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OpenTrials
Completed

NCT Number: NCT03069924

Gain-framed Messages and NRT for Lung Cancer Screening Patients

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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Key information

Conditions

Lung Cancer Screening Behavior Health Behavior Smoking Cessation

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale Cancer Center, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Gain-framed messaging

Behavioral

Gain-framed messaging materials

Unframed messaging materials

Combination Product

Unframed smoking cessation materials

Primary outcomes

  1. 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

  1. Cigarettes Smoked Per Day - Average

    Time frame: 6 month follow-up

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

  2. Smoking Cessation - Imputed

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2024
First posted
Mar 3, 2017
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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