Lung Cancer Screening Implementation Among Employees at Lyon Hospital

NCT ID: NCT05452200

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2024-09-12

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Lyon hospital employees with high risk of lung cancer.

Lyon Hospital employees meeting criteria for high risk of lung cancer according French recommendation criteria.

Group Type: EXPERIMENTAL

Solicitation for lung cancer screening

Intervention Type: BEHAVIORAL

3 levels of solicitation will be cumulated. First : a Simple collective solicitation of all staff via internal media 4 months later : Personalized indirect solicitation of at-risk groups with information posted in identified areas 4 months later : Personalized direct solicitation of at-risk groups

added exams to the usual lung cancer screening

Intervention Type: OTHER

• spirometry examination
• Questionnaires
• Blood samples and breath samples to find biomarkers

Interventions

Solicitation for lung cancer screening

3 levels of solicitation will be cumulated. First : a Simple collective solicitation of all staff via internal media 4 months later : Personalized indirect solicitation of at-risk groups with information posted in identified areas 4 months later : Personalized direct solicitation of at-risk groups

Intervention Type: BEHAVIORAL

added exams to the usual lung cancer screening

• spirometry examination
• Questionnaires
• Blood samples and breath samples to find biomarkers

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital L. Pradel

Bron, , France

Site Status: RECRUITING

Hôpital de la Croix Rousse - Department of Pneumology

Lyon, , France

Site Status: RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sébastien COURAUD, Pr

Role: CONTACT

sebastien.couraud@chu-lyon.fr

04.78.86.44.01

Julie DE BERMONT

Role: CONTACT

Julie.de-bermont@chu-lyon.fr

+33 0478866698

Facility Contacts

Michael DURUISSEAUX, MD

Role: primary

Lize KIAKOUAMA-MALEKA, MD

Role: primary

lize.kiakouama-maleka@chu-lyon.fr

0426109237 ext. +33

Sébastien COURAUD, PhD

Role: primary

sebastien.couraud@chu-lyon.fr

0478863718 ext. +33

Other Identifiers

69HCL22_0466

Identifier Type: -

Identifier Source: org_study_id