Clinical trial NCT06922201: 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
Official title: SUstaiNable inteRventions and Healthy behavIours for adoleScent Primary prEvention of Cancer With Digital Tools. Study 1: SmartCoach
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: SUNRISE
SmartCoach
Life-skills training
substance use prevention
adolescents
Lead sponsor: Biocruces Bizkaia Health Research Institute
Sponsor class: OTHER_GOV
Collaborators: name: University Ghent
name: FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA
name: Hellenic Mediterranean University
name: University of Zurich
name: FISABIO (Foundation for the Promotion of Healthcare and Biomedical Research in the Valencian Community)
name: Cyprus Association of Cancer Patients and Friends (PASYKAF)
name: Alma Mater Europaea University
name: The Oncology Institute "Prof. Dr. Ion Chiricuţă" Cluj-Napoca
First posted: 2025-04-10
Enrollment: 3500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicentre, multinational, 2-arm, parallel-group, hybrid effectiveness implementation cluster randomized control trial.
Primary purpose: PREVENTION

Brief 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.

Detailed description: Cancer is a leading cause of death worldwide, responsible for an estimated 9.9 million deaths in 2020. Many cancers can currently be prevented by avoiding risk factors, implementing evidence-based prevention strategies, and adopting healthy behaviours. Adolescence is a critical period for establishing these behaviours, as many risk behaviours such as smoking and poor diet begin at this stage. Despite numerous school-based interventions, significant gaps remain in achieving sustainable health behaviour changes among adolescents.

The SUNRISE project aims to bridge these gaps and reduce social inequalities in primary cancer prevention among adolescents in Europe. Traditional health promotion programs face barriers such as the need for extensive resources and continuous support for educators. Digital interventions offer a promising solution by providing cost-effective, engaging, and tailored content accessible 24/7. As part of its comprehensive approach, SUNRISE seeks to test various innovative solutions, including the SmartCoach program, to determine the most effective strategies for adolescent health promotion.

SmartCoach, developed by Swiss Research Institute for Public Health and Addiction (ISGF), is a mobile phone-based life-skills training program designed to prevent substance use among adolescents. It has shown significant long-term effectiveness in reducing tobacco smoking and cannabis use. Based on Social Cognitive Theory, SmartCoach promotes self-management skills, social skills, and substance use resistance through tailored weekly text messages over a period of several months.

Adolescence is a period of significant biological, psychological, and social transitions. These transitions provide opportunities for skill development but also present risks for developing harmful behaviours. Substance use often begins during adolescence, with increased prevalence of alcohol, tobacco, and cannabis consumption as teen's age. For instance, the Health Behaviour in School-aged Children (HBSC) study showed noticeable increases in the lifetime prevalence of these substances among 11-to-15-year-olds. Schools are ideal settings for delivering preventive interventions due to their accessibility to young people.

Life-skills training programs, which focus on self-management, social skills, and substance use resistance, have proven effective but face challenges in implementation and sustainability. Traditional face-to-face interventions require substantial resources and commitment from educators. Digital interventions, such as those delivered via mobile phones, can overcome these obstacles by providing flexible, engaging, and tailored content.

SmartCoach addresses key concepts of Social Cognitive Theory, such as outcome expectations, self-efficacy, observational learning, facilitation, and self-regulation. The program in its previous version provided:

* Automated Messaging: 2-4 messages per week focusing on self-management skills, social skills, and substance use resistance.
* Interactive Features: Quizzes to tailor behavioural plans, friendly competitions to incentivize engagement, and integration with social media platforms like YouTube.

A cluster-randomized controlled trial in Switzerland showed high acceptance and promising effectiveness of SmartCoach among secondary and upper secondary school students, with significant longer-term reductions in tobacco- and cannabis use prevalence. Active program engagement was stimulated by interactive features such as quiz questions, message and picture contests, and the integration of a friendly competition with prizes, where users collected credits with each interaction.

Popular online social media platforms (e.g., WhatsApp, YouTube, TikTok) play a significant role in young people's lives and offer powerful spaces to reach them and influence their health. These platforms provide interactive functionalities and have great potential for user engagement and retention. Health behaviour change interventions using social media have shown modest evidence of effectiveness, and there have been calls to strengthen research targeting adolescents and the sustainability of their behaviour changes in the longer term. An automated WhatsApp-based coaching program for smoking cessation developed by ISGF provides a foundation for further development within the SUNRISE project.

SmartCoach will be enhanced within the SUNRISE project by leveraging the interactive and engaging features of social media platforms. Adolescents spend a considerable amount of time on platforms like WhatsApp, YouTube, and TikTok, making these platforms ideal for delivering health interventions. By integrating SmartCoach with these social media platforms, the program aims to increase engagement, retention, and effectiveness.

For instance, WhatsApp can be used to send automated messages and provide a communication channel for adolescents to interact with addiction experts. YouTube and TikTok can be used to share engaging multimedia content that promotes healthy behaviours and provides educational resources about cancer prevention. These platforms can also facilitate peer support and create a community of adolescents who are committed to adopting healthier lifestyles.

By integrating digital tools and leveraging social media, SmartCoach aims to create a more engaging, effective, and sustainable intervention for adolescent health behaviour change. The focus is primarily on preventing substance use and promoting healthy lifestyles to reduce the risk of cancer. The SUNRISE project seeks to bridge existing gaps in adolescent health promotion, reduce social inequalities in primary cancer prevention, and become a reference point in Europe and beyond for adolescents, their parents, educators, and public health experts.

The SUNRISE project and the SmartCoach program represent a significant step forward in the primary prevention of cancer among adolescents. By addressing the challenges of traditional health promotion programs and leveraging the power of digital interventions, these initiatives aim to create lasting health behaviour changes that will reduce the risk of cancer and improve overall health outcomes for future generations.

Eligibility criteria: 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 outcomes:
measure: Point prevalence rate of tobacco or nicotine use
timeFrame: The primary outcomes will be assessed at baseline, 6 months, and 18 months follow-up
Secondary outcomes:
measure: Frequency of tobacco cigarette smoking
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: Prevalence and frequency of other nicotine products use
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: Prevalence and frequency of cannabis use
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: Prevalence and frequency of alcohol use
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: Perceived Stress
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: Social skills
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: Healthy eating habits
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
measure: EuroQoL-5D-5L questionnaire
timeFrame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University (UGENT)
city: Nicosia
country: Cyprus
facility: Cyprus Association of Cancer Patients and Friends (PASYKAF)
city: Heraklion
country: Greece
facility: Hellenic Mediterranean University (HMU)
city: Roma
country: Italy
facility: Italian Federation of Voluntary Associations in Oncology (FAVO)
city: Cluj-Napoca
country: Romania
facility: Institute of Oncology "Prof dr. Ion Chiricuta" CLUJ NAPOCA (IOCN)
city: Maribor
country: Slovenia
facility: Alma Mater Europaea University (AMEU)
city: Valencia
country: Spain
facility: Foundation for the Promotion of Health and Biomedical Research of the Valencian Community (Fisabio
city: Zürich
country: Switzerland
facility: Swiss Research Institute for Public Health and Addiction (ISGF)
Study officials:
References:
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