NCT03069924|CompletedPhase 2ResultsFDA Drug
Gain-framed Messages and NRT for Lung Cancer Screening Patients
Gain-framed Messages and NRT Sampling to Promote Smoking Cessation in Lung Cancer Screening Programs
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Sponsor study identifier
Secondary identifiers
interventional
367
1 country
2
Study Start
July 1, 2017
Actual (reported)Primary Completion
November 10, 2023
Actual (reported)Study Completion
August 10, 2024
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 10, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 28, 2017
Actual (reported)March 3, 2017
Actual (reported)July 1, 2017
Actual (reported)November 10, 2023
Actual (reported)August 10, 2024
Actual (reported)November 14, 2024
Actual (reported)Smoking Cessation - Available Data
Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit
6 month follow-up
Cigarettes Smoked Per Day - Average
6 month follow-up
Smoking Cessation - Imputed
6 Month Follow up Visit
Unframed smoking cessation materials
Gain-framed messaging
Gain-framed messaging materials
Unframed smoking cessation materials
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Yale Cancer Center
New Haven, Connecticut, 06510, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Due to low accrual for this clinical trial during the COVID pandemic, we worked with our study statistician and NCI Program Officer to collapse our 4 arm trial to 2 arms. This allowed us to meet our accrual goal and complete the study while still retaining the ability to test our Primary Aim.
Benjamin Toll, PhD
Medical University of South Carolina
Alana Rojewski, PhD
Medical University of South Carolina
367 participants (actual enrollment reported by the registry).
First Submitted
February 28, 2017
First Posted
March 3, 2017
Study Start
July 1, 2017
Actual (reported)Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)
Contact the study team to confirm eligibility.
Primary Completion
November 10, 2023
Actual (reported)Study Completion
August 10, 2024
Actual (reported)Last Updated
January 14, 2025
Results First Posted
November 14, 2024
Record last verified: 2025-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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