Clinical trial · Interventional
Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites
NCT03315910CI-TRIAL-00097820active not recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Smoking Cessation | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Message Framing | Behavioral | — | UNRESOLVED |
| Motivational Interviewing (MI) | Behavioral | — | UNRESOLVED |
| Nicotine Lozenge | Drug | — | UNRESOLVED |
| Nicotine Replacement Therapy (NRT) | Drug | — | UNRESOLVED |
| saliva sample | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Motivational Interviewing( MI) (Yes vs. No)
- description
- 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.
- interventionNames
- Behavioral: Motivational Interviewing (MI)
- Other: saliva sample
- type
- EXPERIMENTAL
- label
- Nicotine Replacement Therapy (NRT) Patch (Yes vs. No)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDOstroff 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 35978334