低線量 CT 肺がん検診施設でのタバコ治療の実施
This study is to help determine the most effective type or combination of treatments to offer patients seeking lung cancer screening who are smokers to help them reduce the number of cigarettes they smoke, or quit smoking. The investigators long term goal is to increase the benefits of lung cancer screening by providing a blue print of best practices for screening sites to deliver tobacco treatment to their patients who are smokers, in a way that does not add burden to screening site staff and increases the chances of patients quitting smoking.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
California
-
Los Angeles、California、アメリカ、90033
- University of Southern California (Data Collection Only)
-
Walnut Creek、California、アメリカ、94598
- John Muir Health
-
-
Georgia
-
La Grange、Georgia、アメリカ、30240
- WellStar Health System
-
-
Illinois
-
Chicago、Illinois、アメリカ、606012
- Rush University Medical Center
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Kankakee、Illinois、アメリカ、60901
- Riverside Healthcare
-
-
Indiana
-
Crown Point、Indiana、アメリカ、46307
- St. Mary Medical Center, Community Healthcare System
-
-
Iowa
-
Des Moines、Iowa、アメリカ、50314
- MercyOne Des Moines Medical Center (Data Collection Only)
-
-
Maine
-
Scarborough、Maine、アメリカ、04074
- Maine Medical Center Cancer Institute
-
-
Michigan
-
Detroit、Michigan、アメリカ、48202
- Henry Ford Hospital (Data collection only)
-
Traverse City、Michigan、アメリカ、49684
- Munson Healthcare
-
-
New York
-
Mineola、New York、アメリカ、11501
- NYU Winthrop Hospital
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New York、New York、アメリカ、10065
- Memorial Sloan Kettering Cancer Center
-
New York、New York、アメリカ、10065
- Weill Cornell Medical Center
-
The Bronx、New York、アメリカ、10467
- Montefiore Medical Center (Data Collection Only)
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North Carolina
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Morganton、North Carolina、アメリカ、28655
- Carolinas Healthcare System Blue Ridge
-
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Ohio
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Lancaster、Ohio、アメリカ、43130
- Fairfield Medical Center
-
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Oregon
-
Portland、Oregon、アメリカ、97210
- Legacy Health
-
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Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19140
- Temple University
-
-
参加基準
適格基準
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:
Site Eligibility (as per SC self-report)
& Must be designated as an American College of Radiology (ACR) designated lung cancer screening site
- Reports at least one year of lung cancer screening experience
- Reports conducting at least 20 new initial screenings per month Site Coordinator (SC) Eligibility (as per SC self-report)
- Employed as a full-time Site Coordinator at participating lung cancer screening site Patient Eligibility (as per self-report)
- Between the ages of 50-80 years old
- Seeking baseline or annual follow-up LDCT lung cancer screening
- Have at least a 20 pack-year history of smoking
- Currently a smoker, defined as self-reported cigarette smoking (some days, every day) within the past 30 days.
- Must be reachable by telephone
- Must be English or Spanish speaking due to the study materials being available in only these languages and limited available resources for translation.
Exclusion Criteria:
Patient (as per self-report)
- NRT is medically contraindicated (e.g., recent heart attack within the last 2 weeks or, unstable/worsening angina).
- Smokers who are receiving other tobacco treatment services or have used cessation medications (NRT, bupropion, varenicline) within the past month.
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：防止
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Motivational Interviewing( MI) (Yes vs. No)
Participants will receive two motivational informed cessation sessions; the first delivered face to faceor via telephone by the SC during the patient's initial lung cancer screening visit or during the shared decision making discussion or within about 1 week following their screening visit, and the second session delivered by telephone by the SC approximately 4 to 8 weeks after the first MI session. |
two counseling sessions saliva samples from those reporting abstinence and analyze samples |
|
実験的：Nicotine Replacement Therapy (NRT) Patch (Yes vs. No)
Participants will receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day and written instructions to use the patch daily starting on date they mutually agreed upon with their site coordinator. Participants who smoke fewer than 10 cigarettes per day will receive 4-weeks of the 14mg patch (2 boxes), and 2-weeks of the 7mg patch (1 box). Those who smoke 10 or more cigarettes per day will receive 4-weeks of the 21mg patch (2 boxes) and 2-weeks of the 14mg patch (1 box). Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion & Fulfillment. |
saliva samples from those reporting abstinence and analyze samples receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day |
|
実験的：NRT Lozenge (Yes vs. No)
Participants will receive will receive 6 packs of NRT 2mg lozenge and written instructions to use the lozenge PRN to help manage acute nicotine withdrawal. Participants will be instructed to use the NRT lozenges no more than every 1-2 hours as needed. Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion & Fulfillment. |
saliva samples from those reporting abstinence and analyze samples 6 packs of NRT 2mg lozenge |
|
実験的：Message Framing (Gain vs. Loss)
Overall, a robust body of health communication literature demonstrates that gain-framed messages may be more effective than loss-framed or non-framed (neutral) messages for encouraging smoking cessation. In other words, quitting messages that promote smoking cessation are more persuasive if they emphasize the benefits of quitting (gain-framed) rather than the risks (loss-framed) of persistent smoking (25, 26). Included with the written communication of their LDCT-LCS results, participants will receive a printed individualized quitting message that emphasizes either the benefits of quitting (gain-framed) or the risks of continuing to smoke (loss-framed). |
saliva samples from those reporting abstinence and analyze samples health communication literature and quitting messages |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
number of patients who are tobacco abstinence
時間枠：6 months following study enrollment
|
biochemical verification of smoking abstinence will be conducted Consistent with Intent to Treat, unless self reported smoking abstinence is biochemically verified, (<3 ng/ml for mailed salivary cotinine assay) for participants who fail to return the saliva sample, the cessation outcome will be considered non-abstinent. |
6 months following study enrollment
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Jamie Ostroff, PhD、Memorial Sloan Kettering Cancer Center
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)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 17-500
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。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。