Clinical trial

Gain-framed Messages and NRT Sampling to Promote Smoking Cessation in Lung Cancer Screening Programs

Name
Pro00055397
Description
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).
Trial arms
Trial start
2017-07-01
Estimated PCD
2023-11-10
Trial end
2024-11-10
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Gain-framed messaging plus NRT
Gain-framed messaging materials and NRT
Arms:
NRT plus Gain-framed Messaging
Unframed messaging materials
Unframed smoking cessation materials
Arms:
No NRT - Unframed Messaging
Size
367
Primary endpoint
Smoking cessation rates
6 month follow-up
Eligibility criteria
Inclusion Criteria: 1. 50 years or older 2. at least a 20-pack year history of smoking 3. current smoker (defined as any smoking in the past 30 days) 4. willing to be randomized 5. English speaking Exclusion Criteria: 1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia, 2. known allergy to adhesives 3. being in the immediate (within 2 weeks) post myocardial infarction period 4. serious arrhythmias 5. unstable angina pectoris 6. hemodynamically or electrically unstable. 7. current participation in another tobacco treatment program (e.g., using medication from a primary care doctor, Quitline, etc.)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 367, 'type': 'ESTIMATED'}}
Updated at
2024-01-09

1 organization

1 product

2 indications