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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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