Clinical trial NCT05452200: Lung Cancer Screening Implementation Among Employees at Lyon Hospital
Official title: Pilot Study on Lung Cancer Screening Implementation Among Employees at Lyon Hospital
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
screening
tobacco cessation
COPD
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 600
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: * 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.

    * Exclusion Criteria :

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.

Primary outcomes:
measure: Participation rate at baseline
timeFrame: At the baseline visit
Secondary outcomes:
measure: Participation rate according to the 3 communication levels.
timeFrame: At 4 month = level 1 ; At 8 month = level 2 ; At 12 month = level 3
measure: Identification of predictive factors for participation decision
timeFrame: At baseline and At 1Year follow-up
measure: 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.
timeFrame: At baseline and At 1Year follow-up
measure: Evaluation of screening efficiency according to the proportion of lung cancer, ILD, COPD diagnosed and the percentage of smoking cessation among the active smokers.
timeFrame: At baseline and At 1Year follow-up
measure: Evaluate the participation rate at 1 year and identify the factors that trigger it.
timeFrame: At 1Year follow-up
measure: Identification of efficient biomarker for LC screening
timeFrame: At baseline
measure: Evaluation of the efficiency of VOC for LC screening
timeFrame: At baseline
measure: Evaluate the follow up to the french guidelines
timeFrame: Follow up after the 1 year visit
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital L. Pradel
city: Lyon
country: France
facility: Hôpital de la Croix Rousse - Department of Pneumology
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
References: