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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Amelia FAVIER, MD
- Numer telefonu: +33 +331.42.17.81.14
- E-mail: amelia.favier@aphp.fr
Lokalizacje studiów
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Paris, Francja, 75013
- Rekrutacyjny
- Pitié Salpetrière Hospital
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Kontakt:
- Amelia FAVIER, MD
- Numer telefonu: +33 +33.1.42.17.81.11
- E-mail: amelia.favier@aphp.fr
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Adherence to Personalized Prevention Plan established during the initial risk assessment consultation
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Overal patient satisfaction
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Śledczy
- Główny śledczy: Amelia FAVIER, MD, Assistance Publique - Hôpitaux de Paris
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- APHP260459
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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