Shadow4All: Shadow for All, a Citizenship Science Study to Promote the Prevention of Skin Cancer

Sponsor
Universidade do Porto (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06145464
Collaborator
(none)
60
3
8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Adhesion to the use of collective shadow
  • Behavioral: Adhesion to the use of sun protector
  • Behavioral: Adhesion to the use of the information disposed in the infographic
  • Behavioral: Adhesion to the health literacy sessions in the interventional groups
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Exploratory pilot study, with a quasi-experimental designExploratory pilot study, with a quasi-experimental design
Masking:
Single (Participant)
Masking Description:
The target population will be single-blinded towards the professional activity of providers of health literacy sessions about the prevention of skin cancer in the two interventional groups.
Primary Purpose:
Prevention
Official Title:
Shadow for All, a Citizenship Science Study to Promote the Prevention of Skin Cancer
Anticipated Study Start Date :
Feb 1, 2024
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control

Adolescents will be recommended to use the sun protection interventions implemented on Foz do Lizandro beach (collective shadow, sun protector, and information about healthy behaviors of sun protection disposed in an infographic installed near the collective shadow), without a previous health literacy session about skin cancer prevention provided 15 days before the beginning of the use of the interventions on the beach.

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.

Behavioral: 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.

Behavioral: 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.

Experimental: Interventional EST SUP

Adolescents will be recommended to use the sun protection interventions implemented on Foz do Lizandro beach (collective shadow, sun protector, and information about healthy behaviors of sun protection disposed in an infographic installed near the collective shadow), with a previous health literacy session about skin cancer prevention provided 15 days before the beginning of the use of the interventions on the beach by students on ongoing graduation at the University of Lisbon.

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.

Behavioral: 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.

Behavioral: 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.

Behavioral: 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

Experimental: Interventional FARMA

Adolescents will be recommended to use the sun protection interventions implemented on Foz do Lizandro beach (collective shadow, sun protector, and information about healthy behaviors of sun protection disposed in an infographic installed near the collective shadow), with a previous health literacy session about skin cancer prevention provided 15 days before the beginning of the use of the interventions on the beach by community pharmacists who will be working on pharmacies located in Mafra.

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.

Behavioral: 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.

Behavioral: 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.

Behavioral: 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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the adhesion of participating adolescents to the intervention strategies implemented in the three study groups [3 months]

    Use of indicators of adhesion to assess this outcome and collected through a questionnaire co-designed by the research team and participant citizens

  2. Evaluation of the impact of observed adhesion on the amount of UV radiation absorbed by the skin of adolescents participating in the three study groups [3 months]

    Use of indicators of adhesion to assess this outcome and collected through a questionnaire co-designed by the research team and participant citizens, as well as through the use of UV radiation absorption measuring bracelets

  3. Evaluation of the impact attributed to health literacy sessions carried out on the total amount of UV radiation absorbed in the interventional groups, compared to the control group [3 months]

    Use of indicators of adhesion to assess this outcome and collected through a questionnaire co-designed by the research team and participant citizens, as well as through the use of UV radiation absorption measuring bracelets

  4. Evaluation of the influence exerted by the type of provider of health literacy sessions in interventional groups on the total amount of UV radiation absorbed in these groups and in comparison to the control group [3 months]

    Use of indicators of adhesion to assess this outcome and collected through a questionnaire co-designed by the research team and participant citizens, as well as through the use of UV radiation absorption measuring bracelets

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Inclusion Criteria for adolescents

    1. high school students at a public school in Mafra; ii) age between 14 and 17 years old; iii) residents in Mafra; iv) natives of Portugal and fluent in the Portuguese language; and v) regular users of beaches in the summer.

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 universitary students

    1. students at a higher education course in the area of health sciences; ii) age between 18 and 25 years old; iii) motivated to the field of health communication; and iv) preferably, with experience in research work during the course.

Exclusion Criteria for universitary students

  • cognitive, hearing, visual and/or motor limitations that prevent the acquisition and transmission of knowledge

Inclusion Criteria for community pharmacists - i) professionally active in a community pharmacy in the region where the beach is located; ii) preferably young people between 23 and 45 years old, regardless of professional experience; iii) with motivation for awareness-raising activities on disease prevention in communities; iv) 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; and v) 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universidade do Porto

Investigators

  • Principal Investigator: Magda Fonseca, Master, RD-Portugal (Rare Diseases-Portugal)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universidade do Porto
ClinicalTrials.gov Identifier:
NCT06145464
Other Study ID Numbers:
  • Shadow4All
First Posted:
Nov 24, 2023
Last Update Posted:
Nov 24, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universidade do Porto
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2023