Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-11 @ 1:29 PM
Study NCT ID:
NCT05316402
Status:
UNKNOWN
Last Update Posted:
2022-04-07
First Post:
2022-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sun Exposure for Outdoor Athletes in Mayotte and Reunion Island
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011874', 'term': 'Radiometry'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2022-03-14', 'studyFirstSubmitQcDate': '2022-04-04', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improve the knowledge of photo-exposed sportsmen on the risks associated with exposure to the sun', 'timeFrame': '6 month', 'description': 'knowledge quiz'}], 'secondaryOutcomes': [{'measure': 'Assess the change in attitudes and practices of photo-exposed sportsmen', 'timeFrame': '6 month', 'description': 'attitudes and practices of photo-exposed workers quiz'}, {'measure': 'fitzpatrick scale : classification of skin types (phototype I to VI)', 'timeFrame': '6 month', 'description': 'association between phototype and knowledge level'}, {'measure': 'knowledge questionnaire on the risks of sun exposure', 'timeFrame': '6 month', 'description': 'association between phototype and knowledge level'}, {'measure': 'Obtain UV dosimetry data by occupation to confirm risk exposure during working hours.', 'timeFrame': '6 month', 'description': 'dosimetry data'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sun Exposure, sportsmen'], 'conditions': ['Sun Exposure']}, 'descriptionModule': {'briefSummary': 'The UV index in Mayotte and Reunion is greater than 14, eight months out of 12. This index decreases linearly over the period from mid-April to mid-August where it can drop to reach an index of 8 in the month of July. The inhabitants are therefore exposed to a maximum intensity of UV radiation according to the WHO.\n\nThe World Health Organization (WHO) recommends extreme precautions for indices greater than 11 (avoid exposure between 11 a.m. and 3 p.m. (GMT+3 hours), stay in the shade, wear a t-shirt, sunglasses, hat and sunscreen).\n\nSun exposure is a major risk factor in the development of skin cancer, basal cell cancer, squamous cell cancer and cutaneous melanoma. It is also the cause of premature aging of the skin. Moreover, it causes ocular complications such as the occurrence of cataracts and this without distinction of skin phenotype.\n\nThere is currently no prevention campaign on the risks of sun exposure in Mayotte or Reunion for adults, while many risky behaviors are observed both in the professional field and during leisure activities. In order to better understand risk-taking and choose appropriate awareness-raising tools, it is necessary to identify the knowledge, attitudes and practices (KAP) of these populations in terms of risk of sun exposure and to measure the impact of solar prevention education actions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Live in Mayotte or Reunion island\n* 18 years old,\n* Practice outdoor sports \\> 4 hours per week in one of the identified sports associations\n* Belong to the list of targeted associations\n\nExclusion Criteria:\n\n* Person deprived of liberty by judicial or administrative decision, minor, and person subject to a legal protection measure: guardianship or curators\n* Person not wishing to participate\n* No one speaking any of the following languages: English / French / Shimaore / Kibushi / Creole or Comorian\n* Person who cannot be followed during the 6 months of the study\n* Inability to answer the questionnaire'}, 'identificationModule': {'nctId': 'NCT05316402', 'acronym': 'EXSPOSOL', 'briefTitle': 'Sun Exposure for Outdoor Athletes in Mayotte and Reunion Island', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Sun Exposure for Outdoor Athletes in Mayotte and Reunion Island', 'orgStudyIdInfo': {'id': '2021/CHU/39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'training on the risks associated with sun exposure', 'description': 'power point on the risks associated with sun exposure', 'interventionNames': ['Other: training on the risks associated with sun exposure', 'Other: dosimetry']}], 'interventions': [{'name': 'training on the risks associated with sun exposure', 'type': 'OTHER', 'description': '15-minute power point and presentation on the risks of sun exposure', 'armGroupLabels': ['training on the risks associated with sun exposure']}, {'name': 'dosimetry', 'type': 'OTHER', 'description': 'dosimetry', 'armGroupLabels': ['training on the risks associated with sun exposure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chirongui', 'country': 'Mayotte', 'contacts': [{'name': 'Lucie AUZANNEAU', 'role': 'CONTACT'}, {'name': 'Jessica DUMEZ, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayotte', 'geoPoint': {'lat': -12.93194, 'lon': 45.14833}}, {'city': 'Saint-Pierre', 'country': 'Reunion', 'contacts': [{'name': 'Lucie AUZANNEAU', 'role': 'CONTACT'}, {'name': 'Antoine BERTOLOTTI, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Reunion', 'geoPoint': {'lat': -21.3393, 'lon': 55.47811}}], 'centralContacts': [{'name': 'Lucie AUZANNEAU', 'role': 'CONTACT', 'email': 'lucie.auzanneau@chu-reunion.fr', 'phone': '0262359949', 'phoneExt': '+262'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}