Breast Cancer Risk Assessment in Night Shift Workers - Implementation of a Personalized Consultation (NIGHT-SCAN)
This study evaluates adherence to a personalized prevention plan in female night shift workers at increased risk of breast cancer. Night shift work is associated with circadian disruption and increased cancer risk, as well as cardiovascular and reproductive health risks.
Participants attend an initial consultation including clinical assessment and development of a personalized prevention plan targeting modifiable risk factors such as alcohol consumption, physical activity, smoking, diet, and weight.
Follow-up is conducted remotely over 5 years to assess adherence to recommendations and screening. Participant satisfaction and adherence to additional consultations are also evaluated.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Breast cancer is the most common cancer among women, and prognosis depends on early detection. Night shift work is associated with circadian rhythm disruption and increased cancer risk.
This single-center interventional study evaluates adherence to a personalized prevention plan (PPP) developed during an initial consultation. This consultation includes a review of medical history, a lifestyle assessment, and a physical examination.
The PPP targets modifiable risk factors, including smoking, alcohol consumption, diet, physical activity, and weight.
Participants are followed for 5 years, with assessments at 1, 2, 3, and 5 years. Adherence is defined as the implementation of at least one recommendation or the completion of prescribed screening tests.
Secondary objectives include assessing satisfaction with and adherence to cardiology and fertility consultations when recommended.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Amelia FAVIER, MD
- Numéro de téléphone: +33 +331.42.17.81.14
- E-mail: amelia.favier@aphp.fr
Lieux d'étude
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Paris, France, 75013
- Recrutement
- Pitié Salpetrière Hospital
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Contact:
- Amelia FAVIER, MD
- Numéro de téléphone: +33 +33.1.42.17.81.11
- E-mail: amelia.favier@aphp.fr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Female participants aged 18 years or older
- Night shift workers at Pitié-Salpêtrière Hospital
- Attending consultation for breast cancer risk assessment PGRC
- Affiliated with a social security system
- No personal history of breast cancer
- Provided informed consent (non-opposition procedure according to French regulations)
Exclusion Criteria:
- Pregnant or breastfeeding women
- Individuals under legal protection or deprived of liberty
- Individuals without standard health insurance coverage
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Participants with Personalized Prevention Plan
Participants receive a tailored prevention plan following risk assessment
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Personalized recommendations for night shift workers targeting modifiable risk factors, including lifestyle, diet, physical activity, smoking, alcohol consumption, and adherence to screening
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Adherence to Personalized Prevention Plan established during the initial risk assessment consultation
Délai: At 1, 2, 3 and 5 years.
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Proportion of participants adhering to at least one recommendation of the Personalized Prevention Plan or completing prescribed screening.
Percentage of participants who lost weight when overweight had been identified during the initial consultation.
Percentage of participants with modified sporting activity according to the recommendations at the initial consultation.
Percentage of participants who had quit smoking.
Percentage of participants who modified their alcohol consumption when it was excessive at the initial consultation.
Percentage of participants who changed their diets when a dietary imbalance was observed during the initial consultation.
Percentage of women who underwent screening as recommended following the initial consultation.
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At 1, 2, 3 and 5 years.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Overal patient satisfaction
Délai: At 1, 2, 3 and 5 years
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Patient satisfaction regarding the PPP will be assessed 1 year following the intervention using the validated "Patient Satisfaction Questionnaire Short Form (PSQ-18)", based on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree"
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At 1, 2, 3 and 5 years
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Participant satisfaction with the adapted consultation to night work
Délai: At 1, 2, 3 and 5 years.
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Satisfaction rate of women with the consultation system adapted to night.
Patient satisfaction will be assessed using the validated "Patient Satisfaction Questionnaire Short Form (PSQ-18)", based on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree".
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At 1, 2, 3 and 5 years.
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Screening adherence to a cardiovascular consultation recommendation
Délai: At 1, 2, 3 and 5 years.
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Proportion of participants who had the consultation with a cardiologist when recommended
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At 1, 2, 3 and 5 years.
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Screening adherence to a fertility consultation consultation recommendation
Délai: At 1, 2, 3 and 5 years.
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Proportion of participants who had the consultation with a cardiologist when recommended
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At 1, 2, 3 and 5 years.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Amelia FAVIER, MD, Assistance Publique - Hôpitaux de Paris
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- APHP260459
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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