Smoking CessationPROMETHEENCT07921719
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
An observational study of Smoking Cessation and Lung Cancer Screening, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Smoking Cessation, Lung Cancer Screening
- What is being tested?
- PROMETHEE Cohort
- How many people
- 5,400 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2027to Jan 2030
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 74 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Control subjects already included in PROMETHEE
- Any exclusion criterion applicable under the IMPULSION program itself
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service de Pneumologie Aigue Spécialisée et Cancérologie Thoracique, Hôpital Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69310
Emmanuel GROLLEAU, MD, 4 78 86 44 01 ext. +33, emmanuel.grolleau@chu-lyon.fr
Sébastien COURAUD, MD, 4 78 86 44 01 ext. +33, sebastien.couraud@chu-lyon.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation, Lung Cancer Screening
- Being tested
- PROMETHEE Cohort, Control Cohort
- Keywords
- Smoking Cessation, Program IMPULSION, Tele-tobacco cessation platform PROMETHEE
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMETHEE CohortOther
PROMETHEE tele-tobacco platform
Control CohortOther
Routine IMPULSION Cohorte
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PROMETHEE Cohort | |
| Control Cohort | Matched IMPULSION participants receiving standard smoking cessation support according to local resources and the routine IMPULSION program Receives: Other: Control Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Smoking Cessation at 12 Months
Proportion of participants reporting smoking cessation 12 months after inclusion through the IMPULSION electronic follow-up questionnaire.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5,400 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921719
- Sponsor's protocol ID
- 69HCL26_1121
- Acronym
- PROMETHEE
- Status last verified
- Nov 2026
- First submitted
- 27 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07921719
- Acronym / sponsor ID
- PROMETHEE / 69HCL26_1121
- Conditions
- Smoking Cessation, Lung Cancer Screening
- Keywords
- Smoking Cessation, Program IMPULSION, Tele-tobacco cessation platform PROMETHEE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,400 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROMETHEE Cohort | – | Other: PROMETHEE CohortParticipants 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. |
| Control Cohort | – | Other: Control CohortMatched IMPULSION participants receiving standard smoking cessation support according to local resources and the routine IMPULSION program |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Enrolled in IMPULSION
- Active smoker or smoking cessation within the previous month
- Referred to PROMETHEE by an IMPULSION investigator
- Enrolled in IMPULSION
- Active smoker or smoking cessation within the previous month
Key exclusion criteria (2 listed)
- Control subjects already included in PROMETHEE
- Any exclusion criterion applicable under the IMPULSION program itself
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROMETHEE CohortPROMETHEE tele-tobacco platform | Other | PROMETHEE Cohort |
| Control CohortRoutine IMPULSION Cohorte | Other | Control Cohort |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation and Lung Cancer Screening, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel GROLLEAU, MD (4 78 86 44 01 ext. +33, emmanuel.grolleau@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Smoking Cessation at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.