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- Klinische proef NCT07558473
Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Emily J Amsden, BS
- Telefoonnummer: 215-316-2343
- E-mail: amsden@kennedykrieger.org
Studie Locaties
-
-
Maryland
-
Baltimore, Maryland, Verenigde Staten, 21205
- Kennedy Krieger Institute
-
Contact:
- Emily J Amsden, BS
- Telefoonnummer: 215-316-2343
- E-mail: amsden@kennedykriger.org
-
Hoofdonderzoeker:
- Rachel K Peterson, PhD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Feasibility - Enrollment
Tijdsspanne: Up to 5 years after diagnosis.
|
Study enrollment rate. |
Up to 5 years after diagnosis.
|
|
Feasibility - Participant Retention
Tijdsspanne: 8 weeks
|
Number of participants who complete the computerized brain training program. |
8 weeks
|
|
Feasibility - Intervention Adherence
Tijdsspanne: 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
Tijdsspanne: 8 weeks
|
Total time spent completing the cognitive training program exercises. |
8 weeks
|
|
Acceptability
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cognitive Training Task-Based Performance
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Rachel K Peterson, PhD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
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Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB00519695
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