Skin CancerShadow4AllNCT06145464
Shadow for All, a Citizenship Science Study to Promote the Prevention of Skin Cancer
A study testing Adhesion to the use of collective shadow, Adhesion to the use of sun protector and Adhesion to the use of the information disposed in the infographic in people with Skin Cancer, run by Universidade do Porto.
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… Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Adhesion to the use of collective shadow, Adhesion to the use of sun protector and Adhesion to the use of the information disposed in the infographic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- Students at a higher education course in the area of health sciences;
Show all 14Show fewer
- Age between 18 and 25 years old;
- Motivated to the field of health communication;
- Preferably, with experience in research work during the course.
- 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.
Who cannot join
- Cognitive, hearing, visual and/or motor limitations that prevent the acquisition of knowledge and the use of sun protection strategies on the beach
- Cognitive, hearing, visual and/or motor limitations that prevent the acquisition and transmission of knowledge
- Cognitive, hearing, visual and/or motor limitations that prevent the acquisition and transmission of knowledge
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Skin Cancer
- Being tested
- Adhesion to the use of collective shadow, Adhesion to the use of sun protector, Adhesion to the use of the information disposed in the infographic, Adhesion to the health literacy sessions in the interventional groups
- Keywords
- skin cancer, prevention, adolescents, literacy, citizen science
- Medical subject headings
- Skin Neoplasms, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhesion to the use of collective shadowBehavioural
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 protectorBehavioural
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 infographicBehavioural
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 groupsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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. Receives: 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 |
| Interventional EST SUP | Experimental | 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. Receives: 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 |
| Interventional FARMA | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months (July + August 2024)
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
Measured: 2 months (July + August 2024)
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
Measured: 2 months (July + August 2024)
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
Measured: 2 months (July + August 2024)
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
Measured: 2 months (July + August 2024)
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
Measured: 2 months (July + August 2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Feb 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory pilot study, with a quasi-experimental design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magda Fonseca, Master, Principal investigator, RD-Portugal (Rare Diseases-Portugal)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145464
- Sponsor's protocol ID
- Shadow4All
- Acronym
- Shadow4All
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shadow for All, a Citizenship Science Study to Promote the Prevention of Skin Cancer
- ClinicalTrials.gov ID
- NCT06145464
- Acronym / sponsor ID
- Shadow4All / Shadow4All
- Conditions
- Skin Cancer
- Keywords
- skin cancer, prevention, adolescents, literacy, citizen science
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Exploratory pilot study, with a quasi-experimental design
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | 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 infographicAdolescents 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. |
| Interventional EST SUP | Experimental | 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 groupsAdolescents 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. |
| Interventional FARMA | Experimental | 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 groupsAdolescents 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (3 listed)
- Cognitive, hearing, visual and/or motor limitations that prevent the acquisition of knowledge and the use of sun protection strategies on the beach
- Cognitive, hearing, visual and/or motor limitations that prevent the acquisition and transmission of knowledge
- Cognitive, hearing, visual and/or motor limitations that prevent the acquisition and transmission of knowledge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adhesion to the use of collective shadowQuantitative 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. | Behavioural | Control, Interventional EST SUP, Interventional FARMA |
| Adhesion to the use of sun protectorQuantitative evaluation of the use of sun protector according to the recommendations provided in all groups of the study. | Behavioural | Control, Interventional EST SUP, Interventional FARMA |
| Adhesion to the use of the information disposed in the infographicQuantitative evaluation of the use of the information disposed in the infographic and provided in all groups of the study. | Behavioural | Control, Interventional EST SUP, Interventional FARMA |
| Adhesion to the health literacy sessions in the interventional groupsProvision 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 | Behavioural | Interventional EST SUP, Interventional FARMA |
Primary outcome
Adhesion to the use of sunsail shadows
Time frame: 2 months (July + August 2024)
Number of adolescents who use the sunsail shadows among all participant adolescents, in all groups of the study
Adhesion to the use of sunscreen
Time frame: 2 months (July + August 2024)
Number of adolescents who adhere to the use of sunscreen among all participant adolescents, in all groups of the study
Adhesion to the use of infographic´s information
Time frame: 2 months (July + August 2024)
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
Adhesion to the use of interventional strategies of sun protection at the beach
Time frame: 2 months (July + August 2024)
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
Skin absorption of UV radiation
Time frame: 2 months (July + August 2024)
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
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
Time frame: 2 months (July + August 2024)
Amount of skin UV absorption per total number of participant adolescents in both interventional groups, in relation to the control group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magda Fonseca, Master principal investigator
RD-Portugal (Rare Diseases-Portugal)
Questions about this trial
What is this clinical trial studying?
A study testing Adhesion to the use of collective shadow, Adhesion to the use of sun protector and Adhesion to the use of the information disposed in the infographic in people with Skin Cancer, run by Universidade do Porto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magda Fonseca, Master (00351968027910, magdapcfonseca81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhesion to the use of sunsail shadows (time frame: 2 months (July + August 2024)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.