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

ConditionCancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-18
SponsorBiobizkaia Health Research Institute

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SmartCoach

    Other intervention

    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).

Treatment groups

3,500 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Point prevalence rate of tobacco or nicotine use

This will be measured by assessing the rate of abstinence (not even smoked a puff or used once) from tobacco or nicotine products in the preceding 30 days.

Time frame
The primary outcomes will be assessed at baseline, 6 months, and 18 months follow-up

Secondary outcomes

1

Frequency of tobacco cigarette smoking

Determined by the number of days on which tobacco cigarettes were smoked in the last 30 days

Time frame
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
2

Prevalence and frequency of other nicotine products use

Determined by the number of days on which other nicotine products, e.g., vape, e-cigarette, e-shisha, snus or nicotine pouches, were consumed in the last 30 days

Time frame
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
3

Prevalence and frequency of cannabis use

Measured by the number of cannabis (containing THC) consumption days in the preceding 30 days

Time frame
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
4

Prevalence and frequency of alcohol use

Assessed by the number of alcohol use days in the preceding 30 days

Time frame
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biobizkaia Health Research Institute

Lead sponsor

University Ghent

Collaborator

FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA

Collaborator

Hellenic Mediterranean University

Collaborator

University of Zurich

Collaborator

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

Collaborator

Cyprus Association of Cancer Patients and Friends (PASYKAF)

Collaborator

Alma Mater Europaea University

Collaborator

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

Collaborator

This trial is not recruiting at the moment. You can still explore other options: