- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05336422
Sun Exposure of Outdoor Workers in Mayotte and Reunion Island (EXTRASOL)
The UV index in Mayotte and Reunion is greater than 14, eight months out of twelve. This index decreases linearly over the period from mid-April to mid-August where it can drop to reach an index of 8 in July. The inhabitants are therefore exposed to a maximum intensity of UV radiation according to the World Health Organization (WHO).
The 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).
Sun 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. Furthermore, it causes ocular complications such as the occurrence of cataracts and this without distinction of skin phenotype.
There 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Saint-Pierre, Gjenforening
- Reunion
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Hovedetterforsker:
- Antoine BERTOLOTTI, MD,PhD
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-
-
-
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Chirongui, Mayotte
- Mayotte
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Underetterforsker:
- Jessica DUMEZ, MD, MSc
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Live in Mayotte or Reunion island
- > 18 years old
- Work outdoors > 2 hours a day in one of the identified professions
- Belong to the list of targeted companies
Exclusion Criteria:
- Person deprived of liberty by judicial or administrative decision, minor, and person subject to a legal protection measure: guardianship or curators
- Person not agreeing to participate
- No one speaking any of the following languages: English / French / Shimaore / Kibushi / Creole or Comorian
- Person who cannot be followed during the 6 months of the study
- Inability to answer the questionnaire
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: training on the risks associated with sun exposure
power point on the risks associated with sun exposure
|
15-minute power point and presentation on the risks of sun exposure
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assess the knowledge of photo-exposed workers on the risks associated with exposure to the sun.
Tidsramme: 6 month
|
knowledge quiz
|
6 month
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assess the change in attitudes and practices of photo-exposed workers
Tidsramme: 6 month
|
attitudes and practices of photo-exposed workers quiz
|
6 month
|
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fitzpatrick scale : classification of skin types (phototype I to VI)
Tidsramme: 6 month
|
phototype and knowledge level
|
6 month
|
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knowledge questionnaire
Tidsramme: 6 month
|
phototype and knowledge level
|
6 month
|
|
Obtain UV dosimetry data by occupation to confirm risk exposure during working hours.
Tidsramme: 6 month
|
dosimetry data
|
6 month
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2021/CHU/38
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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