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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant or breastfeeding women

Individuals under legal protection or deprived of liberty

Individuals without standard health insurance coverage

Trial population

The target population consists of female night staff at Pitié-Salpêtrière Hospital

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Participants with Personalized Prevention Plan1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Overal patient satisfaction

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"

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

Participant satisfaction with the adapted consultation to night work

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".

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

Screening adherence to a cardiovascular consultation recommendation

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

Time frame
At 1, 2, 3 and 5 years.
4

Screening adherence to a fertility consultation consultation recommendation

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

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

Other outcomes

Sponsors and contacts

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