Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

NCT ID: NCT03315910

Last Updated: 2025-11-24

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

807 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-10

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

The investigators have chosen to conduct a full factorial experimental design.
Primary Study Purpose

PREVENTION

Blinding Strategy

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.

Group Type EXPERIMENTAL

Motivational Interviewing (MI)

Intervention Type BEHAVIORAL

two counseling sessions

saliva sample

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Nicotine Replacement Therapy (NRT)

Intervention Type DRUG

receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day

saliva sample

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Nicotine Lozenge

Intervention Type DRUG

6 packs of NRT 2mg lozenge

saliva sample

Intervention Type OTHER

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).

Group Type EXPERIMENTAL

Message Framing

Intervention Type BEHAVIORAL

health communication literature and quitting messages

saliva sample

Intervention Type OTHER

saliva samples from those reporting abstinence and analyze samples

Interventions

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Motivational Interviewing (MI)

two counseling sessions

Intervention Type BEHAVIORAL

Nicotine Replacement Therapy (NRT)

receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day

Intervention Type DRUG

Nicotine Lozenge

6 packs of NRT 2mg lozenge

Intervention Type DRUG

Message Framing

health communication literature and quitting messages

Intervention Type BEHAVIORAL

saliva sample

saliva samples from those reporting abstinence and analyze samples

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

John Muir Health

Walnut Creek, California, United States

Site Status

WellStar Health System

La Grange, Georgia, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Riverside Healthcare

Kankakee, Illinois, United States

Site Status

St. Mary Medical Center, Community Healthcare System

Crown Point, Indiana, United States

Site Status

MercyOne Des Moines Medical Center (Data Collection Only)

Des Moines, Iowa, United States

Site Status

Maine Medical Center Cancer Institute

Scarborough, Maine, United States

Site Status

Henry Ford Hospital (Data collection only)

Detroit, Michigan, United States

Site Status

Munson Healthcare

Traverse City, Michigan, United States

Site Status

NYU Winthrop Hospital

Mineola, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Weill Cornell Medical Center

New York, New York, United States

Site Status

Montefiore Medical Center (Data Collection Only)

The Bronx, New York, United States

Site Status

Carolinas Healthcare System Blue Ridge

Morganton, North Carolina, United States

Site Status

Fairfield Medical Center

Lancaster, Ohio, United States

Site Status

Legacy Health

Portland, Oregon, United States

Site Status

Temple University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 35978334 (View on PubMed)

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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17-500

Identifier Type: -

Identifier Source: org_study_id

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