- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Sébastien COURAUD, MD
- Telefonnummer: +33 4 78 86 44 01
- E-post: sebastien.couraud@chu-lyon.fr
Studera Kontakt Backup
- Namn: Emmanuel GROLLEAU, MD
- Telefonnummer: +33 4 78 86 44 01
- E-post: emmanuel.grolleau@chu-lyon.fr
Studieorter
-
-
-
Pierre-Bénite, Frankrike, 69310
- Service de Pneumologie Aigue Spécialisée et Cancérologie Thoracique, Hôpital Lyon Sud, Hospices Civils de Lyon
-
Kontakt:
- Sébastien COURAUD, MD
- Telefonnummer: +33 4 78 86 44 01
- E-post: sebastien.couraud@chu-lyon.fr
-
Huvudutredare:
- Sébastien COURAUD, MD
-
Kontakt:
- Emmanuel GROLLEAU, MD
- Telefonnummer: +33 4 78 86 44 01
- E-post: emmanuel.grolleau@chu-lyon.fr
-
Huvudutredare:
- Emmanuel GROLLEAU, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Participants enrolled in the French IMPULSION lung cancer screening pilot program who are active smokers or have stopped smoking within one month before enrollment.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Self-reported Smoking Cessation at 12 Months
Tidsram: 12 months
|
Proportion of participants reporting smoking cessation 12 months after inclusion through the IMPULSION electronic follow-up questionnaire. |
12 months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 69HCL26_1121
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