Gain-framed Messages and NRT for Lung Cancer Screening Patients

NCT03069924 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: Pro000553975R01CA207229-06
• Study Type: interventional
• Target: 367
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Lung Cancer Screening; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Cigarettes Smoked Per Day - Average

  6 month follow-up

• Smoking Cessation - Imputed

  6 Month Follow up Visit

Study Arms (2)

Unframed Messaging

ACTIVE COMPARATOR

Unframed smoking cessation materials

Combination Product: Unframed messaging materials

Gain-framed Messaging

EXPERIMENTAL

Gain-framed messaging

Behavioral: Gain-framed messaging

Interventions

Gain-framed messaging BEHAVIORAL

Gain-framed messaging materials

Gain-framed Messaging

Unframed messaging materials COMBINATION_PRODUCT

Unframed smoking cessation materials

Unframed Messaging

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Yale Cancer Center

New Haven, Connecticut, 06510, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Benjamin Toll
• Organization: Medical University of South Carolina

toll@musc.edu

843-876-1132

Study Officials

• Benjamin Toll, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Alana Rojewski, PhD

  Medical University of South Carolina

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 3, 2017
• Study Start: July 1, 2017
• Primary Completion: November 10, 2023
• Study Completion: August 10, 2024
• Last Updated: January 14, 2025
• Results First Posted: November 14, 2024

Record last verified: 2025-01

Locations

US (2)