The Impact of a Prevention Program on Sun Risks in Primary School in Tropical French Region

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The Impact of a Prevention Program on Sun Risks in Primary School in Tropical French Region

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	7 Years - 11 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05367180
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre Hospitalier Universitaire de la Réunion
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Antoine BERTOLOTTI
Principal Investigator Affiliation	CHU de La Réunion
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma

Arms & Interventions

Arms

No Intervention: Reference Arm

no preventive action

Experimental: Vivre avec le Soleil

Use of existing validated program "vivre avec le soleil"

Experimental: Vivre avec le Soleil + program of MISOLRE association

Use of existing validated program "vivre avec le soleil" associated with prevention awareness program of MISOLRE association

Experimental: Vivre avec le Soleil + program of MISOLRE association + sun protections

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

Interventions

Other: - MISOLRE prevention program on sun risks

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

Other: - "Vivre avec le Soleil" prevention program on sun risks

Program is delivered directly by the teachers through pedagogical books : 10 workshops over a period of 3 months

Other: - Sun protection equipment

Distribution of sunscreen, caps and sunglasses

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Antoine BERTOLLOTI

antoine.bertolotti@chu-reunion.fr

+262 262 35 91 65

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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