Lung Cancer (Diagnosis)NCT07860359
Impact of Lung Cancer Screening With Chest Scans Combined With Coaching on Smoking Cessation in Heavy Smokers
A study testing Image-Based Counseling, Smoking Cessation Coaching and Low-Dose Chest Computed Tomography (LDCT) in people with Lung Cancer (Diagnosis) and Smoking Cessation, run by Hôpital Fribourgeois at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer (Diagnosis), Smoking Cessation, Lung Neoplasm
- What is being tested?
- Image-Based Counseling, Smoking Cessation Coaching and Low-Dose Chest Computed Tomography (LDCT)
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2027to 31 Dec 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Residence in the canton of Fribourg
- Willingness to quit smoking
- Current smoker: > or = 20 packs years
Who cannot join
- 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
- Pregnancy
- Refusal to be informed of incidental findings of medical importance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Fribourg Cantonal Hospital (HFR)
Fribourg, Canton of Fribourg, 1700
Sandrine Foucras, +41 26 306 21 06, Sandrine.Foucras@h-fr.ch
About this study
Official title: Smoking Termination Outcomes With Pulmonary Low Dose Computed Tomography for Lung Cancer Screening (STOP-LungCancer)
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.
Read more
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:
- Personalized support: 4 smoking cessation coaching sessions organized by CIPRET.
- 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.
- 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.
- Conditions
- Lung Cancer (Diagnosis), Smoking Cessation, Lung Neoplasm
- Being tested
- Image-Based Counseling, Smoking Cessation Coaching, Low-Dose Chest Computed Tomography (LDCT)
- Keywords
- lung cancer, screening, smoking, tobacco, cessation, termination, counselling, coaching, low dose, low-dose, chest, CT, scan, cigarette, LDCT, LCS, early detection, behavioral intervention, cancer, primary prevention
- Medical subject headings
- Lung Neoplasms, Disease, Smoking Cessation, Smoking, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-Based CounselingBehavioural
Face-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 CoachingBehavioural
Also called Smoking Cessation Counselling
Four 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)Radiation
Also called lung cancer screening (LCS)
Low-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).
| Study group | Role | What they receive |
|---|---|---|
| Combined Low-Dose Computed Tomography Screening and Smoking Cessation Coaching | Experimental | Single-arm experimental cohort of heavy smokers undergoing an integrated lung cancer screening and smoking cessation pathway. All enrolled participants receive the combined intervention strategy, which pairs personalized chest computed tomography (CT) imaging results with dedicated specialist counseling and structured behavioral smoking cessation support. This arm aims to evaluate how visual radiological feedback combined with tobacco cessation counseling impacts long-term smoking abstinence rates. Receives: Behavioral: Image-Based Counseling; Behavioral: Smoking Cessation Coaching; Radiation: Low-Dose Chest Computed Tomography (LDCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after the first chest computed tomography (CT)
Secondary outcomes (5)
Smoking Abstinence Rate at 12 Months
Proportion of participants reporting smoking abstinence at the 12-month visit, confirmed by exhaled carbon monoxide (CO) measurement.
Measured: 12 months after the first chest computed tomography
Smoking Abstinence Rate at 24 Months
Proportion of participants reporting smoking abstinence at the 24-month visit, confirmed by exhaled carbon monoxide (CO) measurement.
Measured: 24 months after the first chest computed tomography
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.
Measured: Baseline, 12 months, and 24 months
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.
Measured: Baseline, 12 months, and 24 months
Factors Potentially Influencing Smoking Cessation Success
Exploratory analysis evaluating demographics such as age, sex, place of residence, socioeconomical class, and other factors such as smoking-related lung disease, and cardiac abnormalities. These analyses are exploratory in nature and are intended to generate hypotheses for future studies. No definitive causal inference will be drawn from these analyses.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Fribourgeois
- Sponsor type
- University, hospital or other
- Collaborators
- CIPRET Fribourg (Centre d'information pour la prévention du tabagisme)
- Responsible party
- Principal investigator, Philippe Khafagy, Hôpital Fribourgeois
- Investigators
- Philippe Khafagy, MD, Principal investigator, Hôpital FribourgeoisJon Lutz, MD, Principal investigator, Hôpital Fribourgeois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860359
- Sponsor's protocol ID
- BASEC-2026-01995
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available to protect participant privacy and maintain confidentiality in accordance with Swiss regulatory requirements (Human Research Act and Federal Act on Data Protection). Aggregated data and primary results will be available in peer-reviewed scientific publications.