NCT06922201Not yet recruiting
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
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.
Inclusion criteria
• Minimum Age: Students must be at least 14 years old at the time of enrolment. • Mobile Device and Internet Access: Students must have access to a smartphone and the Internet. • Informed Consent: Students must provide their signed informed consent to participate in the study. • Parental Consent: Students must obtain and submit signed informed consent from a parent or legal guardian.
Exclusion criteria
• Age Restrictions: Students who are younger than 14 years or older than the established age range for participation. • Consent Issues: Students who have not signed the informed consent form or do not have signed informed consent from their parents or legal guardians. • Follow-up Limitations: Students who are unable to commit to the follow-up period of at least 18 months or are unlikely to complete the study.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Not yet recruiting
- Phase
- No phase (N/A)
- Study type
- Interventional
- Countries
- Switzerland, Italy, Belgium, Cyprus, Greece, Romania, Slovenia, Spain
- Sponsor
- Biobizkaia Health Research Institute(Other government)
- Protocol no.
- SUNRISE_Study1
- Conditions
- Cancer
- Interventions
- Other
Treatments studied
- SmartCoach
Collaborators
University Ghent, FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA, Hellenic Mediterranean University, University of Zurich, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana, Cyprus Association of Cancer Patients and Friends (PASYKAF), Alma Mater Europaea - Slovenia, The Oncology Institute "Prof. Dr. Ion Chiricuţă" Cluj-Napoca
Locations · 8
- Zurich, SwitzerlandSwiss Research Institute for Public Health and Addiction (ISGF)Not yet recruiting at this site
- Roma, ItalyItalian Federation of Voluntary Associations in Oncology (FAVO)Not yet recruiting at this site
- Ghent, BelgiumGhent University (UGENT)Not yet recruiting at this site
- Nicosia, CyprusCyprus Association of Cancer Patients and Friends (PASYKAF)Not yet recruiting at this site
- Heraklion, GreeceHellenic Mediterranean University (HMU)Not yet recruiting at this site
- Cluj-Napoca, RomaniaInstitute of Oncology "Prof dr. Ion Chiricuta" CLUJ NAPOCA (IOCN)Not yet recruiting at this site
- Maribor, SloveniaAlma Mater Europaea University (AMEU)Not yet recruiting at this site
- Valencia, SpainFoundation for the Promotion of Health and Biomedical Research of the Valencian Community (FisabioNot yet recruiting at this site
In total, worldwide, all 8 sites listed in the registry are planned; recruitment has not opened yet.
Site status per the ClinicalTrials.gov registry (last update posted: April 10, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.