MelanomaPRESOLRENCT05367180
The Impact of a Prevention Program on Sun Risks in Primary School in Tropical French Region
A study testing MISOLRE prevention program on sun risks, "Vivre avec le Soleil" prevention program on sun risks and Sun protection equipment in people with Melanoma, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial summary
Sun exposure during childhood can cause the development of skin cancer in later years, in particular melanoma, which is the most lethal.The worldwide incidence of melanoma is on the rise, with nearly 290,000 new cases diagnosed in 2018. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- MISOLRE prevention program on sun risks, "Vivre avec le Soleil" prevention program on sun risks and Sun protection equipment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,452 participants
- Where
- 1 siteReunion
- Study dates
- 31 Aug 2022to 31 Dec 2023
- 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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- students in a primary school in Reunion Island, drawn by lot for the study and whose school director agrees to participate in the program
- in a primary school with more than 10 classes
- within a class from the second and the third cycle: CE (elementary course) 1, CE2, CM (average course) 1 or CM2
- whose 2 parents have given their consent
Who cannot join
- in a school that has already benefited from the awareness program by the MiSolRé association in 2016/2017, 2017/2018, 2019/2020, 2020/2021
- in CP (preparatory course) class
- in a multi-level class
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Prevention Program on Sun Risks in Primary School in Tropical French Region
Sun exposure during childhood can cause the development of skin cancer in later years, in particular melanoma, which is the most lethal.The worldwide incidence of melanoma is on the rise, with nearly 290,000 new cases diagnosed in 2018. The country with the highest age-standardized incidence rate is Australia, where 40.4 cases per 100,000 men and 27.5 cases per 100,000 women were reported in 2018. Since 2008, however, this incidence has decreased by 11% in the 14-49 age group following the implementation of effective sun safety campaigns. In the French overseas department of Reunion Island, which is characterized by a great diversity of skin phototypes due to multiple migratory flows, the ultraviolet (UV) index is very high - equivalent to that in Australia. The age-standardized incidence rate of melanoma Reunion Island increased fourfold between 1995 and 2015. In 2015, it was estimated at nearly 30.0 new cases per 100,000 inhabitants in people with skin phototypes I-III, compared to 13.5 in metropolitan France.
Over the course of a lifetime, 80% of exposure to UV radiation and 50% of skin damage occur before the age of 21, mainly in the school environment. In spite of this, knowledge of the risks associated with sun exposure remains insufficient among children and adolescents. Similar quantitative data have been reported for Reunion Island by the local association MiSolRé (Mission Soleil Réunion), which has been running sun safety campaigns in elementary schools since 2017. However, methodological limitations compromise the validity and extrapolation of the results. And the question arises as to the type of programme to be implemented: strengthening individual skills through health education methods? Community reinforcement through training activities involving peers? Improving access to prevention? Thus, it seems necessary to rigorously evaluate the effectiveness of different actions such as the educational programme "Vivre avec le soleil" alone or associated with the visit of professionals in the field with or without distribution of photoprotection material. The aim of this randomized controlled trial is to evaluate the effectiveness of three awareness-raising programmes on the risks linked to sun exposure, delivered in primary school classes in Reunion Island, on the pupils' knowledge of sun prevention.
- Conditions
- Melanoma
- Being tested
- MISOLRE prevention program on sun risks, "Vivre avec le Soleil" prevention program on sun risks, Sun protection equipment
- Keywords
- School, Environment, Preventive medicine and public health, Children's health, Sun protection factor
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MISOLRE prevention program on sun risksOther
Training of an ambassador class by a field coordinator Dissemination of the information by the ambassador class to the other classes of the school drawn by lot Transmission of an information document to parents on photoprotection to make them aware of the actions to adopt
"Vivre avec le Soleil" prevention program on sun risksOther
Program is delivered directly by the teachers through pedagogical books : 10 workshops over a period of 3 months
Sun protection equipmentOther
Distribution of sunscreen, caps and sunglasses
| Study group | Role | What they receive |
|---|---|---|
| Reference Arm | No intervention | no preventive action |
| Vivre avec le Soleil | Experimental | Use of existing validated program "vivre avec le soleil" Receives: Other: "Vivre avec le Soleil" prevention program on sun risks |
| Vivre avec le Soleil + program of MISOLRE association | Experimental | Use of existing validated program "vivre avec le soleil" associated with prevention awareness program of MISOLRE association Receives: Other: MISOLRE prevention program on sun risks; Other: "Vivre avec le Soleil" prevention program on sun risks |
| Vivre avec le Soleil + program of MISOLRE association + sun protections | Experimental | Use of existing validated program "vivre avec le soleil" associated with prevention awareness program of MISOLRE association and with the distribution of caps, sunscreens and sunglasses Receives: Other: MISOLRE prevention program on sun risks; Other: "Vivre avec le Soleil" prevention program on sun risks; Other: Sun protection equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of 3 programs of awareness of the risks related to sun exposure, delivered in primary school classes in Reunion Island, on students' knowledge of sun prevention
self questionnaire completed by the students. Comparison of pourcentage of good response to knowledge questionnaire in the 4 arms. No minimum or maximum score.
Measured: 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start31 Aug 2022
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies 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
- Masking
- None (open label)
- Enrolment
- 1,452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine BERTOLOTTI, Principal investigator, CHU de La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367180
- Sponsor's protocol ID
- 2022/CHU/09
- Acronym
- PRESOLRE
- Status last verified
- Oct 2023
- First submitted
- 5 May 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dugast C, Bruneau L, Fianu A, Ferdynus C, Boussaid K, Vuichard J, Duloutre F, Dumez J, Sultan-Bichat N, Bertolotti A. PRESOLRE: study protocol for a primary school-based, cluster randomised controlled trial of three sun exposure risk prevention strategies on Reunion Island. BMJ Open. 2024 May 15;14(5):e082045. doi: 10.1136/bmjopen-2023-082045.
PubMed 38754877
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Prevention Program on Sun Risks in Primary School in Tropical French Region
- ClinicalTrials.gov ID
- NCT05367180
- Acronym / sponsor ID
- PRESOLRE / 2022/CHU/09
- Conditions
- Melanoma
- Keywords
- School, Environment, Preventive medicine and public health, Children's health, Sun protection factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,452 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 May 2022 (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.
Sun exposure during childhood can cause the development of skin cancer in later years, in particular melanoma, which is the most lethal.The worldwide incidence of melanoma is on the rise, with nearly 290,000 new cases diagnosed in 2018. The country with the highest age-standardized incidence rate is Australia, where 40.4 cases per 100,000 men and 27.5 cases per 100,000 women were reported in 2018. Since 2008, however, this incidence has decreased by 11% in the 14-49 age group following the implementation of effective sun safety campaigns. In the French overseas department of Reunion Island, which is characterized by a great diversity of skin phototypes due to multiple migratory flows, the ultraviolet (UV) index is very high - equivalent to that in Australia. The age-standardized incidence rate of melanoma Reunion Island increased fourfold between 1995 and 2015. In 2015, it was estimated at nearly 30.0 new cases per 100,000 inhabitants in people with skin phototypes I-III, compared to 13.5 in metropolitan France.
Over the course of a lifetime, 80% of exposure to UV radiation and 50% of skin damage occur before the age of 21, mainly in the school environment. In spite of this, knowledge of the risks associated with sun exposure remains insufficient among children and adolescents. Similar quantitative data have been reported for Reunion Island by the local association MiSolRé (Mission Soleil Réunion), which has been running sun safety campaigns in elementary schools since 2017. However, methodological limitations compromise the validity and extrapolation of the results. And the question arises as to the type of programme to be implemented: strengthening individual skills through health education methods? Community reinforcement through training activities involving peers? Improving access to prevention? Thus, it seems necessary to rigorously evaluate the effectiveness of different actions such as the educational programme "Vivre avec le soleil" alone or associated with the visit of professionals in the field with or without distribution of photoprotection material. The aim of this randomized controlled trial is to evaluate the effectiveness of three awareness-raising programmes on the risks linked to sun exposure, delivered in primary school classes in Reunion Island, on the pupils' knowledge of sun prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reference Arm | No intervention | –no preventive action |
| Vivre avec le Soleil | Experimental | Other: "Vivre avec le Soleil" prevention program on sun risksUse of existing validated program "vivre avec le soleil" |
| Vivre avec le Soleil + program of MISOLRE association | Experimental | Other: MISOLRE prevention program on sun risks, Other: "Vivre avec le Soleil" prevention program on sun risksUse of existing validated program "vivre avec le soleil" associated with prevention awareness program of MISOLRE association |
| Vivre avec le Soleil + program of MISOLRE association + sun protections | Experimental | Other: MISOLRE prevention program on sun risks, Other: "Vivre avec le Soleil" prevention program on sun risks, Other: Sun protection equipmentUse of existing validated program "vivre avec le soleil" associated with prevention awareness program of MISOLRE association and with the distribution of caps, sunscreens and sunglasses |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- students in a primary school in Reunion Island, drawn by lot for the study and whose school director agrees to participate in the program
- in a primary school with more than 10 classes
- within a class from the second and the third cycle: CE (elementary course) 1, CE2, CM (average course) 1 or CM2
- whose 2 parents have given their consent
Key exclusion criteria (3 listed)
- in a school that has already benefited from the awareness program by the MiSolRé association in 2016/2017, 2017/2018, 2019/2020, 2020/2021
- in CP (preparatory course) class
- in a multi-level class
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 |
|---|---|---|
| MISOLRE prevention program on sun risksTraining of an ambassador class by a field coordinator Dissemination of the information by the ambassador class to the other classes of the school drawn by lot Transmission of an information document to parents on photoprotection to make them aware of the actions to adopt | Other | Vivre avec le Soleil + program of MISOLRE association, Vivre avec le Soleil + program of MISOLRE association + sun protections |
| "Vivre avec le Soleil" prevention program on sun risksProgram is delivered directly by the teachers through pedagogical books : 10 workshops over a period of 3 months | Other | Vivre avec le Soleil, Vivre avec le Soleil + program of MISOLRE association, Vivre avec le Soleil + program of MISOLRE association + sun protections |
| Sun protection equipmentDistribution of sunscreen, caps and sunglasses | Other | Vivre avec le Soleil + program of MISOLRE association + sun protections |
Primary outcome
Effectiveness of 3 programs of awareness of the risks related to sun exposure, delivered in primary school classes in Reunion Island, on students' knowledge of sun prevention
Time frame: 6 months after inclusion
self questionnaire completed by the students. Comparison of pourcentage of good response to knowledge questionnaire in the 4 arms. No minimum or maximum score.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Derived from this study: PubMed 38754877Dugast C, Bruneau L, Fianu A, Ferdynus C, Boussaid K, Vuichard J, Duloutre F, Dumez J, Sultan-Bichat N, Bertolotti A. PRESOLRE: study protocol for a primary school-based, cluster randomised controlled trial of three sun exposure risk prevention strategies on Reunion Island. BMJ Open. 2024 May 15;14(5):e082045. doi: 10.1136/bmjopen-2023-082045.
- 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.
Antoine BERTOLOTTI principal investigator
CHU de La Réunion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MISOLRE prevention program on sun risks, "Vivre avec le Soleil" prevention program on sun risks and Sun protection equipment in people with Melanoma, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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 4 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: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of 3 programs of awareness of the risks related to sun exposure, delivered in primary school classes in Reunion Island, on students' knowledge of sun prevention (time frame: 6 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05367180, which also lists 1 linked publication.
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 29 Feb 2024.