Gain-framed Messages and NRT for Lung Cancer Screening Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

367 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2024-08-10

Brief Summary

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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).

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Detailed Description

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Conditions

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Lung Cancer Screening Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unframed Messaging

Unframed smoking cessation materials

Group Type ACTIVE_COMPARATOR

Unframed messaging materials

Intervention Type COMBINATION_PRODUCT

Unframed smoking cessation materials

Gain-framed Messaging

Gain-framed messaging

Group Type EXPERIMENTAL

Gain-framed messaging

Intervention Type BEHAVIORAL

Gain-framed messaging materials

Interventions

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Gain-framed messaging

Gain-framed messaging materials

Intervention Type BEHAVIORAL

Unframed messaging materials

Unframed smoking cessation materials

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.)

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes