Program on Lung Cancer Screening and Tobacco Cessation
PLUTO
Adaptive Interventions for Smoking Cessation in Lung Cancer Screening Programs
1 other identifier
interventional
1,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2015
CompletedFirst Posted
Study publicly available on registry
November 5, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedApril 25, 2023
April 1, 2023
5.4 years
October 28, 2015
April 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
18 months
Study Arms (6)
4 wk assessment + TLC monthly
ACTIVE COMPARATOR4 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)
4 week assessment + TLC quarterly
ACTIVE COMPARATOR4 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)
4 week assessment +TLC + MTM
ACTIVE COMPARATOR4 week assessment, 4 weeks counseling, NRT, medication management (nonresponders)
8 week assessment + TLC monthly
ACTIVE COMPARATOR8 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders)
8 week assessment + TLC quarterly
ACTIVE COMPARATOR8 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders)
8 week assessment + TLC + MTM
ACTIVE COMPARATOR8 week assessment, 8 weeks counseling, NRT, medication management (nonresponders)
Interventions
Tobacco longitudinal care monthly
Tobacco longitudinal care quarterly
4 week assessment
8 week assessment
Eligibility Criteria
You may qualify if:
- 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).
- to 79 years old,
- Interested in quitting and willing to choose a quit smoking date within the next 12 weeks,
- voluntary written consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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.
PMID: 12745503BACKGROUNDFu SS, Rothman AJ, Vock DM, Lindgren BR, Almirall D, Begnaud A, Melzer AC, Schertz KL, Branson M, Haynes D, Hammett P, Joseph AM. Optimizing Longitudinal Tobacco Cessation Treatment in Lung Cancer Screening: A Sequential, Multiple Assignment, Randomized Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2329903. doi: 10.1001/jamanetworkopen.2023.29903.
PMID: 37615989DERIVEDFu 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.
PMID: 28687349DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Joseph, MD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2015
First Posted
November 5, 2015
Study Start
December 1, 2015
Primary Completion
May 1, 2021
Study Completion
September 30, 2022
Last Updated
April 25, 2023
Record last verified: 2023-04