Pilot Study on Lung Cancer Screening Implementation Among Employees at Lyon Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Participation rate at baseline
研究概览
简要总结
Several randomized studies have demonstrated the efficiency of lung cancer screening (LCS) on mortality rates. However, screening efficiency is related to the targeted population and the participation rate.
In France, the participation rate for breast and colon cancer screening programs is respectively 50% and 32%, which is low. Then, it appears very important to determine which factors are influencing the willingness to participate to these programs. Indeed, it will allow a better communication and we will be able to perform screening campaigns adapted to the eligible population.
The Lyon Hospital is the second university hospital in France. It is composed of 14 buildings and employed 23 000 persons. More than 160 occupations are represented. So, hospital employees look relevant to be studied for LCS program.
ILYAD was divided in 2 parts. The first one was completed in 2020 and goal to evaluate the number of eligible individuals among the hospital employees. About 800 persons would be eligible for LCS.
This second part of the study will evaluate the participation rate and the feasibility of the LCS program. The study will target the 800 individuals that were identified previously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria :
- •Participant have to meet the criteria below:
- •Lyon hospital employee at the day of inclusion:
- •valid hospital employee number,
- •Or retired employee for less than a year before the inclusion
- •AND meeting eligibility criteria as follow :
- •Aged from 50 to 75 yo,
- •AND smoke or have smoked ≥ 10 cigarettes/day during ≥ 30 years OR ≥ 15 cigarettes/day for at least 25 years;
- •AND active smoker or smoking cessation for ≤ 15 years ;
- •Volunteer to start a program of smoking cessation if active smoker;
- •Consent form signed ;
- •Cover by health insurance.
排除标准
- •Participant have to NOT meet the criteria below :
- •Individual not working at Lyon hospital;
- •Individual not payed by the Lyon Hospital but working at it;
- •Individuals not willing to participate;
- •Individual working at René Sabran Hospital;
- •Individual meeting one of this non eligibility for LCS criteria defined by the French recommendation:
- •Not able to climb 2 floors of stairs ;
- •Weight ≥ 140Kg
- •Underwent a chest CT scan less than 1 year ago (except screening scanner);
- •History of lung cancer of less than 5 years or under treatment ; history of any cancer under monitoring by chest scanner ;
- •Comorbidity contraindicating therapeutic options or any kind of invasive interventions ;
- •Ongoing or recent respiratory symptoms that might lead to lung cancer diagnosis (hemoptysia, weight loss, recurrent respiratory infection).
- •Individual who is pregnant or breast feeding;
- •Individual whose mental health is not good enough to participate;
- •Individual in jail or under justice evaluation.
研究组 & 干预措施
Lyon hospital employees with high risk of lung cancer.
Lyon Hospital employees meeting criteria for high risk of lung cancer according French recommendation criteria.
干预措施: Solicitation for lung cancer screening (Behavioral)
Lyon hospital employees with high risk of lung cancer.
Lyon Hospital employees meeting criteria for high risk of lung cancer according French recommendation criteria.
干预措施: added exams to the usual lung cancer screening (Other)
结局指标
主要结局
Participation rate at baseline
时间窗: At the baseline visit
Ratio between the number of participants who underwent a CT scan at baseline and the estimated number of eligible employees
次要结局
- Evaluation of the efficiency of VOC for LC screening(At baseline)
- Identification of predictive factors for participation decision(At baseline and At 1Year follow-up)
- Evaluate the participation rate at 1 year and identify the factors that trigger it.(At 1Year follow-up)
- Participation rate according to the 3 communication levels.(At 4 month = level 1 ; At 8 month = level 2 ; At 12 month = level 3)
- Evaluation of feasibility of the LCS program by measuring the proportion of individuals having undergo all the required exams and evaluations according to the results of the CT scan, conformity of the scan interpretation, and adverse event monitoring.(At baseline and At 1Year follow-up)
- Identification of efficient biomarker for LC screening(At baseline)
- Evaluation of screening efficiency according to the proportion of lung cancer, ILD, COPD diagnosed and the percentage of smoking cessation among the active smokers.(At baseline and At 1Year follow-up)
- Evaluate the follow up to the french guidelines(Follow up after the 1 year visit)