- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07860359
Impact of Lung Cancer Screening With Chest Scans Combined With Coaching on Smoking Cessation in Heavy Smokers
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.
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sandrine Foucras
- Numéro de téléphone: +41 26 306 21 06
- E-mail: Sandrine.Foucras@h-fr.ch
Lieux d'étude
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Canton of Fribourg
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Fribourg, Canton of Fribourg, Suisse, 1700
- Fribourg Cantonal Hospital (HFR)
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Contact:
- Sandrine Foucras
- Numéro de téléphone: +41 26 306 21 06
- E-mail: Sandrine.Foucras@h-fr.ch
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Residence in the canton of Fribourg
- Willingness to quit smoking
- Current smoker: > or = 20 packs years
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Combined Low-Dose Computed Tomography Screening and Smoking Cessation Coaching
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. |
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". Four structured behavioral counseling sessions delivered by certified tobacco cessation experts of the Center for Tobacco Prevention (CIPRET), personalized to support long-term abstinence.
Autres noms:
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).
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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6-Month Smoking Abstinence Rate
Délai: 6 months after the first chest computed tomography (CT)
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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. |
6 months after the first chest computed tomography (CT)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Smoking Abstinence Rate at 12 Months
Délai: 12 months after the first chest computed tomography
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Proportion of participants reporting smoking abstinence at the 12-month visit, confirmed by exhaled carbon monoxide (CO) measurement. |
12 months after the first chest computed tomography
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Smoking Abstinence Rate at 24 Months
Délai: 24 months after the first chest computed tomography
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Proportion of participants reporting smoking abstinence at the 24-month visit, confirmed by exhaled carbon monoxide (CO) measurement. |
24 months after the first chest computed tomography
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Detection Rate of Lung Nodules and Lung Cancer
Délai: Baseline, 12 months, and 24 months
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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. |
Baseline, 12 months, and 24 months
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Prevalence of Relevant Incidental Findings on Chest Computed Tomography
Délai: Baseline, 12 months, and 24 months
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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. |
Baseline, 12 months, and 24 months
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Factors Potentially Influencing Smoking Cessation Success
Délai: At baseline
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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. |
At baseline
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Philippe Khafagy, MD, Hôpital Fribourgeois
- Chercheur principal: Jon Lutz, MD, Hôpital Fribourgeois
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- intervention comportementale
- la détection précoce
- cancer du poumon
- cancer
- fumeur
- le tabac
- TDM
- dépistage
- prévention primaire
- tumeurs pulmonaires
- nicotine
- tomodensitométrie
- cessation
- poitrine
- analyse
- conseils
- cigarette
- encadrement
- tumeur pulmonaire
- TPMD
- petite dose
- petite dose
- Résiliation
- LCS
- exhaled carbon monoxide
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BASEC-2026-01995
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
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