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Program on Lung Cancer Screening and Tobacco Cessation (PLUTO)

Primary Purpose

Smoking

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TLC monthly
TLC quarterly
MTM
4 week assessment
8 week assessment
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking focused on measuring Smoking,, Smoking cessation, Sequential, multiple assignment, randomized trials (SMART), Lung cancer screening

Eligibility Criteria

55 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    4 wk assessment + TLC monthly

    4 week assessment + TLC quarterly

    4 week assessment +TLC + MTM

    8 week assessment + TLC monthly

    8 week assessment + TLC quarterly

    8 week assessment + TLC + MTM

    Arm Description

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

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

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

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

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

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

    Outcomes

    Primary Outcome Measures

    6 months prolonged abstinence from smoking, measured 18M after randomization
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 28, 2015
    Last Updated
    April 24, 2023
    Sponsor
    University of Minnesota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02597491
    Brief Title
    Program on Lung Cancer Screening and Tobacco Cessation
    Acronym
    PLUTO
    Official Title
    Adaptive Interventions for Smoking Cessation in Lung Cancer Screening Programs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    May 1, 2021 (Actual)
    Study Completion Date
    September 30, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Minnesota

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Smoking
    Keywords
    Smoking,, Smoking cessation, Sequential, multiple assignment, randomized trials (SMART), Lung cancer screening

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    4 wk assessment + TLC monthly
    Arm Type
    Active Comparator
    Arm Description
    4 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)
    Arm Title
    4 week assessment + TLC quarterly
    Arm Type
    Active Comparator
    Arm Description
    4 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)
    Arm Title
    4 week assessment +TLC + MTM
    Arm Type
    Active Comparator
    Arm Description
    4 week assessment, 4 weeks counseling, NRT, medication management (nonresponders)
    Arm Title
    8 week assessment + TLC monthly
    Arm Type
    Active Comparator
    Arm Description
    8 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)
    Arm Title
    8 week assessment + TLC quarterly
    Arm Type
    Active Comparator
    Arm Description
    8 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)
    Arm Title
    8 week assessment + TLC + MTM
    Arm Type
    Active Comparator
    Arm Description
    8 week assessment, 8 weeks counseling, NRT, medication management (nonresponders)
    Intervention Type
    Behavioral
    Intervention Name(s)
    TLC monthly
    Intervention Description
    Tobacco longitudinal care monthly
    Intervention Type
    Behavioral
    Intervention Name(s)
    TLC quarterly
    Intervention Description
    Tobacco longitudinal care quarterly
    Intervention Type
    Behavioral
    Intervention Name(s)
    MTM
    Intervention Description
    Medication management therapy
    Intervention Type
    Behavioral
    Intervention Name(s)
    4 week assessment
    Intervention Description
    4 week assessment
    Intervention Type
    Behavioral
    Intervention Name(s)
    8 week assessment
    Intervention Description
    8 week assessment
    Primary Outcome Measure Information:
    Title
    6 months prolonged abstinence from smoking, measured 18M after randomization
    Description
    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.
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anne Joseph, MD
    Organizational Affiliation
    University of Minnesota
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12745503
    Citation
    Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003 Feb;5(1):13-25. Erratum In: Nicotine Tob Res. 2003 Aug;5(4):603.
    Results Reference
    background
    PubMed Identifier
    28687349
    Citation
    Fu SS, Rothman AJ, Vock DM, Lindgren B, Almirall D, Begnaud A, Melzer A, Schertz K, Glaeser S, Hammett P, Joseph AM. Program for lung cancer screening and tobacco cessation: Study protocol of a sequential, multiple assignment, randomized trial. Contemp Clin Trials. 2017 Sep;60:86-95. doi: 10.1016/j.cct.2017.07.002. Epub 2017 Jul 4. No abstract available.
    Results Reference
    derived

    Learn more about this trial

    Program on Lung Cancer Screening and Tobacco Cessation

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