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

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 Overview

• Status: Active, not recruiting
• Conditions: Smoking Cessation; Lung Cancer Screening
• Intervention / Treatment: Behavioral: Unframed messaging materials; Combination product: Gain-framed messaging plus NRT

• Study Type: Interventional
• Enrollment (Estimated): 367
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Benjamin Toll, PhD; Phone Number: 843-876-1132; Email: toll@musc.edu
• Study Contact Backup: Name: Marian Chelsea Evangelista; Phone Number: 843-509-7589; Email: evangema@musc.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale Cancer Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No NRT - Unframed Messaging; Unframed smoking cessation materials, but no NRT and no gain-framed messaging.	Behavioral: Unframed messaging materials; Unframed smoking cessation materials
Experimental: NRT plus Gain-framed Messaging; Gain-framed messaging plus NRT.	Combination product: Gain-framed messaging plus NRT; Gain-framed messaging materials and NRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking cessation rates	NRT+Gain-framed messaging vs. No NRT+Unframed messaging	6 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking cessation rates	Gain-framed messaging + NRT & Unframed messaging + NRT vs. Gain-framed messaging + No NRT & Unframed messaging + No NRT	6 month follow-up
Smoking cessation rates	Gain-framed messaging + NRT & Gain-framed messaging + No NRT vs. Unframed messaging + NRT & Unframed messaging + No NRT	6 month follow-up
Smoking cessation rates	Gain-framed messaging + NRT & Gain-framed messaging + No NRT & Unframed messaging + NRT vs. Unframed messaging + No NRT	6 month follow-up

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Benjamin Toll, PhD, Medical University of South Carolina; Study Director: Alana Rojewski, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): November 10, 2023
• Study Completion (Estimated): November 10, 2024

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: Pro00055397; 5R01CA207229-06 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No