Breast Cancer Risk Assessment in Night Shift Workers - Implementation of a Personalized Consultation (NIGHT-SCAN)
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Amelia FAVIER, MD
- 电话号码：+33 +331.42.17.81.14
- 邮箱：amelia.favier@aphp.fr
学习地点
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Paris、法国、75013
- 招聘中
- Pitié Salpetrière Hospital
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接触：
- Amelia FAVIER, MD
- 电话号码：+33 +33.1.42.17.81.11
- 邮箱：amelia.favier@aphp.fr
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Participants with Personalized Prevention Plan
Participants receive a tailored prevention plan following risk assessment
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Personalized recommendations for night shift workers targeting modifiable risk factors, including lifestyle, diet, physical activity, smoking, alcohol consumption, and adherence to screening
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Adherence to Personalized Prevention Plan established during the initial risk assessment consultation
大体时间：At 1, 2, 3 and 5 years.
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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.
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At 1, 2, 3 and 5 years.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overal patient satisfaction
大体时间：At 1, 2, 3 and 5 years
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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"
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At 1, 2, 3 and 5 years
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Participant satisfaction with the adapted consultation to night work
大体时间：At 1, 2, 3 and 5 years.
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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".
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At 1, 2, 3 and 5 years.
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Screening adherence to a cardiovascular consultation recommendation
大体时间：At 1, 2, 3 and 5 years.
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Proportion of participants who had the consultation with a cardiologist when recommended
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At 1, 2, 3 and 5 years.
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Screening adherence to a fertility consultation consultation recommendation
大体时间：At 1, 2, 3 and 5 years.
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Proportion of participants who had the consultation with a cardiologist when recommended
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At 1, 2, 3 and 5 years.
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合作者和调查者
调查人员
- 首席研究员：Amelia FAVIER, MD、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- APHP260459
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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.
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
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