Breast Neoplasms Diagnosis
Conditions
Keywords
Breast neoplasms, prevention & control Cancer prevention, Risk reduction behavior, Night shift work, Personalized prevention, Risk assessment
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.
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
BEHAVIORALPersonalized Prevention Plan
Personalized recommendations for night shift workers targeting modifiable risk factors, including lifestyle, diet, physical activity, smoking, alcohol consumption, and adherence to screening
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Personalized Prevention Plan established during the initial risk assessment consultation | 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
| Measure | Time frame | Description |
|---|---|---|
| Overal patient satisfaction | 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" |
| Participant satisfaction with the adapted consultation to night work | 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". |
| Screening adherence to a cardiovascular consultation recommendation | At 1, 2, 3 and 5 years. | Proportion of participants who had the consultation with a cardiologist when recommended |
| Screening adherence to a fertility consultation consultation recommendation | At 1, 2, 3 and 5 years. | Proportion of participants who had the consultation with a cardiologist when recommended |
Countries
France
Contacts
CONTACTAmelia FAVIER, MD
PRINCIPAL_INVESTIGATORAmelia FAVIER, MD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed