SmokingPLUTONCT02597491
Program on Lung Cancer Screening and Tobacco Cessation
A study testing TLC monthly, TLC quarterly and MTM in people with Smoking, run by University of Minnesota.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 to 79 years
- Conditions the study is for
- Smoking
- What is being tested?
- TLC monthly, TLC quarterly and MTM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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).
- Conditions
- Smoking
- Being tested
- TLC monthly, TLC quarterly, MTM, 4 week assessment, 8 week assessment
- Keywords
- Smoking,, Smoking cessation, Sequential, multiple assignment, randomized trials (SMART), Lung cancer screening
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC monthlyBehavioural
Tobacco longitudinal care monthly
TLC quarterlyBehavioural
Tobacco longitudinal care quarterly
MTMBehavioural
Medication management therapy
4 week assessmentBehavioural
4 week assessment
8 week assessmentBehavioural
8 week assessment
| Study group | Role | What they receive |
|---|---|---|
| 4 wk assessment + TLC monthly | Active comparator | 4 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders) Receives: Behavioral: TLC monthly; Behavioral: 4 week assessment |
| 4 week assessment + TLC quarterly | Active comparator | 4 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders) Receives: Behavioral: TLC quarterly; Behavioral: 4 week assessment |
| 4 week assessment +TLC + MTM | Active comparator | 4 week assessment, 4 weeks counseling, NRT, medication management (nonresponders) Receives: Behavioral: TLC monthly; Behavioral: MTM; Behavioral: 4 week assessment |
| 8 week assessment + TLC monthly | Active comparator | 8 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders) Receives: Behavioral: TLC monthly; Behavioral: 8 week assessment |
| 8 week assessment + TLC quarterly | Active comparator | 8 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders) Receives: Behavioral: TLC quarterly; Behavioral: 8 week assessment |
| 8 week assessment + TLC + MTM | Active comparator | 8 week assessment, 8 weeks counseling, NRT, medication management (nonresponders) Receives: Behavioral: TLC monthly; Behavioral: MTM; Behavioral: 8 week assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startDec 2015
- Primary completion1 May 2021
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Joseph, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597491
- Sponsor's protocol ID
- 2015NTLS048
- Acronym
- PLUTO
- Status last verified
- Apr 2023
- First submitted
- 28 Oct 2015
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12745503Fu 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.
PubMed 37615989Fu 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.
PubMed 28687349
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Interventions for Smoking Cessation in Lung Cancer Screening Programs
- ClinicalTrials.gov ID
- NCT02597491
- Acronym / sponsor ID
- PLUTO / 2015NTLS048
- Conditions
- Smoking
- Keywords
- Smoking,, Smoking cessation, Sequential, multiple assignment, randomized trials (SMART), Lung cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 4 wk assessment + TLC monthly | Active comparator | Behavioral: TLC monthly, Behavioral: 4 week assessment4 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders) |
| 4 week assessment + TLC quarterly | Active comparator | Behavioral: TLC quarterly, Behavioral: 4 week assessment4 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders) |
| 4 week assessment +TLC + MTM | Active comparator | Behavioral: TLC monthly, Behavioral: MTM, Behavioral: 4 week assessment4 week assessment, 4 weeks counseling, NRT, medication management (nonresponders) |
| 8 week assessment + TLC monthly | Active comparator | Behavioral: TLC monthly, Behavioral: 8 week assessment8 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders) |
| 8 week assessment + TLC quarterly | Active comparator | Behavioral: TLC quarterly, Behavioral: 8 week assessment8 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders) |
| 8 week assessment + TLC + MTM | Active comparator | Behavioral: TLC monthly, Behavioral: MTM, Behavioral: 8 week assessment8 week assessment, 8 weeks counseling, NRT, medication management (nonresponders) |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLC monthlyTobacco longitudinal care monthly | Behavioural | 4 week assessment +TLC + MTM, 4 wk assessment + TLC monthly, 8 week assessment + TLC + MTM, 8 week assessment + TLC monthly |
| TLC quarterlyTobacco longitudinal care quarterly | Behavioural | 4 week assessment + TLC quarterly, 8 week assessment + TLC quarterly |
| MTMMedication management therapy | Behavioural | 4 week assessment +TLC + MTM, 8 week assessment + TLC + MTM |
| 4 week assessment4 week assessment | Behavioural | 4 week assessment + TLC quarterly, 4 week assessment +TLC + MTM, 4 wk assessment + TLC monthly |
| 8 week assessment8 week assessment | Behavioural | 8 week assessment + TLC + MTM, 8 week assessment + TLC monthly, 8 week assessment + TLC quarterly |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 12745503Hughes 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.
- Derived from this study: PubMed 37615989Fu 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.
- Derived from this study: PubMed 28687349Fu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Joseph, MD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing TLC monthly, TLC quarterly and MTM in people with Smoking, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 months prolonged abstinence from smoking, measured 18M after randomization (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02597491, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.