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
SUstaiNable inteRventions and Healthy behavIours for adoleScent Primary prEvention of Cancer With Digital Tools. Study 1: SmartCoach
Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 3500 (estimated)
- First submitted
- 5 Dec 2024
- Start date
- Sept 2025
- Primary completion date
- Mar 2027
- Lead sponsor
- Biobizkaia Health Research Institute
- Diseases
- Childhood cancers
- NCT number
- NCT06922201
What you commit to
- Study type: Interventional
- Planned participants: 3500
- From Sept 2025 to the primary completion date, Mar 2027
- 8 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Age Restrictions: Students who are younger than 14 years or older than the established age range for participation.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 14 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ghent University (UGENT) Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Swiss Research Institute for Public Health and Addiction (ISGF) Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Cyprus Association of Cancer Patients and Friends (PASYKAF) Coordinator of this site? Confirm its status | Nicosia | Cyprus | Unknown status |
| Foundation for the Promotion of Health and Biomedical Research of the Valencian Community (Fisabio) Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hellenic Mediterranean University (HMU) Coordinator of this site? Confirm its status | Heraklion | Greece | Unknown status |
| Italian Federation of Voluntary Associations in Oncology (FAVO) Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Institute of Oncology "Prof dr. Ion Chiricuta" CLUJ NAPOCA (IOCN) Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| Alma Mater Europaea University (AMEU) Coordinator of this site? Confirm its status | Maribor | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.