About this trial
Lung cancer is common and serious, but when detected early, the chances of recovery are significantly better. Tobacco use is the leading cause. To help people break free from smoking, the Fribourg Cantonal Hospital (HFR), the Center for Tobacco Prevention (CIPRET), and the Fribourg Cancer League are joining forces in the STOP-LungCancer study (Smoking Termination Outcomes with Pulmonary Low Dose Computed Tomography for Lung Cancer Screening).
What is the goal of this study? The investigators want to determine whether seeing and understanding images of the participants' own lungs helps participants quit smoking for good. Smoking cessation will be verified at 6 months using a breath test (measuring carbon monoxide), followed by a 2-year follow-up.
How does participation work? The study is open to 116 residents of the canton of Fribourg aged 50 to 79 who are heavy smokers and motivated to quit.
The program includes:
1. Personalized support: 4 smoking cessation coaching sessions organized by CIPRET. 2. Lung computed tomography (CT) scans: 3 exams spaced one year apart. This scan involves no needles or injections. The radiation dose is very low, about 0.6 millisieverts (mSv) per scan, and the associated risk is considered very low. 3. A review of the images with a doctor: During dedicated consultations, a thoracic radiologist reviews the participant's own computed tomography (CT) scans with the participant to explain the condition of the lungs and heart.
What are the benefits? Participants receive both tailored support to quit smoking and close monitoring to detect any potential issues at a very early stage.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Residence in the canton of Fribourg
Willingness to quit smoking
Current smoker: > or = 20 packs years
Disqualifiers
Previous diagnosis of cancer
Major medical problems (Eastern Cooperative Oncology Group, ECOG ≥ 2)
Chest computed tomography (CT) scan in the last 12 months
Hemoptysis or unintentional weight loss > 7 kilograms (kg) in the last year
Trial design
Single group
Treatments tested in this trial
Image-Based Counseling
BehavioralFace-to-face physician consultations where a thoracic radiologist reviews the participant's own computed tomography (CT) scans with the participant to explain lung and cardiovascular health, creating a visual "teachable moment".
Smoking Cessation Coaching
BehavioralFour structured behavioral counseling sessions delivered by certified tobacco cessation experts of the Center for Tobacco Prevention (CIPRET), personalized to support long-term abstinence.
Low-Dose Chest Computed Tomography (LDCT)
RadiationLow-dose chest computed tomography (LDCT) scans without intravenous contrast at baseline, 12 months, and 24 months, and additional follow-up LDCT when indicated by the screening result (Lung Computed Tomography Screening Reporting and Data System \[Lung-RADS\] category 3).
Treatment groups
Trial outcomes
Primary outcomes
6-Month Smoking Abstinence Rate
Proportion of participants who achieve smoking abstinence at 6 months after the first chest computed tomography (CT). Abstinence is self-reported and objectively validated using exhaled carbon monoxide (CO) measurement.
Secondary outcomes
Smoking Abstinence Rate at 12 Months
Proportion of participants reporting smoking abstinence at the 12-month visit, confirmed by exhaled carbon monoxide (CO) measurement.
Smoking Abstinence Rate at 24 Months
Proportion of participants reporting smoking abstinence at the 24-month visit, confirmed by exhaled carbon monoxide (CO) measurement.
Detection Rate of Lung Nodules and Lung Cancer
Proportion of participants with positive low-dose computed tomography (LDCT) findings requiring further diagnostic follow-up or tissue biopsy, categorized according to the standardized Lung Computed Tomography Screening Reporting and Data System (Lung-RADS) assessment categories.
Prevalence of Relevant Incidental Findings on Chest Computed Tomography
Proportion of relevant non-lung-nodule incidental findings detected on low-dose chest computed tomography, such as smoking-related lung disease, cardiac abnormalities and other findings unrelated to smoking.
Sponsors and contacts
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Hôpital Cantonal de Fribourg
Lead sponsor
CIPRET Fribourg (Centre d'information pour la prévention du tabagisme)
Collaborator
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