Program on Lung Cancer Screening and Tobacco Cessation (PLUTO)

University of Minnesota (UMN)

Status: Completed

Conditions: Smoking

Treatments: Behavioral: 8 week assessment; Behavioral: TLC monthly; Behavioral: MTM; Behavioral: TLC quarterly; Behavioral: 4 week assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT02597491

2015NTLS048

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,000 estimated patients

Sex: All

Ages: 55 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,000 participants in 6 patient groups

4 wk assessment + TLC monthly

Active Comparator group

Description:

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

Treatment:

Behavioral: TLC monthly

Behavioral: 4 week assessment

4 week assessment + TLC quarterly

Active Comparator group

Description:

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

Treatment:

Behavioral: 4 week assessment

Behavioral: TLC quarterly

4 week assessment +TLC + MTM

Active Comparator group

Description:

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

Treatment:

Behavioral: TLC monthly

Behavioral: 4 week assessment

Behavioral: MTM

8 week assessment + TLC monthly

Active Comparator group

Description:

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

Treatment:

Behavioral: TLC monthly

Behavioral: 8 week assessment

8 week assessment + TLC quarterly

Active Comparator group

Description:

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

Treatment:

Behavioral: TLC quarterly

Behavioral: 8 week assessment

8 week assessment + TLC + MTM

Active Comparator group

Description:

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

Treatment:

Behavioral: TLC monthly

Behavioral: MTM

Behavioral: 8 week assessment