Program on Lung Cancer Screening and Tobacco Cessation

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Behavioral: TLC monthly; Behavioral: TLC quarterly; Behavioral: MTM; Behavioral: 8 week assessment; Behavioral: 4 week assessment

• Registration Number: NCT02597491
• Lead Sponsor: University of Minnesota

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-05
• Study Start: 2015-12
• Primary Completion: 2021-05-01
• Study Completion: 2022-09-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. scheduled or has order for low dose CT screening for lung cancer, or is eligible for screening low-dose CT
2. 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).
3. 55 to 79 years old,
4. Interested in quitting and willing to choose a quit smoking date within the next 12 weeks,
5. voluntary written consent

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Exclusion Criteria

1. 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,
2. No hospitalization for mental health reasons in past 3 months; No thoughts of self-harm in past 2 weeks,
3. 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,
4. 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),
5. No phone
6. Non-English speaking
7. Current diagnosis of lung cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
4 week assessment +TLC + MTM	4 week assessment	4 week assessment, 4 weeks counseling, NRT, medication management (nonresponders)
8 week assessment + TLC monthly	TLC monthly	8 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)
8 week assessment + TLC quarterly	TLC quarterly	8 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)
4 wk assessment + TLC monthly	4 week assessment	4 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)
4 week assessment +TLC + MTM	MTM	4 week assessment, 4 weeks counseling, NRT, medication management (nonresponders)
4 week assessment + TLC quarterly	TLC quarterly	4 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)
4 week assessment +TLC + MTM	TLC monthly	4 week assessment, 4 weeks counseling, NRT, medication management (nonresponders)
8 week assessment + TLC quarterly	8 week assessment	8 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)
8 week assessment + TLC + MTM	TLC monthly	8 week assessment, 8 weeks counseling, NRT, medication management (nonresponders)
4 wk assessment + TLC monthly	TLC monthly	4 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)
4 week assessment + TLC quarterly	4 week assessment	4 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)
8 week assessment + TLC monthly	8 week assessment	8 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)
8 week assessment + TLC + MTM	MTM	8 week assessment, 8 weeks counseling, NRT, medication management (nonresponders)
8 week assessment + TLC + MTM	8 week assessment	8 week assessment, 8 weeks counseling, NRT, medication management (nonresponders)

Primary Outcome Measures

Name	Time	Method
6 months prolonged abstinence from smoking, measured 18M after randomization	18 months	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.