An observational study in Cancer, sponsored by Biocruces Bizkaia Health Research Institute. Not yet recruiting at 8 sites in 8 countries. Open to participants aged 10 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by Biocruces Bizkaia Health Research Institute · Observational
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.
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:
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Biocruces Bizkaia Health Research Institute is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Secondary and upper secondary students between 10 and 19 years old (at time of recruitment), who are freely willing to participate in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention
SUNRISE program
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 way to learn about advertising tactics and healthy eating. * The influencer campaign tackles nutritional misinformation by using content created by influencers to educate adolescents on detecting and critically evaluating misleading health information. * Health and advertisement educational module aims to educate students on recognizing deceptive advertising and making informed choices about their health.
Feasibility of the Digitally-Enhanced Program
This will be measured by evaluating the usage and engagement with the intervention, through a in-house authoring and monitoring tool. This tool will include the questionnaires, statistical displays, interactive visualization of data and reporting tools for monitoring and assessment of the intervention outcomes.
Time frame: 18 months
Frequency of tobacco cigarette smoking
Determined by the number of days on which tobacco cigarettes were smoked in the last 30 days
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
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Physical Activity
Determined by 2 questions: * Over the past 7 days, on how many days were you physically active for a total of at least 60 minutes per day? (0 days - 7 days) * Outside school hours: how often do you usually exercise in your free time so much that you get out of breath or sweat? (Every day; 4 to 6 times a week; 2 to 3 times a week; Once a month; Less than once a month; Never)
Time frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Health Literacy
Assessed utilizing the HLS-EU-Q16 Scale that measures health literacy in three domains: health care (seven items), disease prevention (five items) and health promotion (four items). Each question of HLS-EU-Q16 was answered by choosing one response of the available choices: 'very difficult', 'fairly difficult', 'fairly easy' and 'very easy'. Each of the 16 questions were coded according to the following: 'very difficult' = 1 point, 'fairly difficult' = 2 points, 'fairly easy' = 3 points or 'very easy' = 4 points, giving a total of 16-64 scores. The HLS-EU-Q16 manual recommends dichotomising the answers from HLS-EU-Q16 ('very difficult'/'fairly difficult' = 0, 'fairly easy'/'very easy' = 1; total 0-16 scores) and dividing the total scores into three categories ('likely inadequate HL '(0-8 scores), 'likely problematic HL' (9-12 scores) and 'likely sufficient HL' (13-16 scores).
Time frame: 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
Time frame: The secondary outcomes will also be assessed at baseline, 6 months, and 18 months follow-up
Plan to share: No
Start is estimated for Sep 2025; primary completion for Mar 2027, 18 months later.
Of 1,098 non-industry observational studies under Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 227. This study's planned 18 months is below that.
Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Biocruces Bizkaia Health Research Institute