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The Lung Screening, Tobacco and Health Project

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200236
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : January 22, 2020
Sponsor:
Collaborators:
Hackensack Meridian Health
Baptist Health South Florida
Lahey Hospital & Medical Center
University of Michigan
National Cancer Institute (NCI)
Unity Point Health
MedStar Shah Medical Group
Anne Arundel Medical Center
Information provided by (Responsible Party):
Georgetown University

Brief Summary:
The purpose of this study is to compare intensive telephone counseling (ITC) plus the nicotine patch vs. standard telephone counseling plus the nicotine patch (Usual Care; UC) among current smokers undergoing lung cancer screening. Smoking-related outcomes will be examined at three, six and twelve months post-randomization.

Condition or disease Intervention/treatment Phase
Smoking, Tobacco Tobacco-Related Carcinoma Tobacco Use Lung Cancer Screening Behavioral: Intensive Telephone Counseling (8 sessions) with nicotine replacement Behavioral: Usual Care: Telephone counseling (3 sessions) with nicotine replacement Phase 3

Detailed Description:

The investigators have built on the evidence-base of telephone counseling for smoking cessation. This pragmatic approach is designed at the intersection of scalability and intensity, for future implementation within the national tobacco quitline. In collaboration with five geographically and ethnically diverse lung cancer screening programs, the investigators will accrue smokers who have registered for screening,and are at all levels of readiness to quit. Prior to the screening day, the investigators will conduct the baseline (T0) phone interview. Following participants' receipt of their screening result (one week post-screening), the investigators will complete the T1 phone interview, provide brief advice to quit and conduct randomization. Participants will be randomized into one of two groups: ITC, in which participants are provided up to 8 counseling sessions lasting approximately 20 minutes each and access to 8-weeks of free nicotine patches. ITC will include a discussion of screening results throughout counseling sessions. The UC arm will include up to 3 counseling sessions lasting approximately 20 minutes each and access to 2-weeks of free nicotine patches. UC will not include a discussion of screening results throughout counseling sessions. All sessions will be conducted by a Tobacco Treatment Specialist (English or Spanish) and the investigators will assess intervention fidelity. In both groups, the investigators will engage referring physicians by notifying them of their patients' study enrollment and of their patients' smoking status at the 6-month follow-up. The 3-month (T2), 6-month (T3), and 12-month (T4) assessments will assess readiness to quit, quit attempts, 7-day and 30-day abstinence verified by Nicalert or carbon monoxide testing, and intervention process variables. Furthermore, two important aspects of this approach include a cost-effectiveness analysis and use of the Cancer Intervention and Surveillance Modeling Network (CISNET) to evaluate the cost of the interventions relative to their impact on short- and long-term smoking-related outcomes.

The aims are:

  1. To compare ITC vs. UC standard telephone counseling. H1.1. At 3-, 6-, and 12- months, the ITC arm will have significantly improved biochemically verified 7-day and 30-day abstinence, compared to UC. H1.2. Mediators, including teachable moment factors (e.g., perceived risk based on screening results) and process measures (TC and nicotine patch adherence, primary care appointment) will positively affect cessation outcomes at 3-, 6- and 12-months. H.1.3. Moderators include screening result, readiness to quit, and nicotine dependence.
  2. To evaluate reach (% of current smokers enrolled) and engagement (% who receive the interventions), both overall and among subgroups (gender, age, nicotine dependence, site). The investigators will assess intervention fidelity and feasibility for implementation, from both community-based and academically-based screening centers.
  3. To conduct an economic analysis to test the hypothesis that while costlier, ITC will be more effective and have greater reach than UC in the lung screening setting, making it more cost-effective in terms of costs per 3-, 6- and 12-month cessation rates and quit attempts. The investigators will use these results as inputs to the CISNET model to project the long-term impact of the interventions on costs per life year saved and quality-adjusted life years saved, lung cancer deaths averted, lung cancer mortality reduction, and overall population mortality.

This study's strengths include the assessment of effective cessation methods designed for widespread implementation, novel components based on unique features of screening, cost-effectiveness analyses, and leveraging the University of Michigan CISNET model to project the population impact of implementing an effective cessation intervention in lung screening programs. The overall goal is to have a substantial public health impact by providing critical data to address scalability efforts by screening centers, insurers, and policy-makers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Integrating Evidence-Based Smoking Cessation Interventions Into Lung Cancer Screening Programs: A Randomized Trial
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intensive Telephone Counseling
This arm provides a multi-faceted, 8-session intensive telephone counseling (ITC) protocol, tailored on lung cancer screening results, with 8-weeks of free nicotine replacement patches provided (Nicoderm patch, 21mg, 14mg, and 7mg) and primary care engagement.
Behavioral: Intensive Telephone Counseling (8 sessions) with nicotine replacement
Participants are provided up to 8 counseling sessions lasting approximately 20 minutes each and access to 8-weeks of free nicotine replacement patches. A counselor-initiated discussion of screening results will also be included throughout the counseling sessions.

Active Comparator: Usual Care
This arm provides a multi-faceted, 3-session usual care telephone counseling (UC) protocol, with 2-weeks of free nicotine replacement patches provided (Nicoderm patch, 21mg, 14mg, and 7mg) and primary care engagement.
Behavioral: Usual Care: Telephone counseling (3 sessions) with nicotine replacement
Participants are provided up to 3 counseling sessions lasting approximately 20 minutes each and access to 2-weeks of free nicotine replacement patches.




Primary Outcome Measures :
  1. Smoking cessation rate at 3-months post-randomization [ Time Frame: Self-report measured at 3-months post-randomization; biochemical verification measured at 3-months. ]
    Comparison between study arms of 7-day and 30-day point prevalence cessation with biochemical verification. The investigators will also assess quit rates among subgroups (gender, age, nicotine dependence, site).

  2. Smoking cessation rate at 6-months post-randomization [ Time Frame: Self-report measured at 6-months post-randomization; biochemical verification measured at 6-months. ]
    Comparison between study arms of 7-day and 30-day point prevalence cessation with biochemical verification. The investigators will also assess quit rates among subgroups (gender, age, nicotine dependence, site).

  3. Smoking cessation rate at 12-months post-randomization [ Time Frame: Self-report measured at 12-months post-randomization; biochemical verification measured at 12-month assessment; ]
    Comparison between study arms of 7-day and 30-day point prevalence cessation. The investigators will also assess quit rates among subgroups (gender, age, nicotine dependence, site).


Secondary Outcome Measures :
  1. Readiness to quit [ Time Frame: Measured at baseline (T0), 1-2 days post-receipt of screening result (T1), and 3-months (T2), 6-months (T3), and 12-months post-randomization (T4). ]
    Measured using the 10-point contemplation ladder.

  2. Quit attempts [ Time Frame: Baseline (T0), 1-2 days post-receipt of screening result (T1),3-, 6- and 12- months post-randomization (T2, T3, T4) ]
    The investigators will assess the number and length of prior quit attempts at baseline. At all follow-up assessments, the investigators will assess the number and length of quit attempts that have occurred since the previous assessment.

  3. TC intervention fidelity [ Time Frame: Through study completion, an average of 3 months post-randomization. ]
    Measurement of counselor adherence to the TC protocol, which will be assessed on 10% of randomly selected participants.

  4. Patient reach and patient engagement [ Time Frame: Through study completion, an average of 3 months post-randomization. ]
    Reach: % of eligible smokers enrolled in trial; Engagement: % who receive the TC and the nicotine patch interventions), both overall and among subgroups (gender, age, nicotine dependence, site)

  5. Costs per arm for study outcomes [ Time Frame: Through study completion, an average of 3 months post-randomization. ]
    Patient time costs in the interventions; fixed costs (space, overhead) and variable costs (intervention delivery and patient participation) by arm

  6. Cigarettes smoked per day [ Time Frame: Measured at baseline (T0), 1-2 days post-receipt of screening result (T1), 3-months post-randomization (T2), 6 months post randomization (T3) and 12 months post randomization (T4) ]
    Number of cigarettes per day



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have a >20-pack year smoking history (i.e., smoked at least a pack a day for 20 years)
  • Current smokers, regardless of number smoked per day
  • Can be smoking cigarettes, cigarillos, or little cigars
  • English- or Spanish-speaking
  • Ability to provide meaningful consent
  • Have registered for CT lung cancer screening at one of our five participating lung screening sites (for enrollment) and have completed CT lung cancer screening (for subsequent follow-ups).
  • Current smokers are eligible to participate regardless of prior lung cancer screening or prior cessation treatment. Smokers not yet ready to quit will be encouraged to participate.

Exclusion Criteria:

  • Previously diagnosed with lung cancer
  • Diagnosed with lung cancer during the study (although still eligible to receive free telephone counseling and nicotine replacement)
  • At the T1 assessment when randomization occurs, individuals who have been quit for 8+ days will not be randomized. We will request that they participate in follow-up assessments of smoking status at 3-, 6- and 12-months.

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): NCT03200236


Contacts
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Contact: Kathryn L. Taylor, PhD 202-687-0649 taylorkl@georgetown.edu

Locations
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United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Kathryn L Taylor, PhD    202-687-0649    taylorkl@georgetown.edu   
United States, Florida
Baptist Health South Florida Recruiting
Miami, Florida, United States, 33176
Contact: Juan Batlle, MD    786-527-7525    juan@alumni.upenn.edu   
United States, Illinois
UnityPoint Health --Trinity Medical Center Recruiting
Moline, Illinois, United States, 61265
Contact: Judith Howell, RN       judith.howell@unitypoint.org   
United States, Maryland
Anne Arundel Medical Center Recruiting
Annapolis, Maryland, United States, 21401
Contact: Maria Geronimo, MBA, MSN, RN       mgeronimo@aahs.org   
Contact: Joanne Ebner, RN, BSN, OCN       jebner@aahs.org   
MedStar Shah Medical Group Recruiting
Hollywood, Maryland, United States, 20636
Contact: Vicky Parikh, MD       Vicky.Parikh@medstar.net   
Contact: Melissa Harris, CCRP       melissa.renee.harris@medstar.net   
United States, Massachusetts
Lahey Hospital and Medical Center Not yet recruiting
Burlington, Massachusetts, United States, 01805
Contact: Brady J McKee, MD         
Contact    (781) 744-8170    Brady.J.McKee@lahey.org   
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Michael Ramsaier    551-996-3384    michael.ramsaier@hackensackmeridian.org   
Sponsors and Collaborators
Georgetown University
Hackensack Meridian Health
Baptist Health South Florida
Lahey Hospital & Medical Center
University of Michigan
National Cancer Institute (NCI)
Unity Point Health
MedStar Shah Medical Group
Anne Arundel Medical Center
Publications:

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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT03200236    
Other Study ID Numbers: 2016-0651
R01CA207228-01 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified patient data will be shared with the National Cancer Institute as part of the SCALE collaboration.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Georgetown University:
Lung Cancer Screening
Smoking Cessation
Tobacco Use
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action