Gain-framed Messages and NRT for Lung Cancer Screening Patients

Study Overview
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Brief Summary
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This research is a randomized smoking cessation trial conducted within and specifically personalized for lung cancer screening patients presenting to a lung screening clinic. Novel tobacco treatments for this population are critically needed, given the growing population of lung screening patients, which will grow dramatically now that lung screening is an approved CMS benefit. In the proposed study, we will test a gain-framed messaging intervention specifically designed for lung screening patients (vs. unframed messaging), as well as evaluating NRT sampling (vs. no medication) at 2 study sites. Our project is designed to be translational (in that it can be transferable from our controlled efficacy study to other lung screening programs).

Official Title
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Gain-framed Messages and NRT Sampling to Promote Smoking Cessation in Lung Cancer Screening Programs

Conditions
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Lung Cancer Screening, Smoking Cessation

Intervention / Treatment
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* Combination Product: Gain-framed messaging plus NRT
* Behavioral: Unframed messaging materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 years or older at least a 20-pack year history of smoking current smoker (defined as any smoking in the past 30 days) willing to be randomized English speaking Exclusion Criteria: unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia, known allergy to adhesives being in the immediate (within 2 weeks) post myocardial infarction period serious arrhythmias unstable angina pectoris hemodynamically or electrically unstable. current participation in another tobacco treatment program (e.g., using medication from a primary care doctor, Quitline, etc.)

Ages Eligible for Study
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Minimum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No NRT - Unframed Messaging<br>Unframed smoking cessation materials, but no NRT and no gain-framed messaging. | Behavioral: Unframed messaging materials<br>* Unframed smoking cessation materials<br>|
| Experimental: NRT plus Gain-framed Messaging<br>Gain-framed messaging plus NRT. | Combination Product: Gain-framed messaging plus NRT<br>* Gain-framed messaging materials and NRT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation rates | NRT+Gain-framed messaging vs. No NRT+Unframed messaging | 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation rates | Gain-framed messaging + NRT & Unframed messaging + NRT vs. Gain-framed messaging + No NRT & Unframed messaging + No NRT | 6 month follow-up | 
| Smoking cessation rates | Gain-framed messaging + NRT & Gain-framed messaging + No NRT vs. Unframed messaging + NRT & Unframed messaging + No NRT | 6 month follow-up | 
| Smoking cessation rates | Gain-framed messaging + NRT & Gain-framed messaging + No NRT & Unframed messaging + NRT vs. Unframed messaging + No NRT | 6 month follow-up |