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 1-7 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 (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.
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialNCT06312969
Clinical Protocolshttps://clinicaltrials.gov/ct2/show/NCT06312969
Funding StatementYes
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
This study was reviewed and approved by the Ethics Committee of La Paz University Hospital in Madrid (date of approval: 2022-08-04, institutional code: PI-6221). The study protocol was registered at clinicaltrials.gov (NCT06312969). The patients provided written informed consent to participate in the study.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data AvailabilityNo datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.
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