CancerSUNRISE_1NCT06922201
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
A study testing SmartCoach in people with Cancer, run by Biobizkaia Health Research Institute at 8 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- SmartCoach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Sep 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
8 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 8 countries
Belgium1 site
Ghent University (UGENT)
Ghent, 9000
Liselot Hudders, PhD, +32 9 264 68 90, Liselot.Hudders@UGent.be
Hayley Pearce, Hayley.Pearce@UGent.be
Cyprus1 site
Cyprus Association of Cancer Patients and Friends (PASYKAF)
Nicosia, 1687
Theophano Pampaka, +357 22 050813, theophano@pasykaf.org
Maria Krini, mariakr@pasykaf.org
Greece1 site
Hellenic Mediterranean University (HMU)
Heraklion, 71410
Kleio Koutra, PhD, +302810379243, kkoutra@hmu.gr
Vassilis Kilintzis, billyk@ics.forth.gr
Italy1 site
Italian Federation of Voluntary Associations in Oncology (FAVO)
Roma, 00187
Chiara Pilotti, +348 0515863, cpilotti@favo.it
Laura Del Campo, ldelcampo@favo.it
Romania1 site
Institute of Oncology "Prof dr. Ion Chiricuta" CLUJ NAPOCA (IOCN)
Cluj-Napoca, 4547125
Delia Nicoara, Dr., +40 264 598 362, delianicoara13@gmail.com
Nina Nicoara, nina.nicoara@outlook.com
Slovenia1 site
Alma Mater Europaea University (AMEU)
Maribor, 2000
Polonca Serrano, PhD, +386 41 959 895, polonca.pangrcic@almamater.si
David Bogataj
Spain1 site
Foundation for the Promotion of Health and Biomedical Research of the Valencian Community (Fisabio
Valencia, 46010
Ana Molina-Barceló, PhD, +34 961 925 700, ana.molina@fisabio.es
Teresa de Pablo-Pardo, +34 961 972 560, teresa.depablo@fisabio.es
Switzerland1 site
Swiss Research Institute for Public Health and Addiction (ISGF)
Zurich, 8005
Severin Haug, PhD, +41 44 448 11 74, severin.haug@isgf.uzh.ch
Nikolai Kiselev, PhD, nikolai.kiselev@isgf.uzh.ch
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- SmartCoach
- Keywords
- SUNRISE, SmartCoach, Life-skills training, substance use prevention, adolescents
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartCoachOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| Intervention | Experimental | SmartCoach program Receives: Other: SmartCoach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The primary outcomes will be assessed at baseline, 6 months, and 18 months follow-up
Secondary outcomes (8)
Frequency of tobacco cigarette smoking
Determined by the number of days on which tobacco cigarettes were smoked in the last 30 days
Measured: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
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
Measured: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Prevalence and frequency of cannabis use
Measured by the number of cannabis (containing THC) consumption days in the preceding 30 days
Measured: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Prevalence and frequency of alcohol use
Assessed by the number of alcohol use days in the preceding 30 days
Measured: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Perceived Stress
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.
Measured: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Social skills
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.
Measured: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Healthy eating habits
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).
Measured: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
EuroQoL-5D-5L questionnaire
Scoring from 0-100 points. 0 points low quality of life 100 high quality of life
Measured: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicentre, multinational, 2-arm, parallel-group, hybrid effectiveness implementation cluster randomized control trial.
- Masking
- None (open label)
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biobizkaia Health Research Institute
- Sponsor type
- Other government
- Collaborators
- University Ghent, FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA, Hellenic Mediterranean University, University of Zurich, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana, Cyprus Association of Cancer Patients and Friends (PASYKAF), Alma Mater Europaea - Slovenia, The Oncology Institute "Prof. Dr. Ion Chiricuţă" Cluj-Napoca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922201
- Sponsor's protocol ID
- SUNRISE_Study1
- Acronym
- SUNRISE_1
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maher CA, Lewis LK, Ferrar K, Marshall S, De Bourdeaudhuij I, Vandelanotte C. Are health behavior change interventions that use online social networks effective? A systematic review. J Med Internet Res. 2014 Feb 14;16(2):e40. doi: 10.2196/jmir.2952.
PubMed 24550083Bandura A. Health promotion by social cognitive means. Health Educ Behav. 2004 Apr;31(2):143-64. doi: 10.1177/1090198104263660.
PubMed 15090118Haug S, Schaub MP, Venzin V, Meyer C, John U. Efficacy of a text message-based smoking cessation intervention for young people: a cluster randomized controlled trial. J Med Internet Res. 2013 Aug 16;15(8):e171. doi: 10.2196/jmir.2636.
PubMed 23956024Stockings E, Hall WD, Lynskey M, Morley KI, Reavley N, Strang J, Patton G, Degenhardt L. Prevention, early intervention, harm reduction, and treatment of substance use in young people. Lancet Psychiatry. 2016 Mar;3(3):280-96. doi: 10.1016/S2215-0366(16)00002-X. Epub 2016 Feb 18.
PubMed 26905481Thomas RE, McLellan J, Perera R. School-based programmes for preventing smoking. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD001293. doi: 10.1002/14651858.CD001293.pub3.
PubMed 23633306Haug S, Paz Castro R, Wenger A, Schaub MP. A Mobile Phone-Based Life-Skills Training Program for Substance Use Prevention Among Adolescents: Cluster-Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Jul 13;9(7):e26951. doi: 10.2196/26951.
PubMed 34255703Champion KE, Parmenter B, McGowan C, Spring B, Wafford QE, Gardner LA, Thornton L, McBride N, Barrett EL, Teesson M, Newton NC; Health4Life team. Effectiveness of school-based eHealth interventions to prevent multiple lifestyle risk behaviours among adolescents: a systematic review and meta-analysis. Lancet Digit Health. 2019 Sep;1(5):e206-e221. doi: 10.1016/S2589-7500(19)30088-3. Epub 2019 Aug 19.
PubMed 33323269Paz Castro R, Haug S, Wenger A, Schaub MP. Longer-Term Efficacy of a Digital Life-Skills Training for Substance Use Prevention. Am J Prev Med. 2022 Dec;63(6):944-953. doi: 10.1016/j.amepre.2022.06.017. Epub 2022 Aug 18.
PubMed 35985899Domitrovich CE, Durlak JA, Staley KC, Weissberg RP. Social-Emotional Competence: An Essential Factor for Promoting Positive Adjustment and Reducing Risk in School Children. Child Dev. 2017 Mar;88(2):408-416. doi: 10.1111/cdev.12739. Epub 2017 Feb 18.
PubMed 28213889Al-Hosni K, Chan MF, Al-Azri M. The Effectiveness of Interventional Cancer Education Programs for School Students Aged 8-19 Years: a Systematic Review. J Cancer Educ. 2021 Apr;36(2):229-239. doi: 10.1007/s13187-020-01868-1.
PubMed 32895878Herlitz L, MacIntyre H, Osborn T, Bonell C. The sustainability of public health interventions in schools: a systematic review. Implement Sci. 2020 Jan 6;15(1):4. doi: 10.1186/s13012-019-0961-8.
PubMed 31906983Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Haug S, Wenger A, Arana-Arri E, Barasoain M, Velez-Del-Burgo A, Koutra K, Molina-Barcelo A, De Pablo-Pardo T, Kiselev N, Boumparis N, Studhalter O, Schaub MP, Hudders L, De Keyzer E, Folkvord F, Champion K, Triantafyllidis A; SUNRISE consortium. Efficacy of an instant messaging-based life-skills training program to prevent behavioral risk factors among adolescents in Europe: study protocol of a cluster-randomized controlled trial. BMC Psychol. 2025 Nov 24;13(1):1292. doi: 10.1186/s40359-025-03592-1.
PubMed 41286988
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUstaiNable inteRventions and Healthy behavIours for adoleScent Primary prEvention of Cancer With Digital Tools. Study 1: SmartCoach
- ClinicalTrials.gov ID
- NCT06922201
- Acronym / sponsor ID
- SUNRISE_1 / SUNRISE_Study1
- Conditions
- Cancer
- Keywords
- SUNRISE, SmartCoach, Life-skills training, substance use prevention, adolescents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Biobizkaia Health Research InstituteOther government
- Collaborators
- University Ghent, FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA, Hellenic Mediterranean University, University of Zurich, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana, Cyprus Association of Cancer Patients and Friends (PASYKAF), Alma Mater Europaea - Slovenia, The Oncology Institute "Prof. Dr. Ion Chiricuţă" Cluj-Napoca
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicentre, multinational, 2-arm, parallel-group, hybrid effectiveness implementation cluster randomized control trial.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Intervention | Experimental | Other: SmartCoachSmartCoach program |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartCoachParticipants 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). | Other | Intervention |
Primary outcome
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.
8 secondary outcomes
Frequency of tobacco cigarette smoking
Time frame: 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
Prevalence and frequency of cannabis use
Time frame: 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
Perceived Stress
Time frame: 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
Healthy eating habits
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Background: PubMed 24550083Maher CA, Lewis LK, Ferrar K, Marshall S, De Bourdeaudhuij I, Vandelanotte C. Are health behavior change interventions that use online social networks effective? A systematic review. J Med Internet Res. 2014 Feb 14;16(2):e40. doi: 10.2196/jmir.2952.
- Background: PubMed 15090118Bandura A. Health promotion by social cognitive means. Health Educ Behav. 2004 Apr;31(2):143-64. doi: 10.1177/1090198104263660.
- Background: PubMed 23956024Haug S, Schaub MP, Venzin V, Meyer C, John U. Efficacy of a text message-based smoking cessation intervention for young people: a cluster randomized controlled trial. J Med Internet Res. 2013 Aug 16;15(8):e171. doi: 10.2196/jmir.2636.
- Background: PubMed 26905481Stockings E, Hall WD, Lynskey M, Morley KI, Reavley N, Strang J, Patton G, Degenhardt L. Prevention, early intervention, harm reduction, and treatment of substance use in young people. Lancet Psychiatry. 2016 Mar;3(3):280-96. doi: 10.1016/S2215-0366(16)00002-X. Epub 2016 Feb 18.
- Background: PubMed 23633306Thomas RE, McLellan J, Perera R. School-based programmes for preventing smoking. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD001293. doi: 10.1002/14651858.CD001293.pub3.
- Background: PubMed 34255703Haug S, Paz Castro R, Wenger A, Schaub MP. A Mobile Phone-Based Life-Skills Training Program for Substance Use Prevention Among Adolescents: Cluster-Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Jul 13;9(7):e26951. doi: 10.2196/26951.
- Background: PubMed 33323269Champion KE, Parmenter B, McGowan C, Spring B, Wafford QE, Gardner LA, Thornton L, McBride N, Barrett EL, Teesson M, Newton NC; Health4Life team. Effectiveness of school-based eHealth interventions to prevent multiple lifestyle risk behaviours among adolescents: a systematic review and meta-analysis. Lancet Digit Health. 2019 Sep;1(5):e206-e221. doi: 10.1016/S2589-7500(19)30088-3. Epub 2019 Aug 19.
- Background: PubMed 35985899Paz Castro R, Haug S, Wenger A, Schaub MP. Longer-Term Efficacy of a Digital Life-Skills Training for Substance Use Prevention. Am J Prev Med. 2022 Dec;63(6):944-953. doi: 10.1016/j.amepre.2022.06.017. Epub 2022 Aug 18.
- Background: PubMed 28213889Domitrovich CE, Durlak JA, Staley KC, Weissberg RP. Social-Emotional Competence: An Essential Factor for Promoting Positive Adjustment and Reducing Risk in School Children. Child Dev. 2017 Mar;88(2):408-416. doi: 10.1111/cdev.12739. Epub 2017 Feb 18.
- Background: PubMed 32895878Al-Hosni K, Chan MF, Al-Azri M. The Effectiveness of Interventional Cancer Education Programs for School Students Aged 8-19 Years: a Systematic Review. J Cancer Educ. 2021 Apr;36(2):229-239. doi: 10.1007/s13187-020-01868-1.
- Background: PubMed 31906983Herlitz L, MacIntyre H, Osborn T, Bonell C. The sustainability of public health interventions in schools: a systematic review. Implement Sci. 2020 Jan 6;15(1):4. doi: 10.1186/s13012-019-0961-8.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- HBSC- Health Behaviour School-aged CildrenLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartCoach in people with Cancer, run by Biobizkaia Health Research Institute at 8 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, Cyprus, Greece, Italy, Romania and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eunate Arana-Arri, PhD (+34 944881593 ext. 841593, eunate.aranaarri@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06922201, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.