Gain-framed Messages and NRT for Lung Cancer Screening Patients

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 2

Conditions: Lung Cancer Screening; Smoking Cessation

Treatments: Combination Product: Unframed messaging materials; Behavioral: Gain-framed messaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03069924

5R01CA207229-06 (U.S. NIH Grant/Contract)

Pro00055397

Details and patient eligibility

About

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).

Enrollment: 367 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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367 participants in 2 patient groups

Unframed Messaging

Active Comparator group

Description:

Unframed smoking cessation materials

Treatment:

Combination Product: Unframed messaging materials

Gain-framed Messaging

Experimental group

Description:

Gain-framed messaging

Treatment:

Behavioral: Gain-framed messaging