Tobacco Treatment in the Context of Lung Cancer Screening

Study Overview
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Brief Summary
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The proposed study will test a medication plus text messaging intervention specifically designed for lung cancer screening patients. Half of the patients will receive standard of care, and half will receive the treatment intervention.

Detailed Description
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Screening for lung cancer at earlier, more treatable stages has the potential to reduce mortality from the U.S.'s most deadly cancer. Annual lung cancer screening with low-dose computed tomography is now recommended for high risk individuals based on age and smoking history. This study will evaluate a smoking cessation intervention for lung cancer screening patients. We will evaluate quit rates after a standard intervention (brief counseling session at time of lung cancer screening) versus a dual nicotine replacement therapy (NRT) and gain-framed text messaging intervention.

Official Title
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Tobacco Treatment in the Context of Lung Cancer Screening

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Text messaging plus nicotine replacement therapy
* Other: Standard Care at Lung Cancer Screening


Participation Criteria
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Eligibility Criteria
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Inclusion: 55 years or older 30 pack year history of smoking current smoker (defined as breath carbon monoxide>6ppm) willing to be randomized English speaking Exclusion: unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, substance abuse, or dementia in the immediate (within 2 weeks) post myocardial infarction period serious arrhythmias unstable angina pectoris hemodynamically or electrically unstable currently taking part in any other tobacco treatment program or using cessation medication (i.e., taking NRT or other cessation medications, enrolled in the Quitline, in another drug study).

Ages Eligible for Study
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Minimum Age: 55 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Advice to quit and brief discussion of tobacco use plus dual nicotine replacement therapy plus 8 weeks of gain-framed text messages tailored to lung cancer screening patients | Behavioral: Text messaging plus nicotine replacement therapy<br>* Brief advice to quit smoking prior to lung cancer screening (LCS), 8 weeks of gain-framed, LCS-tailored text messages, and nicotine replacement therapy.<br>|
| Active Comparator: Standard Care<br>Advice to quit and brief discussion of tobacco use | Other: Standard Care at Lung Cancer Screening<br>* Brief advice to quit smoking prior to lung cancer screening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of Treatment Abstinence Rates | 7-day point prevalence abstinence rates | Week 8 (end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of Study Abstinence Rates | Effect size estimates at End of Study | 3-month follow-up |