- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07558473
Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors
19. maj 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 in children with pediatric brain tumors. 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 patients and caregivers?
- Does the cognitive intervention improve neuropsychological functioning?
There is no comparison group for this study.
Participants will:
- Complete 15 minutes of online computerized cognitive training 5 times a week for 8 weeks.
- Have weekly check-ins with the cognitive coach.
- Fill out acceptability surveys at the end of the cognitive intervention.
- 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:
- 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
Exclusion Criteria:
- 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
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 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Platform Engagement - Logins
Tidsramme: 8 weeks
|
Total number of logins recorded over the intervention period.
|
8 weeks
|
|
Platform Engagement - Task Completion
Tidsramme: 8 weeks
|
Total number of completed cognitive training levels
|
8 weeks
|
|
Engagement Barriers
Tidsramme: Weekly during 8-week intervention
|
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
Tidsramme: Week 8
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Performance-based Cognitive Functioning
Tidsramme: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
Changes in processing speed as measured by the NIH toolbox.
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Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
|
Parent and Self-report Measures of Cognitive Functioning
Tidsramme: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
Change in cognitive functioning as measured by the PROMIS Cognitive Function Child and Parent Proxy surveys
|
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)
6. maj 2026
Primær færdiggørelse (Anslået)
6. maj 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)
22. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00519695
Plan for individuelle deltagerdata (IPD)
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