Center for Clinical Investigation (CIC) 14 10 Clinical Epidemiology National Institute of Health and Medical Research (INSERM), Reunion University Hospital, Saint Pierre, Reunion Island, France.
Center for Clinical Investigation (CIC) 14 10 Clinical Epidemiology National Institute of Health and Medical Research (INSERM), Reunion University Hospital, Saint Pierre, Reunion Island, France
BMJ Open. 2024 May 15;14(5):e082045. doi: 10.1136/bmjopen-2023-082045.
Reunion Island, a French overseas department, is located in the southern hemisphere, close to the Capricorn tropic. This island has a multicultural and multiethnic population of 860 000 inhabitants, a quarter of whom are at high risk of developing skin cancer due to intense ultraviolet radiation. Melanoma is responsible for the majority of skin cancer deaths. The early prevention of melanoma is based on sun protection in childhood, but French regulations are not adapted to the environmental conditions of this tropical region.The main objective of our study is to evaluate the effectiveness of three sun protection programs conducted in Reunionese primary schools through a pupil knowledge questionnaire.
PRESOLRE is an interventional, open-label, cluster-randomised controlled trial, in four parallel arms, that is being conducted throughout 2022-2023 on Reunion Island. The trial design assumes an escalation interventional effect using: first, a control arm without proposed intervention (arm 1); second, an arm whose classes are encouraged to use the validated educational programme 'Living With the Sun' (LWS) (arm 2); third, an arm whose classes are encouraged to use both 'LWS' combined with 'Mission Soleil Réunion's sun protection awareness programme (arm 3); fourth, an arm benefiting from an intervention similar to arm 3, combined with the distribution of hats, sunglasses and sun creams (arm 4). In all, 1780 pupils from 18 classes of 20 pupils, on average, will be included. Randomisation applies to the classes of pupils (so defined as clusters). The primary outcome is based on the proportion of correct answers to the knowledge questions after the awareness programme, compared between the four arms using a linear mixed model with random intercept.
The study obtained ethics approval in 2022 (ID: 2022-A00350-43). Results will be published in peer-reviewed journals.
NCT05367180.
留尼汪岛，法国海外省，位于南半球，靠近摩羯座回归线。这座岛屿拥有一个多元文化和多民族的 86 万居民群体，其中四分之一的人由于强烈的紫外线辐射，存在罹患皮肤癌的高风险。黑色素瘤是导致大多数皮肤癌死亡的原因。早期预防黑色素瘤的方法是在儿童时期进行防晒，但法国的法规并不适应于这个热带地区的环境条件。我们的主要研究目的是通过小学生知识问卷，评估在留尼汪岛的小学中开展的三个防晒计划的效果。
PRESOLRE 是一项干预性、开放性、整群随机对照试验，在四个平行组中进行，于 2022-2023 年在留尼汪岛进行。该试验设计假设采用逐步递增的干预效果，首先采用无干预的对照组（第 1 组）；其次，鼓励使用经过验证的教育计划“与太阳共存”（LWS）的组（第 2 组）；再次，鼓励使用“LWS”与“留尼汪岛太阳保护意识计划”（Mission Soleil Réunion）联合的组（第 3 组）；最后，受益于与第 3 组类似的干预措施，并结合分发帽子、太阳镜和防晒霜的组（第 4 组）。总共将纳入来自 18 个 20 名学生的班级的 1780 名学生。随机化适用于学生班级（即定义为群组）。主要结果是基于在意识计划后，知识问题的正确答案比例，使用具有随机截距的线性混合模型，在四个组之间进行比较。
该研究于 2022 年获得了伦理批准（ID：2022-A00350-43）。结果将发表在同行评议的期刊上。
NCT05367180。
