Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites
1 other identifier
interventional
807
1 country
18
Brief Summary
This study is to help determine the most effective type or combination of treatments to offer patients seeking lung cancer screening who are smokers to help them reduce the number of cigarettes they smoke, or quit smoking. The investigators long term goal is to increase the benefits of lung cancer screening by providing a blue print of best practices for screening sites to deliver tobacco treatment to their patients who are smokers, in a way that does not add burden to screening site staff and increases the chances of patients quitting smoking.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2017
Longer than P75 for phase_4
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2017
CompletedFirst Submitted
Initial submission to the registry
October 17, 2017
CompletedFirst Posted
Study publicly available on registry
October 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
November 24, 2025
November 1, 2025
9 years
October 17, 2017
November 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of patients who are tobacco abstinence
biochemical verification of smoking abstinence will be conducted Consistent with Intent to Treat, unless self reported smoking abstinence is biochemically verified, (\<3 ng/ml for mailed salivary cotinine assay) for participants who fail to return the saliva sample, the cessation outcome will be considered non-abstinent.
6 months following study enrollment
Study Arms (4)
Motivational Interviewing( MI) (Yes vs. No)
EXPERIMENTALParticipants 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.
Nicotine Replacement Therapy (NRT) Patch (Yes vs. No)
EXPERIMENTALParticipants 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.
NRT Lozenge (Yes vs. No)
EXPERIMENTALParticipants 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.
Message Framing (Gain vs. Loss)
EXPERIMENTALOverall, 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).
Interventions
two counseling sessions
receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day
health communication literature and quitting messages
saliva samples from those reporting abstinence and analyze samples
Eligibility Criteria
You may qualify if:
- Site Eligibility (as per SC self-report)
- \& 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.
You may not qualify if:
- Patient (as per self-report)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
University of Southern California (Data Collection Only)
Los Angeles, California, 90033, United States
John Muir Health
Walnut Creek, California, 94598, United States
WellStar Health System
La Grange, Georgia, 30240, United States
Rush University Medical Center
Chicago, Illinois, 606012, United States
Riverside Healthcare
Kankakee, Illinois, 60901, United States
St. Mary Medical Center, Community Healthcare System
Crown Point, Indiana, 46307, United States
MercyOne Des Moines Medical Center (Data Collection Only)
Des Moines, Iowa, 50314, United States
Maine Medical Center Cancer Institute
Scarborough, Maine, 04074, United States
Henry Ford Hospital (Data collection only)
Detroit, Michigan, 48202, United States
Munson Healthcare
Traverse City, Michigan, 49684, United States
NYU Winthrop Hospital
Mineola, New York, 11501, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Weill Cornell Medical Center
New York, New York, 10065, United States
Montefiore Medical Center (Data Collection Only)
The Bronx, New York, 10467, United States
Carolinas Healthcare System Blue Ridge
Morganton, North Carolina, 28655, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Legacy Health
Portland, Oregon, 97210, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Related Publications (1)
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.
PMID: 35978334DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie Ostroff, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2017
First Posted
October 20, 2017
Study Start
October 10, 2017
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
November 24, 2025
Record last verified: 2025-11