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

Melanoma Clinical Trial

— PRESOLRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05367180
• Other study ID #: 2022/CHU/09
• Status: Completed
• Phase: N/A
• Start date: August 31, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 information / eligibility

• Status: Completed
• Enrollment: 1452
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

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
• "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
• Sun protection equipment
Distribution of sunscreen, caps and sunglasses

Locations

Country	Name	City	State
Réunion	CHU de La Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months after inclusion