Skip to main content
Clinical Trials/NCT03069924
NCT03069924CompletedPhase 2

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

Medical University of South Carolina4 sites in 1 country367 target enrollmentStarted: July 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
367
Locations
4
Primary Endpoint
Smoking Cessation - Available Data

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 50 years or older
  • at least a 20-pack year history of smoking
  • current smoker (defined as any smoking in the past 30 days)
  • willing to be randomized
  • English speaking

Exclusion Criteria

  • unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia,
  • known allergy to adhesives
  • being in the immediate (within 2 weeks) post myocardial infarction period
  • serious arrhythmias
  • unstable angina pectoris
  • hemodynamically or electrically unstable.
  • current participation in another tobacco treatment program (e.g., using medication from a primary care doctor, Quitline, etc.)

Outcomes

Primary Outcomes

Smoking Cessation - Available Data

Time Frame: 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 Outcomes

  • Cigarettes Smoked Per Day - Average(6 month follow-up)
  • Smoking Cessation - Imputed(6 Month Follow up Visit)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Benjamin Toll

Professor

Medical University of South Carolina

Study Sites (4)

Loading locations...

Similar Trials

Gain-framed Messages and NRT for Lung... | Clinical Trial