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 (SUNRISE_1)

April 9, 2025 updated by: Biocruces Bizkaia Health Research Institute

SUstaiNable inteRventions and Healthy behavIours for adoleScent Primary prEvention of Cancer With Digital Tools. Study 1: SmartCoach

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

3500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University (UGENT)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Liselot Hudders, PhD
        • Sub-Investigator:
          • Hayle Pearce
        • Sub-Investigator:
          • Dieneke Van de Sompel
  • Cyprus
      • Nicosia, Cyprus, 1687
        • Cyprus Association of Cancer Patients and Friends (PASYKAF)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Krini, PhD
        • Sub-Investigator:
          • Teophano Pampaka
  • Greece
      • Heraklion, Greece, 71410
        • Hellenic Mediterranean University (HMU)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kleio Koutra, PhD
        • Sub-Investigator:
          • Vassilis Kilintzis
  • Italy
      • Roma, Italy, 00187
        • Italian Federation of Voluntary Associations in Oncology (FAVO)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laura Del Campo
        • Sub-Investigator:
          • Chiara Pilotti
        • Sub-Investigator:
          • Rosalia Lombardi
  • Romania
      • Cluj-Napoca, Romania, 4547125
        • Institute of Oncology "Prof dr. Ion Chiricuta" CLUJ NAPOCA (IOCN)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Delia Nicoara, Dr.
        • Sub-Investigator:
          • Nina Nicoara
  • Slovenia
      • Maribor, Slovenia, 2000
        • Alma Mater Europaea University (AMEU)
        • Contact:
        • Contact:
          • David Bogataj
        • Sub-Investigator:
          • Polonca Serrano, PhD
        • Principal Investigator:
          • David Bogataj
  • Spain
      • Valencia, Spain, 46010
        • Foundation for the Promotion of Health and Biomedical Research of the Valencian Community (Fisabio
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Molina-Barceló, PhD
        • Sub-Investigator:
          • Teresa De Pablo-Pardo
        • Sub-Investigator:
          • Mireia Gandía
  • Switzerland
      • Zürich, Switzerland, 8005
        • Swiss Research Institute for Public Health and Addiction (ISGF)
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Niko Boumparis
        • Sub-Investigator:
          • Andreas Wenger, M.Sc.
        • Sub-Investigator:
          • Jeannine Jaggi
        • Principal Investigator:
          • Severin Haug, PhD
        • Sub-Investigator:
          • Nikolai Kiselev, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: Intervention
SmartCoach program
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Point prevalence rate of tobacco or nicotine use
Time Frame: The primary outcomes will be assessed at baseline, 6 months, and 18 months follow-up
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.
The primary outcomes will be assessed at baseline, 6 months, and 18 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of tobacco cigarette smoking
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Determined by the number of days on which tobacco cigarettes were smoked in the last 30 days
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Prevalence and frequency of other nicotine products use
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
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
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Prevalence and frequency of cannabis use
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Measured by the number of cannabis (containing THC) consumption days in the preceding 30 days
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Prevalence and frequency of alcohol use
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Assessed by the number of alcohol use days in the preceding 30 days
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Perceived Stress
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up

Measured using the 4-item version of the Perceived Stress Scale (PSS-4): The questions in this scale ask about the feelings and thoughts during the last month. In each case, the response represents how often participant felt or thought a certain way.

Scoring Instructions:

Total score is determined by adding together the scores of each of the four items. Questions 2 and 3 are reverse coded.

Questions 1 and 4: 0 = Never; 1 = Almost never; 2 = Sometimes; 3 = Fairly often; 4 = Very often Questions 2 and 3: 4 = Never; 3 = Almost never; 2 = Sometimes; 1 = Fairly often; 0 = Very often Lowest score: 0; Highest score: 16. Higher scores are correlated to more stress.
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Social skills
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up

Assessed utilizing the brief version of the Interpersonal Competence Questionnaire-10 (ICQ-10), which encompasses the following 5 domains: (1) initiation of relationships, (2) negative assertions, (3) disclosure of personal information, (4) emotional support, and (5) conflict management.

Scoring instructions: Good=4; Fairly good= 3; Rather poor=2; Poor=1. Total score is determined by adding the value of all items and dividing by 2. Maximum value= 20; Minimum value= 5. The higher the score, the higher the interpersonal competence.
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Healthy eating habits
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Measured using the WHO/HBSC eating habits questionnaire. Label values: 1 = never, 2 = Less than once a week, 3 = Once a week, 4 = 2-4 days a week, 5 = 5-6 days a week, 6 = Once a day (Every day), 7 = Every Day (more than once).
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
EuroQoL-5D-5L questionnaire
Time Frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Scoring from 0-100 points. 0 points low quality of life 100 high quality of life
The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocruces Bizkaia Health Research Institute

Collaborators

University of Zurich
University Ghent
FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA
Hellenic Mediterranean University
FISABIO (Foundation for the Promotion of Healthcare and Biomedical Research in the Valencian Community)
Cyprus Association of Cancer Patients and Friends (PASYKAF)
Alma Mater Europaea University
The Oncology Institute "Prof. Dr. Ion Chiricuţă" Cluj-Napoca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SUNRISE_Study1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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