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Background <p>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.</p> Methods <p>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&#xa0;months, and 18&#xa0;months.</p> Discussion <p>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.</p> Trial registration <p>NCT06931847 (registration date: 2025–04-09).</p>

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Strengthening cancer prevention in european schools: a randomized controlled trial of digital interventions in adolescents: the SUNRISE program

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  • 发表日期：

    2026年6月25日

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  • Maitane Barasoain,
  • Ainara Vélez-del-Burgo,
  • Itziar Astigarraga,
  • Severin Haug,
  • Nikolai Kiselev,
  • Kleio Koutra,
  • Vassilis Kilintzis,
  • Maria Krini,
  • Theophano Pampaka,
  • Liselot Hudders,
  • Eline De Keyzer,
  • Polonca Serrano,
  • Chiara Pilotti,
  • Laura Del Campo,
  • Delia Nicoara,
  • Niculina Nicoara,
  • Ana Molina-Barceló,
  • Teresa de Pablo Pardo,
  • Stefanie Verduyn,
  • Gloria Cea,
  • Chrysoula Katsapi,
  • Lucas Javier Segal,
  • Iraklis Tsoupouroglou,
  • Bárbara Guerra,
  • Andreas Triantafyllidis,
  • Eunate Arana-Arri,
  • Sofia Segkouli,
  • Nikos Laloumis,
  • Anastasios Alexiadis,
  • Evdoxia-Eirini Lithoxoidou,
  • Aggeliki Spirou,
  • Charalabos Georgiadis,
  • Sotirios Kafetzopoulos,
  • Konstantinos Votis,
  • Dimitrios Tzovaras,
  • Haridimos Kondylakis,
  • Pelekidou Lina,
  • Konstantina Pityanou,
  • Katerina Micheli,
  • Rafaela Samara,
  • Theocharis Konstantinidis,
  • Evaggelia Maniadi,
  • Evangelos Markakis,
  • Charikleia Tziraki,
  • Kostas Marias,
  • Emmanouil Tsiknakis,
  • Nicolas Philippou,
  • Stavri Xydia,
  • Marisa Ferentinou,
  • Steffi DeJans,
  • Dieneke Van de Sompel,
  • Emma Beuckels,
  • Hayley Pearce,
  • Tania Schreiner,
  • Yvette Albert,
  • David Bogataj,
  • Anja Inkret,
  • Nandu Goswami,
  • Panagiotis Bamidis,
  • Sofia Reppou,
  • Dimitrios Spachos,
  • Alba Gallego,
  • Irene Mallo,
  • Eduardo Buhid,
  • Giuseppe Fico,
  • María Fernanda Cabrera,
  • Francisco Lupianez Villanueva,
  • Justine Van der Feen,
  • Nick Dietrich,
  • Ana Roca-Umbert,
  • Marco Manso,
  • Jose Pires,
  • Mercedes Vanaclocha,
  • Paula Romeo,
  • Belen Manyogil,
  • Mireia Gandia,
  • Óscar García,
  • Erika Marulanda,
  • Rachele Valentinotti,
  • Elisabetta Iannelli,
  • Francesco De Lorenzo,
  • Davide De Persis,
  • Alice Summa,
  • Álvaro Sánchez Pérez,
  • Enrique Peiro Callizo,
  • Janire Orcajo-Lago,
  • Susana Meijide,
  • Jon Eneko Idoyaga-Uribbarrena,
  • Verónica Gómez-Sánchez,
  • Haizea Martín-Rodríguez,
  • Macarena de Bareño,
  • Marta Llarena,
  • Vassilis Liakopoulos,
  • Maria Panagopoulou,
  • Giorgos Mavromanolakis,
  • Maria Manteli,
  • Pavlos Koulouris,
  • Sofoklis Sotiriou,
  • Loes Neven,
  • Katie Rizvi,
  • Oana Rusu,
  • Diana Todea,
  • Laura Cristea,
  • Cristina Trifulescu,
  • Andreas Wenger,
  • Niko Boumparis,
  • Olivia Studhalter,
  • Katrina Champion,
  • Maree Teesson,
  • Nicola Newton

摘要

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).