- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sandrine Foucras
- Número de teléfono: +41 26 306 21 06
- Correo electrónico: Sandrine.Foucras@h-fr.ch
Ubicaciones de estudio
-
-
Canton of Fribourg
-
Fribourg, Canton of Fribourg, Suiza, 1700
- Fribourg Cantonal Hospital (HFR)
-
Contacto:
- Sandrine Foucras
- Número de teléfono: +41 26 306 21 06
- Correo electrónico: Sandrine.Foucras@h-fr.ch
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
Otros nombres:
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).
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
6-Month Smoking Abstinence Rate
Periodo de tiempo: 6 months after the first chest computed tomography (CT)
|
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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Smoking Abstinence Rate at 12 Months
Periodo de tiempo: 12 months after the first chest computed tomography
|
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
|
|
Smoking Abstinence Rate at 24 Months
Periodo de tiempo: 24 months after the first chest computed tomography
|
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
|
|
Detection Rate of Lung Nodules and Lung Cancer
Periodo de tiempo: Baseline, 12 months, and 24 months
|
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
|
|
Prevalence of Relevant Incidental Findings on Chest Computed Tomography
Periodo de tiempo: Baseline, 12 months, and 24 months
|
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
|
|
Factors Potentially Influencing Smoking Cessation Success
Periodo de tiempo: At baseline
|
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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Philippe Khafagy, MD, Hôpital Fribourgeois
- Investigador principal: Jon Lutz, MD, Hôpital Fribourgeois
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- intervención conductual
- detección temprana
- cáncer de pulmón
- cáncer
- de fumar
- tabaco
- Connecticut
- poner en pantalla
- prevención primaria
- neoplasias pulmonares
- nicotina
- tomografía computarizada
- cesación
- tórax
- escanear
- asesoramiento
- cigarrillo
- entrenamiento
- neoplasia pulmonar
- LDCT
- dosis baja
- dosis baja
- terminación
- LCS
- exhaled carbon monoxide
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Neoplasias por sitio
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Comportamiento de salud
- Neoplasias
- Neoplasias Pulmonares
- Enfermedad
- De fumar
- Dejar de fumar
Otros números de identificación del estudio
- BASEC-2026-01995
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .