🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Belgium / NCT06922201
Starting soon Not applicable

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

NCT06922201 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2025-09
Last updated
2025-04-10

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

SmartCoach

SmartCoach: Participants will receive a tailored life-skills training program over four months, which includes 2-4 personalized messages per week via Whatsapp. These messages, in the form of microdialogues generated by an automated system, will focus on self-management skills, social skills and substance use resistance skills. The program will use interactive elements such as quiz questions, behavioural plans, message contests and multimedia content (audio testimonials, motivational podcasts, videos, images and links to relevant websites).

Study 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.

Eligibility

Sex
ALL
Min age
14 Years
Max age
18 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Ghent University (UGENT) Ghent Belgium
Cyprus Association of Cancer Patients and Friends (PASYKAF) Nicosia Cyprus
Hellenic Mediterranean University (HMU) Heraklion Greece
Italian Federation of Voluntary Associations in Oncology (FAVO) Roma Italy
Institute of Oncology "Prof dr. Ion Chiricuta" CLUJ NAPOCA (IOCN) Cluj-Napoca Romania
Alma Mater Europaea University (AMEU) Maribor Slovenia
Foundation for the Promotion of Health and Biomedical Research of the Valencian Community (Fisabio Valencia Spain
Swiss Research Institute for Public Health and Addiction (ISGF) Zurich Switzerland

More Biobizkaia Health Research Institute trials in Belgium

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06922201 on ClinicalTrials.gov ↗ ← All trials in Belgium