Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

Study Overview
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Brief Summary
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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.

Official Title
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Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Motivational Interviewing (MI)
* Drug: Nicotine Replacement Therapy (NRT)
* Drug: Nicotine Lozenge
* Behavioral: Message Framing
* Other: saliva sample


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The investigators have chosen to conduct a full factorial experimental design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing( MI) (Yes vs. No)<br>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. | Behavioral: Motivational Interviewing (MI)<br>* two counseling sessions<br>Other: saliva sample<br>* saliva samples from those reporting abstinence and analyze samples<br>|
| Experimental: Nicotine Replacement Therapy (NRT) Patch (Yes vs. No)<br>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. | Drug: Nicotine Replacement Therapy (NRT)<br>* receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day<br>Other: saliva sample<br>* saliva samples from those reporting abstinence and analyze samples<br>|
| Experimental: NRT Lozenge (Yes vs. No)<br>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. | Drug: Nicotine Lozenge<br>* 6 packs of NRT 2mg lozenge<br>Other: saliva sample<br>* saliva samples from those reporting abstinence and analyze samples<br>|
| Experimental: Message Framing (Gain vs. Loss)<br>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). | Behavioral: Message Framing<br>* health communication literature and quitting messages<br>Other: saliva sample<br>* saliva samples from those reporting abstinence and analyze samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who are tobacco abstinence | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco Treatment, Lung CT, Cancer Screening, 17-500