FDNYでの禁煙
FDNY における禁煙による肺がんの予防
At the Fire Department of the City of New York (FDNY) World Trade Center Health Program, 36% of participants in the low dose computed tomography (LDCT) lung cancer screening program are current smokers, despite referral to the free FDNY Tobacco Cessation Program (Standard Care). Investigators propose testing an Enhanced Care program which includes opt-out enrollment; tobacco cessation counseling will be individually tailored to spirometry/LDCT results and treatment with varenicline starting 4 weeks prior to their target quit date. This randomized trial will compare enrollment and cessation outcomes in Standard Care vs. Enhanced Care groups of challenging-to-treat, high-risk smokers.
調査の概要
状態
詳細な説明
The overarching goal of this Randomized Controlled trial is to develop and test an effective, scalable intervention with potential to reach high-risk smokers undergoing CT lung cancer screening who have not engaged in or succeeded with traditional tobacco treatment approaches. The investigators will test an Enhanced Care intervention specifically designed to address multiple challenges to tobacco treatment engagement and success. First, the researchers will test opt-out enrollment in cessation treatment. The current tobacco treatment default, in which patients must opt-in to cessation treatment and are only offered counseling and pharmacotherapy when deemed ready to quit, results in missed opportunities to engage smokers into treatment. Previous studies of opt-out enrollment in cessation treatment suggest that an opt-out tobacco treatment strategy substantially increases engagement and cessation rates compared with traditional opt-in approaches. Second, proactive counseling will leverage the "reachable, teachable moment" of CT screening to motivate cessation through individually tailored messaging tied to CT results and lung function spirometry. Using CT results as a motivational tool has shown promise in pilot studies. The optimal approach and success of using CT coupled with spirometry results to motivate tobacco cessation remains unknown. Third, investigators will offer varenicline pre-loading to all enrollees, regardless of study arm, in which varenicline is initiated 4 weeks prior to target quit date. This approach is associated with decreased pre-quit tobacco-associated reward and double the rate of abstinence compared with standard varenicline treatment.
The investigators thus propose a randomized trial among retired FDNY World Trade Center Health Program responders eligible for the FDNY World Trade Center Health Program CT screening program to test the effects of Enhanced Care (opt-out enrollment, tailored counseling based on CT and spirometry results, and varenicline with preloading) against Standard Care (opt-in enrollment, standard cessation counseling without spirometry/CT tailoring, and varenicline with preloading) in the engagement of high-risk smokers in cessation treatment and the achievement of tobacco abstinence.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
New York
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Brooklyn、New York、アメリカ、11201
- FDNY World Trade Center Health Program
-
-
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
説明
Inclusion Criteria
- Enrolled in FDNY World Trade Center Health Program (WTCHP)
- Retired
- Age ≥ 50 years old
- Self-reported current smoker on most recent questionnaire OR self-reported current smoker in the past 5 years
- 20 pack-year smoker OR 20-year smoking duration
Exclusion Criteria
- Reduced renal function
- estimated glomerular filtration rate (eGFR) <30 [CKD-EPI Creatinine Equation (2021)] at last World Trade Center (WTC) medical monitoring blood exam OR ICD10 codes for kidney disease: N04.9, N17.9, N18.9, Z94.0, E13.21, N18.9, I12.9, N00.9, N03.9
- Undergoing active cancer treatment, defined as being diagnosed on 1/1/2022 or later
- Clinical instability (e.g., hospitalization in last 3 months)
- Using varenicline in last 30 days
- Endorsing suicidal ideations: moderate or high risk on Columbia-Suicide Severity Rating Scale (C-SSRS)
- Screened for alcohol use disorder AUDIT>15
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Enhanced Care
Opt-out counseling enrollment. individually-tailored biofeedback linked to Chest CT and spirometry results. Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28. 1 mg twice day for 12 weeks after target quit date. |
Participants automatically enrolled in motivational counseling. Tailored counseling includes sharing results of Chest CT results and lung function spirometry tests with participants. |
|
アクティブコンパレータ：Standard Care
Opt-in counseling enrollment. Standard tobacco cessation counseling. Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28. 1 mg twice day for 12 weeks after target quit date. |
Participants must opt-in to receive counseling. Counseling does not include discussion of Chest CT or spirometry results. |
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 |
|---|---|---|
|
Enrollment
時間枠：Baseline (Week 0)
|
Enrollment is defined as all participants who completed at least one session with our tobacco treatment specialist in FDNY's Tobacco Cessation Program: Standard vs. Enhanced Care arms. The number of participants who attend at least one study visit with the tobacco treatment specialist from the eligible recruitment population will be tabulated and reported. |
Baseline (Week 0)
|
|
Number of Participants With (Biochemically Validated) Tobacco Abstinence
時間枠：Weeks 2, 4, 8, 12, and 16 along with a 12-week post end of treatment (EOT) timepoint visit at 28 weeks
|
7-day point prevalence abstinence will be biochemically verified by the analysis of urine samples collected at a laboratory nearest each participant's residence. Urine sample collection will occur at weeks 2, 4, 8, 12, and 16 along with a 12-week post end of treatment (EOT) timepoint at 28 weeks. Samples will be analyzed for urine cotinine which is the commonly measured biomarker of nicotine intake. Urine cotinine levels < 20 ng/mL will be used to verify tobacco abstinence. Data will be summarized at each timepoint by study arm from weeks 2 - weeks 28 using basic descriptive statistics at each research assessment visit. |
Weeks 2, 4, 8, 12, and 16 along with a 12-week post end of treatment (EOT) timepoint visit at 28 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Retention to Study End-Date
時間枠：Through the 12-week post EOT timepoint at 28 weeks
|
Retention will be assessed and reported as the number of participants retained in the study through the time of the 12-week post end of treatment (EOT) timepoint at 28 weeks. |
Through the 12-week post EOT timepoint at 28 weeks
|
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Number of Participants Who Attended Counseling Visit at Each Timepoint - Counseling Adherence
時間枠：Baseline, Weeks 2, 4, 8, 12, 16, and the 12-week post EOT timepoint visit at 28 weeks
|
Counseling adherence will be determined by the number of counseling visits attended. Tobacco counseling sessions will occur at baseline, and at weeks 2, 4, 8, 12, and 16 along with a 12-week post end of treatment (EOT) timepoint at 28 weeks. Counseling adherence will be summarized by study arm based on attendance during each individual session (timepoint) and reported as a continuous variable for each timepoint (counseling visit). |
Baseline, Weeks 2, 4, 8, 12, 16, and the 12-week post EOT timepoint visit at 28 weeks
|
|
Pill Count Percentage - Varenicline Adherence
時間枠：Baseline, Weeks 2, 4, 8, 12, and 16
|
Varenicline adherence will be measured using pill count percentage, recorded as the number of pills taken divided by the number of pills prescribed, per participant, corresponding to the dosing regimen. Varenicline adherence data will be summarized by study arm using basic descriptive statistics for each week of treatment. Participants refusing medication will be counted as zero. Participants discontinuing medication due to reported side effects or adverse events will be excluded from calculation totals. Medication adherence rates in excess of 100% (e.g., subjects mistakenly took extra pills) will be reported as 100% adherence. Similarly, medication adherence rates below zero (e.g., subjects added pills to the bottle but did not remove any pills) will be reported as 0% adherence. Pill count adherence is an objective measure that has been shown to correlate with electronic monitors and varenicline plasma levels. |
Baseline, Weeks 2, 4, 8, 12, and 16
|
協力者と研究者
協力者
捜査官
- 主任研究者：Shadi Nahvi, MD, MS、Albert Einstein College of Medicine
- 主任研究者：David Goldfarb, PhD、FDNY
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
キーワード
その他の研究ID番号
- 2023-14980
- R21OH012256 (米国 NIH グラント/契約)
- 2023 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The datasets generated and analyzed during the current study are not publicly available, but a deidentified dataset may be available from the principal investigator upon reasonable request.
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
米国で製造され、米国から輸出された製品。
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