Gain-framed Messages and NRT for Lung Cancer Screening Patients

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03069924
• Other study ID #: Pro00055397
• Secondary ID: 5R01CA207229-06
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 1, 2017
• Est. completion date: November 10, 2024

Study information

• Verified date: January 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 367
• Est. completion date: November 10, 2024
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Lung Cancer Screening
• Lung Neoplasms
• Smoking Cessation

Intervention

Combination Product:
• Gain-framed messaging plus NRT
Gain-framed messaging materials and NRT

Behavioral:
• Unframed messaging materials
Unframed smoking cessation materials

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Yale Cancer Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking cessation rates	NRT+Gain-framed messaging vs. No NRT+Unframed messaging	6 month follow-up
Secondary	Smoking cessation rates	Gain-framed messaging + NRT & Unframed messaging + NRT vs. Gain-framed messaging + No NRT & Unframed messaging + No NRT	6 month follow-up
Secondary	Smoking cessation rates	Gain-framed messaging + NRT & Gain-framed messaging + No NRT vs. Unframed messaging + NRT & Unframed messaging + No NRT	6 month follow-up
Secondary	Smoking cessation rates	Gain-framed messaging + NRT & Gain-framed messaging + No NRT & Unframed messaging + NRT vs. Unframed messaging + No NRT	6 month follow-up