Program on Lung Cancer Screening and Tobacco Cessation (PLUTO)

• ClinicalTrials.gov Identifier: NCT02597491
• Recruitment Status: Completed
• First Posted: November 5, 2015
• Last Update Posted: April 25, 2023
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

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.

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).

Study Design

• 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
• Actual Study Completion Date: September 30, 2022

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

University of Minnesota

Investigators

• 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

More Information

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. Erratum In: Nicotine Tob Res. 2003 Aug;5(4):603.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT02597491
• Other Study ID Numbers: 2015NTLS048
• First Posted: November 5, 2015
• Last Update Posted: April 25, 2023
• Last Verified: April 2023

Keywords provided by University of Minnesota:

Smoking,; Smoking cessation; Sequential, multiple assignment, randomized trials (SMART); Lung cancer screening

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases