the end of the cognitive training program, and
- Complete pre- and post- neuropsychological testing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Intervention | Experimental | Behavioral: Online computerized cognitive training intervention focused on processing speed.Computerized cognitive training program focused on processing speed. |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online computerized cognitive training intervention focused on processing speed.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. | Behavioural | Cognitive Intervention |
Primary outcome
Feasibility - Enrollment
Time frame: Up to 5 years after diagnosis.
Study enrollment rate.
Feasibility - Participant Retention
Time frame: 8 weeks
Number of participants who complete the computerized brain training program.
Feasibility - Intervention Adherence
Time frame: Through study completion, an average of 8 weeks.
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.
Feasibility - Total Intervention Time
Time frame: 8 weeks
Total time spent completing the cognitive training program exercises.
Acceptability
Time frame: At the end of the 8-week intervention.
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.
4 secondary outcomes
Cognitive Training Task-Based Performance
Time frame: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
Processing Speed
Time frame: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
Attention
Time frame: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
Working Memory
Time frame: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 29128897Meneses 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.
- Background: PubMed 36746805Maeir 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.
- Background: PubMed 39576570Areklett 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.
- Background: PubMed 40635330Jacola 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel K Peterson, PhD principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online computerized cognitive training intervention focused on processing speed. in people with Brain Tumor, Pediatric, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily J Amsden, BS (215-316-2343, amsden@kennedykrieger.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Enrollment (time frame: Up to 5 years after diagnosis.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07558473, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.