PLUTO: Program on Lung Cancer Screening and Tobacco Cessation

Sponsor

University of Minnesota (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02597491

Collaborator

(none)

1,000

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking	Behavioral: TLC monthly Behavioral: TLC quarterly Behavioral: MTM Behavioral: 4 week assessment Behavioral: 8 week assessment	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Adaptive Interventions for Smoking Cessation in Lung Cancer Screening Programs

Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

May 1, 2021

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 4 wk assessment + TLC monthly 4 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)	Behavioral: TLC monthly Tobacco longitudinal care monthly Behavioral: 4 week assessment 4 week assessment
Active Comparator: 4 week assessment + TLC quarterly 4 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)	Behavioral: TLC quarterly Tobacco longitudinal care quarterly Behavioral: 4 week assessment 4 week assessment
Active Comparator: 4 week assessment +TLC + MTM 4 week assessment, 4 weeks counseling, NRT, medication management (nonresponders)	Behavioral: TLC monthly Tobacco longitudinal care monthly Behavioral: MTM Medication management therapy Behavioral: 4 week assessment 4 week assessment
Active Comparator: 8 week assessment + TLC monthly 8 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)	Behavioral: TLC monthly Tobacco longitudinal care monthly Behavioral: 8 week assessment 8 week assessment
Active Comparator: 8 week assessment + TLC quarterly 8 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)	Behavioral: TLC quarterly Tobacco longitudinal care quarterly Behavioral: 8 week assessment 8 week assessment
Active Comparator: 8 week assessment + TLC + MTM 8 week assessment, 8 weeks counseling, NRT, medication management (nonresponders)	Behavioral: TLC monthly Tobacco longitudinal care monthly Behavioral: MTM Medication management therapy Behavioral: 8 week assessment 8 week assessment

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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