NCT05367180

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,452

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

August 31, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 29, 2024

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

May 5, 2022

Last Update Submit

February 28, 2024

Conditions

Melanoma

Keywords

SchoolEnvironmentPreventive medicine and public healthChildren's healthSun protection factor

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Reference Arm

NO INTERVENTION

no preventive action

Vivre avec le Soleil

EXPERIMENTAL

Use of existing validated program "vivre avec le soleil"

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

Other: MISOLRE prevention program on sun risksOther: "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

Other: MISOLRE prevention program on sun risksOther: "Vivre avec le Soleil" prevention program on sun risksOther: Sun protection equipment

Interventions

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 + program of MISOLRE associationVivre avec le Soleil + program of MISOLRE association + sun protections
"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

Vivre avec le SoleilVivre avec le Soleil + program of MISOLRE associationVivre avec le Soleil + program of MISOLRE association + sun protections
Sun protection equipmentOTHER

Distribution of sunscreen, caps and sunglasses

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

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de La Réunion

Saint-Pierre, Reunion

Location

Related Publications (1)

  • 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.

    PMID: 38754877DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Antoine BERTOLOTTI

    CHU de La Réunion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 10, 2022

Study Start

August 31, 2022

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

February 29, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

RE(1)