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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3500

Last updated 2025-04-10

No results posted yet for this 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.

Conditions

Interventions

OTHER

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).

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER
  • FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA

    collaborator UNKNOWN
  • Hellenic Mediterranean University

    collaborator OTHER
  • University of Zurich

    collaborator OTHER
  • FISABIO (Foundation for the Promotion of Healthcare and Biomedical Research in the Valencian Community)

    collaborator UNKNOWN
  • Cyprus Association of Cancer Patients and Friends (PASYKAF)

    collaborator UNKNOWN
  • Alma Mater Europaea University

    collaborator UNKNOWN
  • The Oncology Institute "Prof. Dr. Ion Chiricuţă" Cluj-Napoca

    collaborator UNKNOWN
  • Biocruces Bizkaia Health Research Institute

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-03-31
Completion
2028-04-30

Countries

  • Belgium
  • Cyprus
  • Greece
  • Italy
  • Romania
  • Slovenia
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06922201 on ClinicalTrials.gov