Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors
4. august 2026 opdateret af: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
300
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Emily J Amsden, BS
- Telefonnummer: 215-316-2343
- E-mail: amsden@kennedykrieger.org
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21205
- Kennedy Krieger Institute
-
Kontakt:
- Emily J Amsden, BS
- Telefonnummer: 215-316-2343
- E-mail: amsden@kennedykriger.org
-
Ledende efterforsker:
- Rachel K Peterson, PhD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Cognitive Intervention
Computerized cognitive training program 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility - Enrollment
Tidsramme: Up to 5 years after diagnosis.
|
Study enrollment rate.
|
Up to 5 years after diagnosis.
|
|
Feasibility - Participant Retention
Tidsramme: 8 weeks
|
Number of participants who complete the computerized brain training program.
|
8 weeks
|
|
Feasibility - Intervention Adherence
Tidsramme: 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.
|
Through study completion, an average of 8 weeks.
|
|
Feasibility - Total Intervention Time
Tidsramme: 8 weeks
|
Total time spent completing the cognitive training program exercises.
|
8 weeks
|
|
Acceptability
Tidsramme: 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.
|
At the end of the 8-week intervention.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cognitive Training Task-Based Performance
Tidsramme: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
Changes in neuropsychological functioning, as measured by the train-to-task activity.
|
Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
|
Processing Speed
Tidsramme: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
Changes in processing speed as measured by the NIH toolbox.
|
Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
|
Attention
Tidsramme: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
Changes in attention as measured by the NIH toolbox.
|
Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
|
Working Memory
Tidsramme: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
Changes in working memory as measured by the NIH toolbox.
|
Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Rachel K Peterson, PhD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
30. juli 2026
Primær færdiggørelse (Anslået)
30. juli 2031
Studieafslutning (Anslået)
1. april 2033
Datoer for studieregistrering
Først indsendt
19. marts 2026
Først indsendt, der opfyldte QC-kriterier
23. april 2026
Først opslået (Faktiske)
30. april 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00519695
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