Shadow for All, a Citizenship Science Study to Promote the Prevention of Skin Cancer

Skin Cancer Clinical Trial

— Shadow4All  

Official title:

Shadow for All, a Citizenship Science Study to Promote the Prevention of Skin Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06145464
• Other study ID #: Shadow4All
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: Universidade do Porto
• Contact: Magda Fonseca, Master
• Phone: 00351968027910
• Email: magdapcfonseca81[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed project is a pilot study about the impact of different health literacy interventions, focused on preventing skin cancer, on the adhesion to protection strategies against ultraviolet (UV) radiation, observed in high school students, that will be implemented on Foz do Lizandro beach in the municipality of Mafra, Portugal. As a science project with citizenship and respecting the ethic principles of equity, inclusion and diversity, the study will involve the contribution and participation of institutional and community partners in diverse stages of the research study: design, field implementation, data collection and dissemination of results, as well as financial investment for the acquisition and installation of interventions on the beach, and recruitment of the target population.

Description:

The incidence of skin cancer has increased very fast globally, largely due to poor protective behavior against highly harmful UV solar radiation, particularly among the Caucasian population, who are the most affected by this type of cancer. Scientific literature suggests that adolescents between14 and 17 years old are very susceptible to getting sunburned at least once, which doubles the risk of developing skin cancer in adulthood. It is also known that literacy about skin cancer and its prevention is not high in these younger age groups. These data suggest that the design of public health policies aimed at adolescents, focused on promoting healthy habits of exposure to solar and artificial UV radiation, should be a priority. Based on this scientific evidence, a quasi-experimental and interventional pilot study is proposed, through which the aim is to motivate adolescents between 14 and 17 years old to adhere to the use of sun protection strategies to be implemented on Foz do Lizandro beach in municipality of Mafra, Portugal.The research question is to understand whether different literacy sessions on skin cancer prevention have a different impact on adhesion to sun protection strategies used by participating adolescents. Considering the enormous potential of the study to become a science project with citizenship, its design was adapted to this increasingly valued modality of research, so that local community entities and national institutions are part of the study as individual and collective partners, participating in the various stages of the investigation, from structuring, implementation in the field, analysis and dissemination of results. Values such as equity, inclusion, diversity and sustainability are inherent to the study. Monitoring of project implementation will be done through the determination of rigorously planned quality indicators. It is expected that this study will have a positive impact on Mafra community and will be replicated in other geographic regions, leading to significantly higher literacy levels on skin cancer prevention among the youngest citizens.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria for adolescents

• High school students at a public school in Mafra;
• Age between 14 and 17 years old;
• Residents in Mafra;
• Fluent in the Portuguese language;
• Regular users of beaches in the summer season Exclusion Criteria for adolescents
• Cognitive, hearing, visual and/or motor limitations that prevent the acquisition of knowledge and the use of sun protection strategies on the beach Inclusion Criteria for universitarian students
• Students at a higher education course in the area of health sciences;
• Age between 18 and 25 years old;
• Motivated to the field of health communication;
• Preferably, with experience in research work during the course. Exclusion Criteria for universitarian students
• Cognitive, hearing, visual and/or motor limitations that prevent the acquisition and transmission of knowledge Inclusion Criteria for community pharmacists
• Professionally active in a community pharmacy in the region where the beach is located;
• Preferably young people between 23 and 45 years old, regardless of professional experience;
• With motivation for awareness-raising activities on disease prevention in communities;
• Preferably, who have already carried out this type of awareness-raising actions among younger people on disease prevention or, specifically, on the prevention of skin cancer;
• Affinity for the topic of skin cancer and its prevention. Exclusion Criteria for community pharmacists
• Cognitive, hearing, visual and/or motor limitations that prevent the acquisition and transmission of knowledge

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Intervention

Behavioral:
• Adhesion to the use of collective shadow
Quantitative evaluation of the use of shadow provided by one or two collective fabric devices, with 6 per 3 metres of size, containing 100% UV blocking filters, that will be installed in the sand on Foz do Lizandro beach, according to the recommendations provided in all groups of the study.
• Adhesion to the use of sun protector
Quantitative evaluation of the use of sun protector according to the recommendations provided in all groups of the study.
• Adhesion to the use of the information disposed in the infographic
Quantitative evaluation of the use of the information disposed in the infographic and provided in all groups of the study.
• Adhesion to the health literacy sessions in the interventional groups
Provision of health literacy sessions about skin cancer prevention by two different types of providers in the two interventional groups, 15 days before the use of sun protective interventions implemented at the beach

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Porto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adhesion to the use of sunsail shadows	Number of adolescents who use the sunsail shadows among all participant adolescents, in all groups of the study	2 months (July + August 2024)
Primary	Adhesion to the use of sunscreen	Number of adolescents who adhere to the use of sunscreen among all participant adolescents, in all groups of the study	2 months (July + August 2024)
Primary	Adhesion to the use of infographic´s information	Number of adolescents who read and use the information related to the promotion of healthy sun exposure behaviors, from the infographic located near the sunsail shadows, in all groups of the study	2 months (July + August 2024)
Primary	Adhesion to the use of interventional strategies of sun protection at the beach	Number of adolescents who use one, two or all of the three interventional strategies of sun protection implemented at the beach, in all groups of the study	2 months (July + August 2024)
Primary	Skin absorption of UV radiation	Number of adolescents who have a safe skin UV radiation absorption according to the interventional sun protection strategies used, in all groups of the study	2 months (July + August 2024)
Primary	Impact of literacy sessions about the prevention of skin cancer on the amount of skin UV absorption in all interventional groups compared to the control group	Amount of skin UV absorption per total number of participant adolescents in both interventional groups, in relation to the control group	2 months (July + August 2024)