Precision-based exercise protocols for children with cancer: a methodological approach from the European FORTEe research project.
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INTRODUCTION: Children, adolescents and young adults with cancer face severely reduced exercise tolerance while undergoing treatment, which places an additional burden on their health. The FORTEe research project, a European multicenter randomized clinical trial, investigates if a precision-based exercise program (PEx) can reduce cancer-related fatigue and maintain or improve a broad range of physical and psychosocial outcomes, thereby supporting its integration into standard paediatric oncology care from the start of cancer treatment. This methodological paper describes how the protocols were developed, applied in the field, and disseminated within the scientific community. METHODS: One year of consultation between the 10 clinical centers across the FORTEe consortium in Europe lead to the FORTEe precision-based exercise protocols (FORTEe-exprot). They include cardiorespiratory, resistance, flexibility, balance, and coordination training, tailored to age, functional status, and treatment intensity. Sessions are intended to be delivered 3-5 times/week, 20-60 minutes, in inpatient, outpatient, and home settings, with in-person or telehealth supervision. Safety considerations comprised individualized modifications, vital signs monitoring, and structured reporting of adverse events. Daily documentation of exercise type, intensity, duration, and individual perceived exertion informs ongoing prescription adjustments. RESULTS: A final version of the FORTEe-exprot was ready by March 2022, prior to the start of clinical trial recruitment. During their development, potential risks were carefully considered, including injury, staff experience, data quality, recruitment, and compliance. The FORTEe-exprot were designed to be inclusive, accommodating children with varying needs and ensuring applicability across different levels of expertise among exercise professionals and diverse clinical settings. The FORTEe-exprot printed handbooks were disseminated internally and externally via conferences and distribution of around 50 countries worldwide. They are freely downloadable from the FORTEe website and from Zenodo, an open research repository commonly used for EU-funded research projects. DISCUSSION: Effective implementation of PEx requires appropriately trained exercise professionals, risk-stratified prescription, daily documentation, and close interdisciplinary collaboration to ensure safe, individualized interventions aligned with each child's clinical status. Such multi-stakeholder collaboration constituted a key foundation of the FORTEe-exprot, highlighting their potential role in pediatric oncology care and their possible contribution to future evidence-based recommendations.