Gain-framed Messages and NRT for Lung Cancer Screening Patients

Medical University of South Carolina367 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

367

Conditions

Lung Cancer Screening Smoking Cessation

Interventions

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.)

Locations (2)

Yale Cancer Center

New Haven, Connecticut, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Smoking Cessation - Available Data

Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit

Time frame: 6 month follow-up

Secondary Outcomes

Cigarettes Smoked Per Day - Average

Gain-framed messaging vs. Unframed messaging - average reported cigarettes smoked per day.

Time frame: 6 month follow-up

Smoking Cessation - Imputed

Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit. Missing participant data imputed to no cessation. 3 participants from the unframed group were not included as they had died prior to the 6-month visit.

Time frame: 6 Month Follow up Visit