Gain-framed Messages and NRT for Lung Cancer Screening Patients

Phase 2

Completed

• Conditions: Lung Cancer Screening; Smoking Cessation
• Interventions: Behavioral: Unframed messaging materials; Combination Product: Gain-framed messaging plus NRT

• Registration Number: NCT03069924
• Lead Sponsor: Medical University of South Carolina

Brief 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-03
• Study Start: 2017-07-01
• Primary Completion: 2023-11-10
• Study Completion: 2024-08-10
• Status Verified: 2024-10
• Results First Submitted: 2024-10-22
• Results First Submitted QC: 2024-10-22
• Last Update Submitted: 2024-10-22
• Results First Posted: 2024-11-14
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 367

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

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No NRT - Unframed Messaging	Unframed messaging materials	Unframed smoking cessation materials, but no NRT and no gain-framed messaging.
NRT plus Gain-framed Messaging	Gain-framed messaging plus NRT	Gain-framed messaging plus NRT.

Primary Outcome Measures

Name	Time	Method
Smoking Cessation - Available Data	6 month follow-up	Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit

Secondary Outcome Measures

Name	Time	Method
Cigarettes Smoked Per Day - Average	6 month follow-up	Gain-framed messaging vs. Unframed messaging - average reported cigarettes smoked per day.
Smoking Cessation - Imputed	6 Month Follow up Visit	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.

Trial Locations

Locations (2)

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States