Lung Cancer Screening Implementation Among Employees at Lyon Hospital

NCT05452200 | Unknown

• 1 other identifier: 69HCL22_0466
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

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

Keywords

lung cancer; screening; tobacco cessation; COPD

Outcome Measures

Primary Outcomes (1)

• Participation rate at baseline

  Ratio between the number of participants who underwent a CT scan at baseline and the estimated number of eligible employees

  At the baseline visit

Secondary Outcomes (8)

• Participation rate according to the 3 communication levels.

  At 4 month = level 1 ; At 8 month = level 2 ; At 12 month = level 3

• Identification of predictive factors for participation decision

  At baseline and At 1Year follow-up

• 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

• 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 participation rate at 1 year and identify the factors that trigger it.

  At 1Year follow-up

Study Arms (1)

Lyon hospital employees with high risk of lung cancer.

EXPERIMENTAL

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

Behavioral: Solicitation for lung cancer screening; Other: added exams to the usual lung cancer screening

Interventions

Solicitation for lung cancer screening 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

Lyon hospital employees with high risk of lung cancer.

added exams to the usual lung cancer screening OTHER

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

Lyon hospital employees with high risk of lung cancer.

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant have to meet the criteria below:
• valid hospital employee number,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Hôpital L. Pradel

Bron, France

RECRUITING

Hôpital de la Croix Rousse - Department of Pneumology

Lyon, France

RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Tobacco Use Cessation; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Health Behavior; Behavior; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sébastien COURAUD, Pr

CONTACT

04.78.86.44.01; sebastien.couraud@chu-lyon.fr

Julie DE BERMONT

CONTACT

+33 0478866698; Julie.de-bermont@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 11, 2022
• Study Start: September 21, 2022
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)