protocolSection identificationModule nctId: NCT06321016, orgStudyIdInfo id: 2023111039, briefTitle: POZIKIDS: Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer, acronym: PoziKids, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Nere Mendizabal, class: OTHER_GOV, descriptionModule briefSummary: Objective: To assess the feasibility of a supervised, controlled and personalised physical exercise programme and its potential efficacy in improving functional capacity and quality of life in children and adolescents with cancer.Design: Hybrid quasi-experimental pilot trial, clinical and phase I implementation.Methods: The learning collaborative approach based on the Institute for Healthcare Improvement Breakthrough Series Collaborative Model will be followed through quarterly Plan-Do-Study-Act (P-D-S-A) cycles. Participants: For feasibility, at least, 45 patients will be included in 3 successive PDSA cycles of at least 15 patients each, aged 4-18 years diagnosed with any type of cancer. Variables: clinical and socio-demographic, body composition, physical condition and mobility, quality of life, physical activity and implementation. Intervention: Everyone will receive a physical exercise intervention combining strength and aerobic capacity work. Initially it will be carried out in the hospital setting, and later in streaming supervised by a professional. The intervention will be modelled through a formative evaluation process with the collaboration of all the agents involved, experimenting in each cycle with an increasingly adapted version of the exercise programme.Statistical analysis: Recruitment rates will be calculated, characteristics associated with project participation and adherence to the exercise programme will be identified. Outcome variables will be compared before and after the intervention, identifying those with the greatest validity, reliability and sensitivity to change, which will then be used in phase II and III trials., conditionsModule conditions: Exercise, conditions: Childhood Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Physical exercise program, interventions name: Type of the physical exercise program, outcomesModule primaryOutcomes measure: Quarterly recruitment rates assessed by comparing those who participate with those who do not., primaryOutcomes measure: Adherence rates assessed by the proportion of sessions completed and adherence to the prescribed exercise protocol, primaryOutcomes measure: Body composition assessed by the Body Mass Index, primaryOutcomes measure: Muscle mass, primaryOutcomes measure: Bone mineral density, primaryOutcomes measure: Physical condition assessed by the 6 min walking test and manual grip test with a dynamometer, primaryOutcomes measure: Muscular strength assessed by manual grip test with a dynamometer, primaryOutcomes measure: General Quality of life assessed by the PedsQL 4.0 questionnaire, primaryOutcomes measure: Specific Quality of life assessed by the PedsQL cancer questionnaire, primaryOutcomes measure: Fatigue assessed by the PedsQL Multidimensional Fatigue Scale Acute Version (PedsQL-MFS), primaryOutcomes measure: Physical activity level assessed by accelerometers, secondaryOutcomes measure: Security assessment, secondaryOutcomes measure: Costs associated estimation, secondaryOutcomes measure: Implementation barriers and facilitators, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False