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Gain-framed Messages and NRT for Lung Cancer Screening Patients

Medical University of South Carolina (MUSC) logo

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)

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

Trial documents
2

Trial contacts and locations

2

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Central trial contact

Marian Chelsea Evangelista; Benjamin Toll, PhD

Data sourced from clinicaltrials.gov

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