PDF(Pubmed)
Abstract：
BACKGROUND: 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.
METHODS: 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.
BACKGROUND: The study obtained ethics approval in 2022 (ID: 2022-A00350-43). Results will be published in peer-reviewed journals.
BACKGROUND: NCT05367180.
METHODS: 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.
BACKGROUND: The study obtained ethics approval in 2022 (ID: 2022-A00350-43). Results will be published in peer-reviewed journals.
BACKGROUND: NCT05367180.
摘要：
背景：留尼汪岛，法国海外部门，位于南半球，靠近摩羯座热带。这个岛上有一个多元文化和多种族的人口，有860,000居民，由于强烈的紫外线辐射，其中四分之一的人患皮肤癌的风险很高。黑色素瘤是大多数皮肤癌死亡的原因。黑色素瘤的早期预防是基于儿童的防晒，但是法国的法规不适应这个热带地区的环境条件。我们研究的主要目的是通过学生知识问卷评估在Reunionese小学进行的三个防晒计划的有效性。
方法：PRESOLRE是一种介入，开放标签，集群随机对照试验，在四个平行臂中，这是整个2022-2023年在留尼汪岛进行的。试验设计假设使用以下方法进行升级干预效果：首先，没有建议干预的控制臂(臂1)；第二，鼓励其课程使用经过验证的教育计划“与太阳一起生活”（LWS）的手臂（手臂2）；第三，鼓励班级同时使用“LWS”和“MissionSoleilRéunion的防晒意识计划”的手臂（手臂3）；第四，受益于类似于手臂3的干预的手臂，结合帽子的分布，太阳镜和防晒霜（手臂4）。总之,来自18个班级的20名学生的1780名学生，平均而言,将包括在内。随机化适用于学生的类别(如此定义为集群)。主要结果是基于意识计划后知识问题的正确答案的比例，使用具有随机截距的线性混合模型在四个臂之间进行比较。
背景：该研究于2022年获得伦理学批准（ID：2022-A00350-43）。结果将发表在同行评审的期刊上。
背景：NCT05367180。
方法：PRESOLRE是一种介入，开放标签，集群随机对照试验，在四个平行臂中，这是整个2022-2023年在留尼汪岛进行的。试验设计假设使用以下方法进行升级干预效果：首先，没有建议干预的控制臂(臂1)；第二，鼓励其课程使用经过验证的教育计划“与太阳一起生活”（LWS）的手臂（手臂2）；第三，鼓励班级同时使用“LWS”和“MissionSoleilRéunion的防晒意识计划”的手臂（手臂3）；第四，受益于类似于手臂3的干预的手臂，结合帽子的分布，太阳镜和防晒霜（手臂4）。总之,来自18个班级的20名学生的1780名学生，平均而言,将包括在内。随机化适用于学生的类别(如此定义为集群)。主要结果是基于意识计划后知识问题的正确答案的比例，使用具有随机截距的线性混合模型在四个臂之间进行比较。
背景：该研究于2022年获得伦理学批准（ID：2022-A00350-43）。结果将发表在同行评审的期刊上。
背景：NCT05367180。
