Phase 2
N=367
Gain-framed Messages and NRT for Lung Cancer Screening Patients
Lung Cancer Screening · Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT03069924 ↗Enrolled (actual)
367
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Smoking Cessation - Available Data — 15; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gain-framed messaging (Behavioral); Unframed messaging materials (Combination_product)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Cessation - Available Data |
15; 19 | — |
| SECONDARY Cigarettes Smoked Per Day - Average |
9.7; 8.9 | — |
| SECONDARY Smoking Cessation - Imputed |
15; 19 | — |
Summary
This research is a randomized smoking cessation trial conducted within and specifically personalized for lung cancer screening patients presenting to a lung screening clinic. Novel tobacco treatments for this population are critically needed, given the growing population of lung screening patients, which will grow dramatically now that lung screening is an approved CMS benefit. In the proposed study, we will test a gain-framed messaging intervention specifically designed for lung screening patients (vs. unframed messaging), as well as evaluating NRT sampling (vs. no medication) at 2 study sites. Our project is designed to be translational (in that it can be transferable from our controlled efficacy study to other lung screening programs).
Eligibility Criteria
Inclusion Criteria
- 50 years or older
- at least a 20-pack year history of smoking
- current smoker (defined as any smoking in the past 30 days)
- willing to be randomized
- English speaking
Exclusion Criteria
- unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia,
- known allergy to adhesives
- being in the immediate (within 2 weeks) post myocardial infarction period
- serious arrhythmias
- unstable angina pectoris
- hemodynamically or electrically unstable.
- current participation in another tobacco treatment program (e.g., using medication from a primary care doctor, Quitline, etc.)
Data sourced from ClinicalTrials.gov (NCT03069924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.