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Recruiting NCT07630935

Breast Cancer Risk Assessment in Night Shift Workers - Implementation of a Personalized Consultation

Observational Breast Neoplasms Diagnosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Personalized Prevention Plan.
Who it may be relevant to
Registry conditions: Breast Neoplasms Diagnosis. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Personalized Prevention Plan
    Personalized recommendations for night shift workers targeting modifiable risk factors, including lifestyle, diet, physical activity, smoking, alcohol consumption, and adherence to screening

Primary outcome measures

  • Adherence to Personalized Prevention Plan established during the initial risk assessment consultation [Time frame: At 1, 2, 3 and 5 years.]
Secondary outcome measures (4)
  • Overal patient satisfaction [Time frame: At 1, 2, 3 and 5 years]
  • Participant satisfaction with the adapted consultation to night work [Time frame: At 1, 2, 3 and 5 years.]
  • Screening adherence to a cardiovascular consultation recommendation [Time frame: At 1, 2, 3 and 5 years.]
  • Screening adherence to a fertility consultation consultation recommendation [Time frame: At 1, 2, 3 and 5 years.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Pitié Salpêtrière hospital — Paris

Identifiers

NCT: NCT07630935 · APHP260459

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗