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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Sébastien COURAUD, MD
- 電話番号:+33 4 78 86 44 01
- メール:sebastien.couraud@chu-lyon.fr
研究連絡先のバックアップ
- 名前:Emmanuel GROLLEAU, MD
- 電話番号:+33 4 78 86 44 01
- メール:emmanuel.grolleau@chu-lyon.fr
研究場所
-
-
-
Pierre-Bénite、フランス、69310
- Service de Pneumologie Aigue Spécialisée et Cancérologie Thoracique, Hôpital Lyon Sud, Hospices Civils de Lyon
-
コンタクト:
- Sébastien COURAUD, MD
- 電話番号:+33 4 78 86 44 01
- メール:sebastien.couraud@chu-lyon.fr
-
主任研究者:
- Sébastien COURAUD, MD
-
コンタクト:
- Emmanuel GROLLEAU, MD
- 電話番号:+33 4 78 86 44 01
- メール:emmanuel.grolleau@chu-lyon.fr
-
主任研究者:
- Emmanuel GROLLEAU, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Participants enrolled in the French IMPULSION lung cancer screening pilot program who are active smokers or have stopped smoking within one month before enrollment.
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:CASE_CONTROL
- 時間の展望:PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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 |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-reported Smoking Cessation at 12 Months
時間枠:12 months
|
Proportion of participants reporting smoking cessation 12 months after inclusion through the IMPULSION electronic follow-up questionnaire. |
12 months
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 69HCL26_1121
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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