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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Personalized Prevention Plan | Participants receive a tailored prevention plan following risk assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | At 1, 2, 3 and 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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The target population consists of female night staff at Pitié-Salpêtrière Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amelia FAVIER, MD | Contact | +331.42.17.81.14 | +33 | amelia.favier@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Amelia FAVIER, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pitié Salpêtrière hospital | Paris | 75013 | France |
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.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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". |
| At 1, 2, 3 and 5 years. |
| Screening adherence to a cardiovascular consultation recommendation | Proportion of participants who had the consultation with a cardiologist when recommended | At 1, 2, 3 and 5 years. |
| Screening adherence to a fertility consultation consultation recommendation | Proportion of participants who had the consultation with a cardiologist when recommended | At 1, 2, 3 and 5 years. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |