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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Amelia FAVIER, MD
- Telefonnummer: +33 +331.42.17.81.14
- E-post: amelia.favier@aphp.fr
Studieorter
-
-
-
Paris, Frankrike, 75013
- Rekrytering
- Pitié Salpetrière Hospital
-
Kontakt:
- Amelia FAVIER, MD
- Telefonnummer: +33 +33.1.42.17.81.11
- E-post: amelia.favier@aphp.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Participants with Personalized Prevention Plan
Participants receive a tailored prevention plan following risk assessment
|
Personalized recommendations for night shift workers targeting modifiable risk factors, including lifestyle, diet, physical activity, smoking, alcohol consumption, and adherence to screening
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Adherence to Personalized Prevention Plan established during the initial risk assessment consultation
Tidsram: At 1, 2, 3 and 5 years.
|
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.
|
At 1, 2, 3 and 5 years.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overal patient satisfaction
Tidsram: At 1, 2, 3 and 5 years
|
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"
|
At 1, 2, 3 and 5 years
|
|
Participant satisfaction with the adapted consultation to night work
Tidsram: At 1, 2, 3 and 5 years.
|
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".
|
At 1, 2, 3 and 5 years.
|
|
Screening adherence to a cardiovascular consultation recommendation
Tidsram: At 1, 2, 3 and 5 years.
|
Proportion of participants who had the consultation with a cardiologist when recommended
|
At 1, 2, 3 and 5 years.
|
|
Screening adherence to a fertility consultation consultation recommendation
Tidsram: At 1, 2, 3 and 5 years.
|
Proportion of participants who had the consultation with a cardiologist when recommended
|
At 1, 2, 3 and 5 years.
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Amelia FAVIER, MD, Assistance Publique - Hôpitaux de Paris
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- APHP260459
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .