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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Amelia FAVIER, MD
- Telefonnummer: +33 +331.42.17.81.14
- E-post: amelia.favier@aphp.fr
Studiesteder
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Paris, Frankrike, 75013
- Rekruttering
- Pitié Salpetrière Hospital
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Ta kontakt med:
- Amelia FAVIER, MD
- Telefonnummer: +33 +33.1.42.17.81.11
- E-post: amelia.favier@aphp.fr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Adherence to Personalized Prevention Plan established during the initial risk assessment consultation
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Overal patient satisfaction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Amelia FAVIER, MD, Assistance Publique - Hôpitaux de Paris
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- APHP260459
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
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