Clinical Trial

The SUNRISE Project is Dedicated to Enhancing Primary Cancer Prevention Among Adolescents in Europe by Leveraging Innovative Digital Tools and Methodologies. SmartCoach, Developed by Swiss Research Institute for Public Health and Addiction (ISGF), is a Mobile Phone-based Life-skills Training Program

Study acronym: SUNRISE_1
Not Yet Recruiting
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Summary
SUNRISE aims to create a comprehensive, engaging, and sustainable digital health promotion program that not only addresses immediate health behaviours but also instills lifelong healthy habits among adolescents. By integrating cutting-edge digital tools with traditional educational settings, SUNRISE seeks to bridge the gap between knowledge and practice, making cancer prevention a tangible and achievable goal for young people. This study represents a significant step towards reducing the future burden of cancer through early and innovative preventive measures. The SUNRISE project aims to test its intervention on students across eight European countries, including Greece, Switzerland, Slovenia, Spain, Cyprus, Italy, Belgium, and Romania. This study focuses on integrating digitally enhanced programs into the school environment, targeting students aged 10 to 19 years. The program emphasizes inclusivity, ensuring participation from both urban and rural regions and socially disadvantaged groups such as ethnic minorities and migrants. By addressing diverse socio-economic, cultural, and environmental contexts, SUNRISE aspires to create a universally applicable and impactful intervention. Specifically, this study is focus on the SmartCoach program, developed by the Swiss Research Institute for Public Health and Addiction (ISGF). It is a mobile phone-based life-skills training program designed to prevent substance use among adolescents. It will integrate digital tools and leveraging social media creating a more engaging, effective and sustainable intervention for adolescent health behaviour change. The SmartCoach solution will be significantly more effective than an assessment-only approach in preventing the initiation and escalation of problematic alcohol and tobacco use. This efficacy will be demonstrated through a two-arm cluster-randomized controlled trial, with participants assessed at baseline, 6 months, and 18 months. The study will measure key outcomes related to substance use frequencies, intensities, and associated behavioral changes, showing that the individually tailored 4 month intervention program leads to greater reductions in these behaviors compared to the control group over the 18-month follow-up period.
Trial Details
NCT Number NCT06922201
Lead Sponsor Biobizkaia Health Research Institute
Collaborators: University Ghent, FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA, Hellenic Mediterranean University, University of Zurich, FISABIO (Foundation for the Promotion of Healthcare and Biomedical Research in the Valencian Community), Cyprus Association of Cancer Patients and Friends (PASYKAF), Alma Mater Europaea - Slovenia, The Oncology Institute "Prof. Dr. Ion Chiricuţă" Cluj-Napoca
Conditions Cancer
Enrollment 3,500 participants
Start Date 2025-09
Primary Completion 2027-03 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2025-04-10