Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites
NCT ID: NCT03315910
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
807 participants
INTERVENTIONAL
2017-10-10
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Motivational Interviewing( MI) (Yes vs. No)
Participants will receive two motivational informed cessation sessions; the first delivered face to faceor via telephone by the SC during the patient's initial lung cancer screening visit or during the shared decision making discussion or within about 1 week following their screening visit, and the second session delivered by telephone by the SC approximately 4 to 8 weeks after the first MI session.
Motivational Interviewing (MI)
two counseling sessions
saliva sample
saliva samples from those reporting abstinence and analyze samples
Nicotine Replacement Therapy (NRT) Patch (Yes vs. No)
Participants will receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day and written instructions to use the patch daily starting on date they mutually agreed upon with their site coordinator. Participants who smoke fewer than 10 cigarettes per day will receive 4-weeks of the 14mg patch (2 boxes), and 2-weeks of the 7mg patch (1 box). Those who smoke 10 or more cigarettes per day will receive 4-weeks of the 21mg patch (2 boxes) and 2-weeks of the 14mg patch (1 box). Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion \& Fulfillment.
Nicotine Replacement Therapy (NRT)
receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day
saliva sample
saliva samples from those reporting abstinence and analyze samples
NRT Lozenge (Yes vs. No)
Participants will receive will receive 6 packs of NRT 2mg lozenge and written instructions to use the lozenge PRN to help manage acute nicotine withdrawal. Participants will be instructed to use the NRT lozenges no more than every 1-2 hours as needed. Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion \& Fulfillment.
Nicotine Lozenge
6 packs of NRT 2mg lozenge
saliva sample
saliva samples from those reporting abstinence and analyze samples
Message Framing (Gain vs. Loss)
Overall, a robust body of health communication literature demonstrates that gain-framed messages may be more effective than loss-framed or non-framed (neutral) messages for encouraging smoking cessation. In other words, quitting messages that promote smoking cessation are more persuasive if they emphasize the benefits of quitting (gain-framed) rather than the risks (loss-framed) of persistent smoking (25, 26). Included with the written communication of their LDCT-LCS results, participants will receive a printed individualized quitting message that emphasizes either the benefits of quitting (gain-framed) or the risks of continuing to smoke (loss-framed).
Message Framing
health communication literature and quitting messages
saliva sample
saliva samples from those reporting abstinence and analyze samples
Interventions
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Motivational Interviewing (MI)
two counseling sessions
Nicotine Replacement Therapy (NRT)
receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day
Nicotine Lozenge
6 packs of NRT 2mg lozenge
Message Framing
health communication literature and quitting messages
saliva sample
saliva samples from those reporting abstinence and analyze samples
Eligibility Criteria
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Inclusion Criteria
\& Must be designated as an American College of Radiology (ACR) designated lung cancer screening site
* Reports at least one year of lung cancer screening experience
* Reports conducting at least 20 new initial screenings per month Site Coordinator (SC) Eligibility (as per SC self-report)
* Employed as a full-time Site Coordinator at participating lung cancer screening site Patient Eligibility (as per self-report)
* Between the ages of 50-80 years old
* Seeking baseline or annual follow-up LDCT lung cancer screening
* Have at least a 20 pack-year history of smoking
* Currently a smoker, defined as self-reported cigarette smoking (some days, every day) within the past 30 days.
* Must be reachable by telephone
* Must be English or Spanish speaking due to the study materials being available in only these languages and limited available resources for translation.
Exclusion Criteria
* NRT is medically contraindicated (e.g., recent heart attack within the last 2 weeks or, unstable/worsening angina).
* Smokers who are receiving other tobacco treatment services or have used cessation medications (NRT, bupropion, varenicline) within the past month.
50 Years
80 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jamie Ostroff, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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University of Southern California (Data Collection Only)
Los Angeles, California, United States
John Muir Health
Walnut Creek, California, United States
WellStar Health System
La Grange, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Riverside Healthcare
Kankakee, Illinois, United States
St. Mary Medical Center, Community Healthcare System
Crown Point, Indiana, United States
MercyOne Des Moines Medical Center (Data Collection Only)
Des Moines, Iowa, United States
Maine Medical Center Cancer Institute
Scarborough, Maine, United States
Henry Ford Hospital (Data collection only)
Detroit, Michigan, United States
Munson Healthcare
Traverse City, Michigan, United States
NYU Winthrop Hospital
Mineola, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
Montefiore Medical Center (Data Collection Only)
The Bronx, New York, United States
Carolinas Healthcare System Blue Ridge
Morganton, North Carolina, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Legacy Health
Portland, Oregon, United States
Temple University
Philadelphia, Pennsylvania, United States
Countries
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References
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Ostroff JS, Shelley DR, Chichester LA, King JC, Li Y, Schofield E, Ciupek A, Criswell A, Acharya R, Banerjee SC, Elkin EB, Lynch K, Weiner BJ, Orlow I, Martin CM, Chan SV, Frederico V, Camille P, Holland S, Kenney J. Study protocol of a multiphase optimization strategy trial (MOST) for delivery of smoking cessation treatment in lung cancer screening settings. Trials. 2022 Aug 17;23(1):664. doi: 10.1186/s13063-022-06568-3.
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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17-500
Identifier Type: -
Identifier Source: org_study_id
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