Program on Lung Cancer Screening and Tobacco Cessation (PLUTO)

April 24, 2023 updated by: University of Minnesota

Adaptive Interventions for Smoking Cessation in Lung Cancer Screening Programs

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: 4 week assessment
4 week assessment
Behavioral: TLC quarterly
Tobacco longitudinal care quarterly
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: 4 week assessment
4 week assessment
Behavioral: MTM
Medication management therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Anne Joseph, MD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015NTLS048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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