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SUNRISE Aims to Create a Comprehensive, Engaging, and Sustainable Digital Health Promotion Program That Not Only Addresses Immediate Health Behaviours But Also Instils Lifelong Healthy Habits Among Adolescents. It is a Unique, Digitally Enhanced Program Combining Different Digital Solutions With New

Observational Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SUNRISE program.
Who it may be relevant to
Registry conditions: Cancer. Basic parameters: 10 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Cyprus, Greece, Italy, Romania +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

SUstaiNable inteRventions and Healthy behavIours for adoleScent Primary prEvention of Cancer With Digital Tools. Study 2: Multiple Behaviour Intervention Platform

Overview

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 interventions on students across eight European countries, including Greece, Switzerland, Slovenia, Spain, Cyprus, Italy, Belgium, and Romania. This study focuses on integrating a unique, digitally enhanced program combining different digital solutions with new methods to change adolescent health behaviour through social media campaigns, social bot platforms, educational games, and health-related advertising content 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.

Detailed description

Cancer remains one of the leading causes of death globally, with significant potential for prevention through early adoption of healthy behaviours. Adolescence is a crucial period for establishing such behaviours, and digital interventions offer a promising avenue for promoting sustained health behaviour changes. The SUNRISE project is dedicated to enhancing primary cancer prevention among adolescents in Europe by leveraging innovative digital tools and methodologies.

The Study 2 of the SUNRISE project aims to test its interventions on 4,000 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 in 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.

Adolescence is a period of significant biological, psychological, and social transitions, presenting both opportunities for skill development and risks for harmful behaviours. Substance use often begins during this time, with increased prevalence of alcohol, tobacco, and cannabis consumption as teenagers' age. Furthermore, adolescents are highly susceptible to influences from their social environment, including peers and media. Social media platforms and influencers play a significant role in shaping their attitudes and behaviours, making it essential to leverage these tools to promote healthy behaviours and critical thinking. Schools are ideal settings for preventive interventions due to their accessibility to young people. Platforms like WhatsApp, YouTube, and TikTok offer powerful spaces to reach and engage adolescents, providing interactive functionalities that can impact their health positively. Health behaviour change interventions using social media have shown modest evidence of effectiveness, highlighting the need for further research to target adolescents and ensure the sustainability of behaviour changes in the long term.

SUNRISE sets itself apart from other studies by employing a comprehensive, multi-faceted approach that integrates various digital tools tailored to the specific needs of adolescents. Unlike traditional health promotion programs, which often face challenges in resource allocation and educator support, SUNRISE leverages digital platforms to provide cost-effective, engaging, and personalized interventions. This approach not only makes health information more accessible but also ensures continuous engagement through platforms that adolescents already use for leisure.

The intervention will include a variety of digital tools designed to promote cancer prevention behaviours. These tools will be tailored to the needs of each school through authoring and monitoring platforms, enabling educators to adapt the content and delivery methods. The primary digital solutions include:

* SmartCoach: This mobile-based life-skills training program is designed to prevent substance use by sending tailored messages focusing on self-management, social skills, and substance use resistance. These messages are delivered 2-4 times a week and are integrated with social media platforms to enhance engagement and reach. * Innovative Social Robots and Conversational Assistants: These tools interact with adolescents through voice commands, offering personalized responses and motivational support. They employ quizzes and persuasive multimedia content to assess and influence health behaviours in areas like diet, physical activity, and advertising literacy. * Educational and Serious Games: Interactive games designed to improve health knowledge and behaviour. These games are accessible via mobile devices and include scenarios that teach adolescents about the risks of unhealthy food advertising and other health-related topics. * Influencer Campaigns: Co-created with adolescents, nutrition experts, and influencers, these campaigns aim to combat nutritional misinformation on social media. Influencers will create and share content designed to improve adolescents' understanding and critical evaluation of health information online. * Health and Advertisement Educational Module: This module uses interactive content such as videos and quizzes to educate adolescents on healthy eating and the tactics used in advertising. It aims to enhance their ability to critically evaluate health messages and make informed decisions.

The implementation of these interventions will be closely monitored and evaluated to assess their effectiveness and sustainability. This will involve statistical analysis of individual outcomes, focus groups, semi-structured interviews with parents, educators, and students, and cost-effectiveness analysis to predict long-term health and economic impacts. The evaluation process is designed to capture a comprehensive picture of how the interventions influence behaviour, well-being, and overall health literacy among adolescents. In addition, PARTICLE.TALK social media platform can collect details of the participants' interaction and its evolution as the study evolves to better support the monitoring and evaluation phases of the study.

SUNRISE aims to create a comprehensive, engaging, and sustainable digital health promotion program that not only addresses immediate health behaviours but also instils 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.

Interventions

  • Other SUNRISE program
    The program will use several solutions, each focusing on different aspects of health promotion: * SmartCoach, a mobile phone-based life-skills training program, focuses on self-management, social skills, and substance use resistance. * Social robots and conversational assistants aim to engage students through interactive sessions on health topics like diet and physical activity. * Educational and serious games enhance knowledge and resistance to unhealthy food marketing, providing an engaging w

Primary outcome measures

  • Feasibility of the Digitally-Enhanced Program [Time frame: 18 months]
Secondary outcome measures (10)
  • 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]
  • Physical Activity [Time frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up]
  • Health Literacy [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]

Eligibility criteria

Inclusion criteria

  • Minimum Age: Students must be at least 10 years old at the time of enrolment.
  • Devices and Internet Access: Students must have access to an electronic device with Internet connectivity.
  • Informed Consent: Students must provide their signed informed consent to participate in the study.
  • Parental Consent: Students, when necessary, must obtain and submit signed informed consent from a parent or legal guardian.

Exclusion criteria

  • Age Restrictions: Students who are younger than 10 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Belgium · 1 center
  • Ghent University (UGENT) — Zürich
Cyprus · 1 center
  • Cyprus Association of Cancer Patients and Friends (PASYKAF) — Nicosia
Greece · 1 center
  • Hellenic Mediterranean University (HMU) — Heraklion
Italy · 1 center
  • Italian Federation of Voluntary Associations in Oncology (FAVO) — Roma
Romania · 1 center
  • Institute of Oncology "Prof dr. Ion Chiricuta" CLUJ NAPOCA (IOCN) — Cluj-Napoca
Slovenia · 1 center
  • Alma Mater Europaea University (AMEU) — Maribor
Spain · 1 center
  • Foundation for the Promotion of Health and Biomedical Research of the Valencian Community — Valencia
Switzerland · 1 center
  • Swiss Research Institute for Public Health and Addiction (ISGF) — Zurich

Publications

  • De Jans S, Spielvogel I, Naderer B, Hudders L. Digital food marketing to children: How an influencer's lifestyle can stimulate healthy food choices among children. Appetite. 2021 Jul 1;162:105182. doi: 10.1016/j.appet.2021.105182. Epub 2021 Mar 3. PMID 33667499
  • 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
  • Bailey JV, Murray E, Rait G, Mercer CH, Morris RW, Peacock R, Cassell J, Nazareth I. Interactive computer-based interventions for sexual health promotion. Cochrane Database Syst Rev. 2010 Sep 8;2010(9):CD006483. doi: 10.1002/14651858.CD006483.pub2. PMID 20824850
  • 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
  • O'Keeffe GS, Clarke-Pearson K; Council on Communications and Media. The impact of social media on children, adolescents, and families. Pediatrics. 2011 Apr;127(4):800-4. doi: 10.1542/peds.2011-0054. Epub 2011 Mar 28. PMID 21444588
  • Colditz GA, Wei EK. Preventability of cancer: the relative contributions of biologic and social and physical environmental determinants of cancer mortality. Annu Rev Public Health. 2012 Apr;33:137-56. doi: 10.1146/annurev-publhealth-031811-124627. Epub 2012 Jan 3. PMID 22224878
  • Barasoain M, Velez-Del-Burgo A, Astigarraga I, Haug S, Kiselev N, Koutra K, Kilintzis V, Krini M, Pampaka T, Hudders L, De Keyzer E, Serrano P, Pilotti C, Del Campo L, Nicoara D, Nicoara N, Molina-Barcelo A, de Pablo Pardo T, Verduyn S, Cea G, Katsapi C, Segal LJ, Tsoupouroglou I, Guerra B, Triantafyllidis A, Arana-Arri E; SUNRISE Study Group. Strengthening cancer prevention in european schools: a PMID 42351094

Identifiers

NCT: NCT06931847 · SUNRISE_Study2 · PI2024216

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗