The main objective is to evaluate the adherence of smoking patients to lung cancer screening by low-dose CT scan, when proposed by the general practitioner.
Lung cancer is the leading cause of cancer mortality in France and worldwide. The KBP2020 study conducted in general hospitals, including 8999 patients diagnosed with lung cancer in the year 2020, showed that 73% of lung cancer cases were diagnosed at an advanced symptomatic stage, explaining the high rate of metastatic status at diagnosis, reaching 58%. For this category of patients, 3-month mortality remains very high, close to 25%. Several large randomized studies have demonstrated that lung cancer screening with low-dose CT scans enables lung cancer to be diagnosed at an early, asymptomatic stage, when it is mostly accessible to curative surgical treatment. This early detection and subsequent treatment reduced specific mortality by 20% in the NLST study, and by up to 39% at 10 years in the MILD study. Overall mortality was reduced by 6.7% in the NLST study. This scientific evidence has led the French National Authority for Health to encourage the implementation of a pilot program, to be organized by the French National Cancer Institute. The hypothesis of the study is that the proposal of CT screening for lung cancer will be better adhered to if it is made by the general practitioner of individuals at risk. Adherence is defined by an initial scan, followed by a second scan one year after the first, with participation in screening on an annual basis. Given the trust that generally characterizes the relationship between patients and their GP, and the fact that intercurrent consultations provide reminders of the need for an annual check-up, the assumption is for an initial participation rate of at least 50%, and a continued participation rate of 70% at 1 year. Communication of results by the GP will help to limit anxiety, particularly in the event of an undetermined result, which will be assessed by the anxiety section of the Hospital Anxiety and Depression scale questionnaire translated into French. In addition, the success of smoking cessation will be compared with literature data in the context of screening. The hypothesis is that the cessation rate will be higher due to the possibility of adapting nicotine substitution by the GP and his or her repeated support in the cessation process. Finally, knowledge of patients' histories will help to limit unnecessary explorations and to better identify for which participants screening reveals COPD (emphysema), osteoporosis or unrecognized coronary artery disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
500
Baseline low dose Ct acquisition, then at 1 year to depict suspicious lung nodules
Hôpital Cochin
Paris, France
RECRUITINGRate of completion of screening scan
Rate of completion of screening scan, one year after initial scan.
Time frame: 12 months
Evolution of tobacco consumption
Comparison of tobacco consumption at 1 year versus consumption at baseline
Time frame: 12 months
Evolution of anxiety
Hospital Anxiety and Depression Scale score (anxiety section) completed by the participant at the initial scan, at 1 year (and any additional scans), at follow-up consultations with the GP (and any additional scans) and at the end of the study. The minimum score is 0 and the maximum is 21. Higher score means worse outcome.
Time frame: 12 months
Chronic obstructive pulmonary disease (COPD)
Number of participants with initially unrecognized COPD confirmed by lung function tests.
Time frame: Up to 12 months
Statin/aspirin prevention
Number of participants for whom statin/aspirin prevention is initiated following initial scan.
Time frame: Up to 12 months.
Osteoporosis
Number of participants with osteoporosis not known at inclusion confirmed by bone densitometry.
Time frame: Up to 12 months.
Other pathologies
Number of other pathologies confirmed by their reference examination.
Time frame: Up to 18 months
Cancer screened
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Rate of stage I cancers among screened cancers.
Time frame: Up to 18 months
Characteristics of eligible population refusing screening : age
Age of eligible people refusing screening
Time frame: Day 0
Characteristics of eligible population refusing screening : sex
Sex of eligible people refusing screening
Time frame: Day 0
Characteristics of eligible population refusing screening : smoking status
Smoking status of eligible people refusing screening
Time frame: Day 0
Characteristics of eligible population refusing screening : level of education
Level of education of eligible people refusing screening
Time frame: Day 0
Characteristics of eligible population refusing screening : reason for refusal
Reason for refusal of eligible people refusing screening
Time frame: Day 0