Study protocol for a randomized controlled clinical trial of a multifaceted cognitive training program using video games in childhood cancer survivors

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Detalles Bibliográficos
Publicado en:	PLoS One vol. 20, no. 9 (Sep 2025), p. e0314118
Autor principal:	González-Pérez, Carlos
Otros Autores:	Melero, Helena, Malpica, Norberto, Álvarez-Linera, Juan, Mario Alonso Puig, Plaza, Diego, Pérez-Martínez, Antonio
Publicado:	Public Library of Science
Materias:	Food & Drug Administration > FDA Spain Neurotoxicity Neuroimaging Training Intervention Radiation therapy Stem cells Neuropsychology Central nervous system Verbal learning Pediatrics Medical diagnosis Hematopoietic stem cells Chemotherapy Hemopoiesis Complications Lymphocytes Solid tumors Quality of life Transplantation Tumors Patients Population studies Allografts Computer & video games Cognition Leukemia Epilepsy Disease Cancer therapies Medical imaging Survival Immunology Oncology Attention deficit hyperactivity disorder Inflammation Children Stem cell transplantation Cancer Clinical trials Perception Biomarkers Informed consent Structure-function relationships Hematological diseases Malignancy Executive function Childhood Social
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Descripción
Resumen:	This randomized controlled trial aims to evaluate the efficacy of a cognitive training program using video games in improving neuropsychological, neurological, immunological, and inflammatory parameters in childhood cancer survivors. This study will recruit 56 patients aged 8–17 years who have completed cancer treatment 1–8 years prior to enrollment. Participants will be randomized to either the video game intervention or waiting group. The primary objectives are analyzing potential changes in neuropsychological tests covering all neurocognitive domains, neuroimaging tests (structural, diffusion, and functional imaging), and immune and inflammatory biomarker levels after video game intervention. The secondary objectives are to define the prevalence of neurocognitive deficits in the study population, analyze psychological and emotional self-perception and parental perception after the intervention, and assess the feasibility of implementing this new intervention methodology. The inclusion criteria comprise specific diagnoses (central nervous system [CNS] cancer, hematologic malignancies, extracranial solid tumors, and nonmalignant hematological diseases requiring allogeneic hematopoietic progenitor transplantation) and treatments (CNS surgery, radiotherapy, intrathecal/intraventricular chemotherapy, neurotoxic systemic chemotherapy, and hematopoietic stem cell transplantation). Patients with active disease, relapse, or prior neurological or psychiatric pathology will be excluded. This study will improve the understanding and management of neurocognitive sequelae in childhood cancer survivors and ultimately enhance their quality of life. Trial identifier: NCT06312969
ISSN:	1932-6203
DOI:	10.1371/journal.pone.0314118
Fuente:	Health & Medical Collection