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NCT Number: NCT07630935

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

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.

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Key information

Conditions

Breast Neoplasms Diagnosis Behavior Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Risk Reduction Behavior Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized Prevention Plan

Behavioral

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

Primary outcomes

  1. Adherence to Personalized Prevention Plan established during the initial risk assessment consultation

    Time frame: 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.

Secondary outcomes

  1. Overal patient satisfaction

    Time frame: 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"

  2. Participant satisfaction with the adapted consultation to night work

    Time frame: 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".

  3. Screening adherence to a cardiovascular consultation recommendation

    Time frame: At 1, 2, 3 and 5 years.

    Proportion of participants who had the consultation with a cardiologist when recommended

  4. Screening adherence to a fertility consultation consultation recommendation

    Time frame: At 1, 2, 3 and 5 years.

    Proportion of participants who had the consultation with a cardiologist when recommended

Study contacts

Contact information is provided by the study sponsor or research team.

Amelia FAVIER, MD

CONTACT

[email protected]

+331.42.17.81.14 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: NIGHT-SCAN

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Jun 5, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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