An interventional study of SmartCoach in Cancer, sponsored by Biocruces Bizkaia Health Research Institute. Not yet recruiting at 8 sites in 8 countries. Open to participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by Biocruces Bizkaia Health Research Institute · Not applicable, Interventional, and Prevention
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.
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:
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 3,500 is above the median of 60 across 7,703 interventional 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.
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
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).
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.
Time frame: The primary outcomes will be assessed at baseline, 6 months, and 18 months follow-up
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
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 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 18 months is below that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
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