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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Emily J Amsden, BS
- Numéro de téléphone: 215-316-2343
- E-mail: amsden@kennedykrieger.org
Lieux d'étude
-
-
Maryland
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Baltimore, Maryland, États-Unis, 21205
- Kennedy Krieger Institute
-
Contact:
- Emily J Amsden, BS
- Numéro de téléphone: 215-316-2343
- E-mail: amsden@kennedykriger.org
-
Chercheur principal:
- Rachel K Peterson, PhD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility - Enrollment
Délai: Up to 5 years after diagnosis.
|
Study enrollment rate. |
Up to 5 years after diagnosis.
|
|
Feasibility - Participant Retention
Délai: 8 weeks
|
Number of participants who complete the computerized brain training program. |
8 weeks
|
|
Feasibility - Intervention Adherence
Délai: 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
Délai: 8 weeks
|
Total time spent completing the cognitive training program exercises. |
8 weeks
|
|
Acceptability
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cognitive Training Task-Based Performance
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Rachel K Peterson, PhD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00519695
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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