- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07921719
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program (PROMETHEE)
Evaluation of an Intensive Tele-Tobacco Cessation Program Compared With Standard Smoking Cessation Support in Participants of the French IMPULSION Lung Cancer Screening Program (PROMETHEE)
This prospective observational study aims to evaluate whether an intensive tele-tobacco cessation program delivered through the PROMETHEE platform improves smoking cessation among smokers participating in the French national lung cancer screening pilot program IMPULSION. Participants receiving the PROMETHEE pathway will be compared with matched controls receiving standard smoking cessation support available through IMPULSION. The primary endpoint is self-reported smoking cessation at 12 months.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lung cancer remains the leading cause of cancer-related mortality in France. Smoking cessation is a key component of lung cancer screening programs. The French national pilot screening program IMPULSION systematically proposes smoking cessation support to smokers; however, access to tobacco treatment services is heterogeneous across regions.
PROMETHEE was developed to provide a shared tele-tobacco cessation platform accessible to participating IMPULSION centers. The intervention relies on specialized tobacco-treatment nurses, facilitated access to teleconsultations, structured follow-up, and systematic prescription of evidence-based smoking cessation therapies, including nicotine replacement therapy or varenicline when appropriate.
The study is a prospective, non-randomized, nested case-control cohort study. Participants receiving care through PROMETHEE will be compared with matched controls selected from the IMPULSION database using a 2:1 matching ratio based on age and sex. No additional study-specific procedures or data collection are required beyond routine care and the existing IMPULSION information system.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sébastien COURAUD, MD
- Phone Number: +33 4 78 86 44 01
- Email: sebastien.couraud@chu-lyon.fr
Study Contact Backup
- Name: Emmanuel GROLLEAU, MD
- Phone Number: +33 4 78 86 44 01
- Email: emmanuel.grolleau@chu-lyon.fr
Study Locations
-
-
-
Pierre-Bénite, France, 69310
- Service de Pneumologie Aigue Spécialisée et Cancérologie Thoracique, Hôpital Lyon Sud, Hospices Civils de Lyon
-
Contact:
- Sébastien COURAUD, MD
- Phone Number: +33 4 78 86 44 01
- Email: sebastien.couraud@chu-lyon.fr
-
Principal Investigator:
- Sébastien COURAUD, MD
-
Contact:
- Emmanuel GROLLEAU, MD
- Phone Number: +33 4 78 86 44 01
- Email: emmanuel.grolleau@chu-lyon.fr
-
Principal Investigator:
- Emmanuel GROLLEAU, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Participants enrolled in the French IMPULSION lung cancer screening pilot program who are active smokers or have stopped smoking within one month before enrollment.
Description
Inclusion Criteria:
PROMETHEE Group:
- Enrolled in IMPULSION
- Active smoker or smoking cessation within the previous month
- Referred to PROMETHEE by an IMPULSION investigator
Control Group:
- Enrolled in IMPULSION
- Active smoker or smoking cessation within the previous month
- Not referred to PROMETHEE
- Selected from the IMPULSION database
- Matched by age (±5 years) and sex
Exclusion Criteria:
- Control subjects already included in PROMETHEE
- Any exclusion criterion applicable under the IMPULSION program itself
Study Plan
How is the study designed?
Design Details
- Observational Models: CASE_CONTROL
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
PROMETHEE Cohort
Participants enrolled in IMPULSION and referred to the PROMETHEE tele-tobacco platform. The pathway includes facilitated access to smoking cessation specialists, up to four follow-up teleconsultations, and systematic consideration of pharmacological cessation treatment. |
PROMETHEE tele-tobacco platform |
|
Control Cohort
Matched IMPULSION participants receiving standard smoking cessation support according to local resources and the routine IMPULSION program |
Routine IMPULSION Cohorte |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported Smoking Cessation at 12 Months
Time Frame: 12 months
|
Proportion of participants reporting smoking cessation 12 months after inclusion through the IMPULSION electronic follow-up questionnaire. |
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL26_1121
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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