Program on Lung Cancer Screening and Tobacco Cessation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2022-09-30

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.

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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).

Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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4 wk assessment + TLC monthly

4 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)

Group Type ACTIVE_COMPARATOR

TLC monthly

Intervention Type BEHAVIORAL

Tobacco longitudinal care monthly

4 week assessment

Intervention Type BEHAVIORAL

4 week assessment

4 week assessment + TLC quarterly

4 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)

Group Type ACTIVE_COMPARATOR

TLC quarterly

Intervention Type BEHAVIORAL

Tobacco longitudinal care quarterly

4 week assessment

Intervention Type BEHAVIORAL

4 week assessment

4 week assessment +TLC + MTM

4 week assessment, 4 weeks counseling, NRT, medication management (nonresponders)

Group Type ACTIVE_COMPARATOR

TLC monthly

Intervention Type BEHAVIORAL

Tobacco longitudinal care monthly

MTM

Intervention Type BEHAVIORAL

Medication management therapy

4 week assessment

Intervention Type BEHAVIORAL

4 week assessment

8 week assessment + TLC monthly

8 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)

Group Type ACTIVE_COMPARATOR

TLC monthly

Intervention Type BEHAVIORAL

Tobacco longitudinal care monthly

8 week assessment

Intervention Type BEHAVIORAL

8 week assessment

8 week assessment + TLC quarterly

8 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)

Group Type ACTIVE_COMPARATOR

TLC quarterly

Intervention Type BEHAVIORAL

Tobacco longitudinal care quarterly

8 week assessment

Intervention Type BEHAVIORAL

8 week assessment

8 week assessment + TLC + MTM

8 week assessment, 8 weeks counseling, NRT, medication management (nonresponders)

Group Type ACTIVE_COMPARATOR

TLC monthly

Intervention Type BEHAVIORAL

Tobacco longitudinal care monthly

MTM

Intervention Type BEHAVIORAL

Medication management therapy

8 week assessment

Intervention Type BEHAVIORAL

8 week assessment

Interventions

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TLC monthly

Tobacco longitudinal care monthly

Intervention Type BEHAVIORAL

TLC quarterly

Tobacco longitudinal care quarterly

Intervention Type BEHAVIORAL

MTM

Medication management therapy

Intervention Type BEHAVIORAL

4 week assessment

Intervention Type BEHAVIORAL

8 week assessment

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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

Minimum Eligible Age

55 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No