Adaptive Interventions for Smoking Cessation in Lung Cancer Screening Programs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 1,000
- Primary Endpoint
- 6 months prolonged abstinence from smoking, measured 18M after randomization
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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),
- •Non-English speaking
- •Current diagnosis of lung cancer
Arms & Interventions
4 wk assessment + TLC monthly
4 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)
Intervention: TLC monthly (Behavioral)
4 wk assessment + TLC monthly
4 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)
Intervention: 4 week assessment (Behavioral)
4 week assessment + TLC quarterly
4 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)
Intervention: TLC quarterly (Behavioral)
4 week assessment + TLC quarterly
4 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)
Intervention: 4 week assessment (Behavioral)
4 week assessment +TLC + MTM
4 week assessment, 4 weeks counseling, NRT, medication management (nonresponders)
Intervention: TLC monthly (Behavioral)
4 week assessment +TLC + MTM
4 week assessment, 4 weeks counseling, NRT, medication management (nonresponders)
Intervention: MTM (Behavioral)
4 week assessment +TLC + MTM
4 week assessment, 4 weeks counseling, NRT, medication management (nonresponders)
Intervention: 4 week assessment (Behavioral)
8 week assessment + TLC monthly
8 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)
Intervention: TLC monthly (Behavioral)
8 week assessment + TLC monthly
8 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)
Intervention: 8 week assessment (Behavioral)
8 week assessment + TLC quarterly
8 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)
Intervention: TLC quarterly (Behavioral)
8 week assessment + TLC quarterly
8 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)
Intervention: 8 week assessment (Behavioral)
8 week assessment + TLC + MTM
8 week assessment, 8 weeks counseling, NRT, medication management (nonresponders)
Intervention: TLC monthly (Behavioral)
8 week assessment + TLC + MTM
8 week assessment, 8 weeks counseling, NRT, medication management (nonresponders)
Intervention: MTM (Behavioral)
8 week assessment + TLC + MTM
8 week assessment, 8 weeks counseling, NRT, medication management (nonresponders)
Intervention: 8 week assessment (Behavioral)
Outcomes
Primary Outcomes
6 months prolonged abstinence from smoking, measured 18M after randomization
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported