PRESOLRE: study protocol for a primary school-based, cluster randomised controlled trial of three sun exposure risk prevention strategies on Reunion Island
Introduction 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...
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BMJ Publishing Group
2024-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/5/e082045.full |
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| author | Cyril Ferdynus Léa Bruneau Antoine Bertolotti Charline Dugast Adrian Fianu Karim Boussaid Juliette Vuichard Floreana Duloutre Jessica Dumez Nathalie Sultan-Bichat |
| author_facet | Cyril Ferdynus Léa Bruneau Antoine Bertolotti Charline Dugast Adrian Fianu Karim Boussaid Juliette Vuichard Floreana Duloutre Jessica Dumez Nathalie Sultan-Bichat |
| author_sort | Cyril Ferdynus |
| collection | DOAJ |
| description | Introduction 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 and analysis 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.Ethics and dissemination The study obtained ethics approval in 2022 (ID: 2022-A00350-43). Results will be published in peer-reviewed journals.Trial registration number NCT05367180. |
| format | Article |
| id | doaj-art-c2acddb02fcd4e85aeaad5b01c063ae2 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-c2acddb02fcd4e85aeaad5b01c063ae22025-08-20T03:40:22ZengBMJ Publishing GroupBMJ Open2044-60552024-05-0114510.1136/bmjopen-2023-082045PRESOLRE: study protocol for a primary school-based, cluster randomised controlled trial of three sun exposure risk prevention strategies on Reunion IslandCyril Ferdynus0Léa Bruneau1Antoine Bertolotti2Charline Dugast3Adrian Fianu4Karim Boussaid5Juliette Vuichard6Floreana Duloutre7Jessica Dumez8Nathalie Sultan-Bichat91 Center for Clinical Investigation (CIC) 14 10 Clinical Epidemiology National Institute of Health and Medical Research (INSERM), Reunion University Hospital, Saint Pierre, Reunion Island, France1 Center for Clinical Investigation (CIC) 14 10 Clinical Epidemiology National Institute of Health and Medical Research (INSERM), Reunion University Hospital, Saint Pierre, Reunion Island, France1 Center for Clinical Investigation (CIC) 14 10 Clinical Epidemiology National Institute of Health and Medical Research (INSERM), Reunion University Hospital, Saint Pierre, Reunion Island, France1 Center for Clinical Investigation (CIC) 14 10 Clinical Epidemiology National Institute of Health and Medical Research (INSERM), Reunion University Hospital, Saint Pierre, Reunion Island, France1 Center for Clinical Investigation (CIC) 14 10 Clinical Epidemiology National Institute of Health and Medical Research (INSERM), Reunion University Hospital, Saint Pierre, Reunion Island, France1 Center for Clinical Investigation (CIC) 14 10 Clinical Epidemiology National Institute of Health and Medical Research (INSERM), Reunion University Hospital, Saint Pierre, Reunion Island, France1 Center for Clinical Investigation (CIC) 14 10 Clinical Epidemiology National Institute of Health and Medical Research (INSERM), Reunion University Hospital, Saint Pierre, Reunion Island, France1 Center for Clinical Investigation (CIC) 14 10 Clinical Epidemiology National Institute of Health and Medical Research (INSERM), Reunion University Hospital, Saint Pierre, Reunion Island, France1 Center for Clinical Investigation (CIC) 14 10 Clinical Epidemiology National Institute of Health and Medical Research (INSERM), Reunion University Hospital, Saint Pierre, Reunion Island, France3 Dermatology Department, West Reunion University Hospital, Saint Paul, Reunion Island, FranceIntroduction 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 and analysis 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.Ethics and dissemination The study obtained ethics approval in 2022 (ID: 2022-A00350-43). Results will be published in peer-reviewed journals.Trial registration number NCT05367180.https://bmjopen.bmj.com/content/14/5/e082045.full |
| spellingShingle | Cyril Ferdynus Léa Bruneau Antoine Bertolotti Charline Dugast Adrian Fianu Karim Boussaid Juliette Vuichard Floreana Duloutre Jessica Dumez Nathalie Sultan-Bichat PRESOLRE: study protocol for a primary school-based, cluster randomised controlled trial of three sun exposure risk prevention strategies on Reunion Island BMJ Open |
| title | PRESOLRE: study protocol for a primary school-based, cluster randomised controlled trial of three sun exposure risk prevention strategies on Reunion Island |
| title_full | PRESOLRE: study protocol for a primary school-based, cluster randomised controlled trial of three sun exposure risk prevention strategies on Reunion Island |
| title_fullStr | PRESOLRE: study protocol for a primary school-based, cluster randomised controlled trial of three sun exposure risk prevention strategies on Reunion Island |
| title_full_unstemmed | PRESOLRE: study protocol for a primary school-based, cluster randomised controlled trial of three sun exposure risk prevention strategies on Reunion Island |
| title_short | PRESOLRE: study protocol for a primary school-based, cluster randomised controlled trial of three sun exposure risk prevention strategies on Reunion Island |
| title_sort | presolre study protocol for a primary school based cluster randomised controlled trial of three sun exposure risk prevention strategies on reunion island |
| url | https://bmjopen.bmj.com/content/14/5/e082045.full |
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