Program on Lung Cancer Screening and Tobacco Cessation

Study Overview
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Brief Summary
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In this sequential, multiple assignment, randomized trial (SMART) current smokers who are eligible for lung cancer screening will be identified using the electronic medical record at the University of Minnesota and Minneapolis VA (N=1000). All participants will receive 8 weeks of evidence-based first-line smoking cessation treatment. Participants will be eligible for three potential randomizations during one year of smoking intervention: 1) to timing of identifying early response to treatment at 4 vs. 8 weeks (all participants), 2) to telephone-based tobacco longitudinal care (TLC) vs. TLC plus pharmacist-administered Medication Therapy Management (incomplete responders to first-line treatment, Primary Aim), and 3) to monthly TLC contact vs. quarterly TLC contact (complete responders to first-line treatment, Secondary Aim). The primary outcome will be 6 months of prolonged abstinence measured 18 months after the beginning of treatment.

Detailed Description
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In this sequential, multiple assignment, randomized trial (SMART) current smokers who are eligible for lung cancer screening will be identified using the electronic medical record at the University of Minnesota and Minneapolis VA (N=1000). All participants will receive 8 weeks of evidence-based first-line smoking cessation treatment. Participants will be eligible for three potential randomizations during one year of smoking intervention: 1) to timing of identifying early response to treatment at 4 vs. 8 weeks (all participants), 2) to telephone-based tobacco longitudinal care (TLC) vs. TLC plus pharmacist-administered Medication Therapy Management (incomplete responders to first-line treatment, Primary Aim), and 3) to monthly TLC contact vs. quarterly TLC contact (complete responders to first-line treatment, Secondary Aim). The primary outcome will be 6 months of prolonged abstinence measured 18 months after the beginning of treatment (self-reported smoking abstinence using imputation for missing data).

Official Title
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Adaptive Interventions for Smoking Cessation in Lung Cancer Screening Programs

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: TLC monthly
* Behavioral: TLC quarterly
* Behavioral: MTM
* Behavioral: 4 week assessment
* Behavioral: 8 week assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled or has order for low dose CT screening for lung cancer, or is eligible for screening low-dose CT current daily smoker (eligible smokers will have smoked during the past 30 days and on at least 5 out of the past 7 days; individuals who have made a recent quit attempt, for example, in anticipation of their low dose CT scan for lung cancer screening, will be eligible if during the last 30 days, when they were smoking regularly, they smoked on at least 5 out of 7 days of the week). 55 to 79 years old, Interested in quitting and willing to choose a quit smoking date within the next 12 weeks, voluntary written consent Exclusion Criteria: Unstable psychiatric disease, unless stable in treatment for 3 months (smokers on mental health medication with any changes in medication in past 3 months require study MD approval to participate) - Smokers with stable psychiatric disease will be eligible; this baseline characteristic and related symptoms will be considered in analyses, No hospitalization for mental health reasons in past 3 months; No thoughts of self-harm in past 2 weeks, No recent cognitive impairment (difficulties planning or organizing daily activities, such as managing finances, having trouble remembering appointments, or forgetting the correct month of the year); participants reporting recent cognitive impairment will be given the 6-item Callahan Cognitive Screener and must score at least a 5 out of 6 to participate, Participating in a formal quit program (such as tobacco cessation counseling with or without use of NRT, bupropion, or varenicline; Smokers using NRT will be eligible as long as they are not using it as part of a formal quit program), No phone Non-English speaking Current diagnosis of lung cancer

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: 4 wk assessment + TLC monthly<br>4 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders) | Behavioral: TLC monthly<br>* Tobacco longitudinal care monthly<br>Behavioral: 4 week assessment<br>* 4 week assessment<br>|
| Active Comparator: 4 week assessment + TLC quarterly<br>4 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders) | Behavioral: TLC quarterly<br>* Tobacco longitudinal care quarterly<br>Behavioral: 4 week assessment<br>* 4 week assessment<br>|
| Active Comparator: 4 week assessment +TLC + MTM<br>4 week assessment, 4 weeks counseling, NRT, medication management (nonresponders) | Behavioral: TLC monthly<br>* Tobacco longitudinal care monthly<br>Behavioral: MTM<br>* Medication management therapy<br>Behavioral: 4 week assessment<br>* 4 week assessment<br>|
| Active Comparator: 8 week assessment + TLC monthly<br>8 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders) | Behavioral: TLC monthly<br>* Tobacco longitudinal care monthly<br>Behavioral: 8 week assessment<br>* 8 week assessment<br>|
| Active Comparator: 8 week assessment + TLC quarterly<br>8 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders) | Behavioral: TLC quarterly<br>* Tobacco longitudinal care quarterly<br>Behavioral: 8 week assessment<br>* 8 week assessment<br>|
| Active Comparator: 8 week assessment + TLC + MTM<br>8 week assessment, 8 weeks counseling, NRT, medication management (nonresponders) | Behavioral: TLC monthly<br>* Tobacco longitudinal care monthly<br>Behavioral: MTM<br>* Medication management therapy<br>Behavioral: 8 week assessment<br>* 8 week assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 months prolonged abstinence from smoking, measured 18M after randomization | The primary (dichotomous) outcome for all analyses will be whether or not smokers achieve 6-month prolonged abstinence measured at 18 months after the baseline assessment. All analyses will be by intention-to-treat, and include all participants randomized to intervention, regardless of whether they are lost to follow-up. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking,, Smoking cessation, Sequential, multiple assignment, randomized trials (SMART), Lung cancer screening