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

Primary Purpose

Melanoma

Status
Completed
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
MISOLRE prevention program on sun risks
"Vivre avec le Soleil" prevention program on sun risks
Sun protection equipment
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Melanoma focused on measuring School, Environment, Preventive medicine and public health, Children's health, Sun protection factor

Eligibility Criteria

7 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de La Réunion

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Reference Arm

Vivre avec le Soleil

Vivre avec le Soleil + program of MISOLRE association

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

Arm Description

no preventive action

Use of existing validated program "vivre avec le soleil"

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2022
Last Updated
July 13, 2023
Sponsor
Centre Hospitalier Universitaire de la Réunion
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1. Study Identification

Unique Protocol Identification Number
NCT05367180
Brief Title
The Impact of a Prevention Program on Sun Risks in Primary School in Tropical French Region
Acronym
PRESOLRE
Official Title
Impact of a Prevention Program on Sun Risks in Primary School in Tropical French Region
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
School, Environment, Preventive medicine and public health, Children's health, Sun protection factor

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1472 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reference Arm
Arm Type
No Intervention
Arm Description
no preventive action
Arm Title
Vivre avec le Soleil
Arm Type
Experimental
Arm Description
Use of existing validated program "vivre avec le soleil"
Arm Title
Vivre avec le Soleil + program of MISOLRE association
Arm Type
Experimental
Arm Description
Use of existing validated program "vivre avec le soleil" associated with prevention awareness program of MISOLRE association
Arm Title
Vivre avec le Soleil + program of MISOLRE association + sun protections
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
MISOLRE prevention program on sun risks
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
"Vivre avec le Soleil" prevention program on sun risks
Intervention Description
Program is delivered directly by the teachers through pedagogical books : 10 workshops over a period of 3 months
Intervention Type
Other
Intervention Name(s)
Sun protection equipment
Intervention Description
Distribution of sunscreen, caps and sunglasses
Primary Outcome Measure Information:
Title
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
Description
self questionnaire completed by the students. Comparison of pourcentage of good response to knowledge questionnaire in the 4 arms. No minimum or maximum score.
Time Frame
6 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine BERTOLOTTI
Organizational Affiliation
CHU de La Réunion
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de La Réunion
City
Saint-Pierre
Country
Réunion

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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