Strengthening cancer prevention in european schools: a randomized controlled trial of digital interventions in adolescents: the SUNRISE program.
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BACKGROUND: Cancer remains a leading cause of mortality worldwide, with a substantial proportion of cases attributable to modifiable lifestyle-related risk factors that emerge during adolescence and often persist into adulthood. Despite the importance of this developmental period for habit formation, evidence on scalable, theory-driven, and sustainable school-based prevention interventions remains limited. The SUNRISE project addresses this gap by evaluating a co-created, digitally supported life-skills programme designed for routine school settings. METHODS: SUNRISE is a pragmatic, multinational, cluster randomised controlled trial conducted in approximately 80 primary and secondary schools across eight European countries (Greece, Switzerland, Slovenia, Spain, Cyprus, Italy, Belgium, and Romania), recruiting around 4,000 students. Classes are randomised at the class level (3:1) to either a six-month digitally enhanced life-skills intervention or standard education. The primary aim of the study is to evaluate the feasibility, implementation, and sustainability of the intervention in real-world school settings, with secondary exploratory assessment of behavioural outcomes. The intervention integrates multiple digital components, including a mobile-based life-skills coaching programme, a conversational assistant, educational and serious games, influencer-led media literacy content, moderated social interaction platforms, and teacher-led educational modules. Intervention design is guided by the Capability-Opportunity-Motivation Behaviour (COM-B) model and developed through systematic co-creation with students, educators, parents, public health experts, and policymakers within a School Living Lab framework. Feasibility, implementation, and sustainability are evaluated using the RE-AIM and PRISM frameworks. Secondary behavioural outcomes include substance use, dietary and physical activity behaviours, mental well-being, stress, social skills, critical thinking towards media and advertising, and critical coping with food-related information, assessed at baseline, 6 months, and 18 months. DISCUSSION: SUNRISE integrates behavioural science, participatory design, and digital innovation to address adolescent health behaviours in real-world educational contexts. By embedding implementation and sustainability evaluation alongside behavioural outcomes, the study aims to generate actionable evidence on how multi-component digital interventions can be adopted, adapted, and maintained across diverse school systems. Findings are expected to inform future large-scale, theory-driven, equitable, and sustainable cancer prevention strategies targeting adolescents across Europe. TRIAL REGISTRATION: NCT06931847 (registration date: 2025-04-09).