Breast Cancer Risk Assessment in Night Shift Workers - Implementation of a Personalized Consultation
NIGHT-SCAN
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2026
CompletedFirst Posted
Study publicly available on registry
June 5, 2026
CompletedStudy Start
First participant enrolled
July 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 8, 2032
July 16, 2026
May 1, 2026
6 years
May 18, 2026
July 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence to Personalized Prevention Plan established during the initial risk assessment consultation
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.
Secondary Outcomes (4)
Overal patient satisfaction
At 1, 2, 3 and 5 years
Participant satisfaction with the adapted consultation to night work
At 1, 2, 3 and 5 years.
Screening adherence to a cardiovascular consultation recommendation
At 1, 2, 3 and 5 years.
Screening adherence to a fertility consultation consultation recommendation
At 1, 2, 3 and 5 years.
Study Arms (1)
Participants with Personalized Prevention Plan
Participants receive a tailored prevention plan following risk assessment
Interventions
Personalized recommendations for night shift workers targeting modifiable risk factors, including lifestyle, diet, physical activity, smoking, alcohol consumption, and adherence to screening
Eligibility Criteria
The target population consists of female night staff at Pitié-Salpêtrière Hospital
You may qualify if:
- 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)
You may not qualify if:
- Pregnant or breastfeeding women
- Individuals under legal protection or deprived of liberty
- Individuals without standard health insurance coverage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pitié Salpêtrière hospital
Paris, 75013, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amelia FAVIER, MD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2026
First Posted
June 5, 2026
Study Start
July 8, 2026
Primary Completion (Estimated)
July 8, 2032
Study Completion (Estimated)
July 8, 2032
Last Updated
July 16, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal.
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.