protocolSection identificationModule nctId: NCT06312969, orgStudyIdInfo id: 2022.301, briefTitle: Technological Gaming in Cancer Survivors (WINNERS), acronym: WINNERS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-23, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Antonio Pérez Martínez, class: OTHER, collaborators name: Hospital Ruber Internacional, collaborators name: Universidad Rey Juan Carlos, descriptionModule briefSummary: HYPOTHESIS1. Neurocognitive deficits in cancer survivors are underestimated. They represent a very limiting long-term side effect in this group of patients.2. An individualized, planned and limited intervention using technological gaming can improve neurocognitive function in these pediatric patients by taking advantage of the plasticity of the central nervous system (CNS) in the pediatric age.3. Changes can be demonstrated not only at the cognitive level, but also at the structural and functional level using neuroimaging techniques after our intervention.4. In addition to the aforementioned benefits, this therapeutic tool can improve some clinical-analytical markers used in the follow-up of cancer survivors, such as immunological markers like lymphocyte populations and inflammatory cytokines.5. The neurocognitive effects of this therapy are not only produced at the time of the intervention, but remain until months after the intervention.6. The positive impact of the treatment is not only observed in the patients, but also in the psychological and emotional state of the family members.VARIABLES1. Clinically relevant improvement with moderate or large effect size in the following parameters as measured by neuropsychological tests.2. Statistically significant changes in neuroimaging tests.3. Statistically significant changes in immune and inflammatory biomarkers before and after treatment.STUDY DESIGN In this clinical trial, randomized versus control group, unblinded, the aim is to demonstrate the neuropsychological, structural and functional benefit of an intervention using video games in child cancer survivors.POPULATION OF THE STUDY The target population participating in the study will include patients of either sex aged 8-17 years who completed cancer treatment 1-5 years ago. They must have received treatment with neurotoxic potential: intrathecal/intraventricular chemotherapy, high-dose chemotherapy with crossing of the blood-brain barrier, CNS radiotherapy or hematopoietic stem cell transplantation (HSCT)., conditionsModule conditions: Survivors of Childhood Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized versus control group clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Video game based training, outcomesModule primaryOutcomes measure: SDMT Test, primaryOutcomes measure: Change in SDMT Test, primaryOutcomes measure: Change in SDMT Test, primaryOutcomes measure: "DIGITOS" Test, primaryOutcomes measure: Change in "DIGITOS" Test, primaryOutcomes measure: Change in "DIGITOS" Test, primaryOutcomes measure: "TONI-4" test, primaryOutcomes measure: Change in "TONI-4" test, primaryOutcomes measure: Change in "TONI-4" test, primaryOutcomes measure: "ROCF" test, primaryOutcomes measure: Change in "ROCF" test, primaryOutcomes measure: Change in "ROCF" test, primaryOutcomes measure: "TFV" test, primaryOutcomes measure: Change in "TFV" test, primaryOutcomes measure: Change in "TFV" test, primaryOutcomes measure: "STROOP" test, primaryOutcomes measure: Change in "STROOP" test, primaryOutcomes measure: Change in "STROOP" test, primaryOutcomes measure: "TAVECI" test, primaryOutcomes measure: Change in "TAVECI" test, primaryOutcomes measure: Change in "TAVECI" test, primaryOutcomes measure: "CPT3", primaryOutcomes measure: Change in "CPT3", primaryOutcomes measure: Change in "CPT3", primaryOutcomes measure: "BRIEF" survey, primaryOutcomes measure: Change in "BRIEF" survey, primaryOutcomes measure: Change in "BRIEF" survey, primaryOutcomes measure: "BASC" survey, primaryOutcomes measure: Change in "BASC" survey, primaryOutcomes measure: Change in "BASC" survey, primaryOutcomes measure: Statistically significant changes in neuroimaging tests, primaryOutcomes measure: Statistically significant changes in neuroimaging tests, primaryOutcomes measure: Immune and inflammatory biomarkers, primaryOutcomes measure: Statistically significant changes in immune and inflammatory biomarkers, primaryOutcomes measure: Statistically significant changes in immune and inflammatory biomarkers, secondaryOutcomes measure: Prevalence, secondaryOutcomes measure: Perception of the family measured by satisfaction survey, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hospital La Paz, status: RECRUITING, city: Madrid, zip: 28046, country: Spain, contacts name: Carlos Gonzalez-Perez, MD, role: CONTACT, phone: 0034917277223, email: carlos.gonzalez2@salud.madrid.org, contacts name: Antonio Perez-Martinez, PhD, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Carlos R Gonzalez-Perez, MD, role: SUB_INVESTIGATOR, contacts name: Eduardo Fernandez, PhD, role: SUB_INVESTIGATOR, contacts name: Elena Moran, role: SUB_INVESTIGATOR, contacts name: Juan Alvarez, role: SUB_INVESTIGATOR, contacts name: Norberto Malpica, role: SUB_INVESTIGATOR, contacts name: Diego Plaza, MD, role: SUB_INVESTIGATOR, contacts name: Mario Alonso, role: SUB_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False