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 | Not Yet Recruiting

• 1 other identifier: SUNRISE_Study1
• Study Type: interventional
• Target: 3,500
• Locations: 8 countries
• Sites: 8

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.

Conditions

Cancer

Keywords

SUNRISE; SmartCoach; Life-skills training; substance use prevention; adolescents

Outcome Measures

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.

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

Secondary Outcomes (8)

• Frequency of tobacco cigarette smoking

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

• Prevalence and frequency of other nicotine products use

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

• Prevalence and frequency of cannabis use

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

• Prevalence and frequency of alcohol use

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

• Perceived Stress

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

Study Arms (2)

Control

NO INTERVENTION

No intervention

Intervention

EXPERIMENTAL

SmartCoach program

Other: SmartCoach

Interventions

SmartCoach OTHER

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).

Intervention

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biobizkaia Health Research Institute: lead
• 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

Study Sites (8)

Ghent University (UGENT)

Ghent, 9000, Belgium

Location

Cyprus Association of Cancer Patients and Friends (PASYKAF)

Nicosia, 1687, Cyprus

Location

Hellenic Mediterranean University (HMU)

Heraklion, 71410, Greece

Location

Italian Federation of Voluntary Associations in Oncology (FAVO)

Roma, 00187, Italy

Location

Institute of Oncology "Prof dr. Ion Chiricuta" CLUJ NAPOCA (IOCN)

Cluj-Napoca, 4547125, Romania

Location

Alma Mater Europaea University (AMEU)

Maribor, 2000, Slovenia

Location

Foundation for the Promotion of Health and Biomedical Research of the Valencian Community (Fisabio

Valencia, 46010, Spain

Location

Swiss Research Institute for Public Health and Addiction (ISGF)

Zurich, 8005, Switzerland

Location

Related Publications (12)

• 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.

  PMID: 24550083 BACKGROUND

• Bandura A. Health promotion by social cognitive means. Health Educ Behav. 2004 Apr;31(2):143-64. doi: 10.1177/1090198104263660.

  PMID: 15090118 BACKGROUND

• Haug 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.

  PMID: 23956024 BACKGROUND

• Stockings 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.

  PMID: 26905481 BACKGROUND

• Thomas 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.

  PMID: 23633306 BACKGROUND

• Haug 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.

  PMID: 34255703 BACKGROUND

• Champion 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.

  PMID: 33323269 BACKGROUND

• Paz 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.

  PMID: 35985899 BACKGROUND

• Domitrovich 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.

  PMID: 28213889 BACKGROUND

• Al-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.

  PMID: 32895878 BACKGROUND

• Herlitz 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.

  PMID: 31906983 BACKGROUND

• Sung 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.

  PMID: 33538338 BACKGROUND

Related Links

• HBSC- Health Behaviour School-aged Cildren

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Eunate Arana-Arri, PhD

CONTACT

+34 944881593; eunate.aranaarri@osakidetza.eus

Maitane Barasoain, PhD

CONTACT

+34 946006239; maitane.barasoainhernandez@bio-bizkaia.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective, multicentre, multinational, 2-arm, parallel-group, hybrid effectiveness implementation cluster randomized control trial.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: April 10, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); IT (1); SL (1); CY (1); RO (1); ES (1); GR (1); BE (1)