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Program on Lung Cancer Screening and Tobacco Cessation (PLUTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02597491
Recruitment Status : Active, not recruiting
First Posted : November 5, 2015
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: TLC monthly Behavioral: TLC quarterly Behavioral: MTM Behavioral: 4 week assessment Behavioral: 8 week assessment Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adaptive Interventions for Smoking Cessation in Lung Cancer Screening Programs
Study Start Date : December 2015
Actual Primary Completion Date : May 1, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


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: TLC quarterly
Tobacco longitudinal care quarterly

Behavioral: 4 week assessment
4 week assessment

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: MTM
Medication management therapy

Behavioral: 4 week assessment
4 week assessment

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597491


Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Anne Joseph, MD University of Minnesota
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Statistical Analysis Plan  [PDF] July 29, 2021

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02597491    
Other Study ID Numbers: 2015NTLS048
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: March 2022
Keywords provided by University of Minnesota:
Smoking,
Smoking cessation
Sequential, multiple assignment, randomized trials (SMART)
Lung cancer screening
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases