Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening

Not Applicable

Completed

• Conditions: Smoking Cessation

• Registration Number: NCT04798664
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

To compare the effectiveness of four interventions to promote sustained, biochemically confirmed smoking abstinence for 6 months among underserved smokers referred for lung cancer screening at four large U.S. health systems.

Detailed Description

We will conduct a 4-arm randomized trial comparing 4 interventions to promote sustained, biochemically confirmed smoking abstinence for 6 months among smokers in underserved demographic groups. The 3,200 participants to be enrolled will be current smokers who are Black, Hispanic, and/or have low socioeconomic status (defined as household income \<200% of the federal poverty line or a high school education or less) or rural residence who are referred for low-dose computed tomography (LDCT) screening at 4 large health systems. All adult patients with LDCT orders will be further screened for eligibility. Eligible patients will enroll with opt-out consent and complete the study using the NIH-funded Way to Health online research portal. The primary outcome will be biochemically confirmed, sustained abstinence from smoking tobacco for 6 months following participants' selected quit dates. Relapse rates will be tracked at 12 months.

Study Timeline

• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-15
• Study Start: 2021-05-17
• Primary Completion: 2024-11-04
• Study Completion: 2025-04-29
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3228

Inclusion Criteria

• Current smoker (≥ 1 cigarettes per day, not including e-cigarettes)
• Has a low-dose computed tomography (LDCT) scan ordered by their physician
• Underserved, defined as one or more of the following: (a) Black, (b) Hispanic, (c) rural residence, or (d) low socioeconomic status (Defined as one or both of: high-school education or less, or household income <200% of the federal poverty line)
• Able to receive study invitation and screening, by virtue of showing up to a radiology location affiliated with a participating health system for the LDCT, or having a valid email address or telephone number on file with the health system
• Access to a cell phone with text messaging or the internet
• Aged 18 years or older

Exclusion Criteria

• No cell phone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biochemically confirmed smoking abstinence sustained for 6 months	6 months	The primary outcome measure is sustained abstinence for 6 months, and will require self-report of smoking cessation followed by biochemical confirmation at 2 weeks, 3, and 6 months.

Secondary Outcome Measures

Name	Time	Method
Quit status (self-report)	2 weeks, 3 months, 6 months, 12 months	Point-prevalent rates of self-reported nicotine use and tobacco product use
Quit status (biochemically confirmed)	2 weeks, 3 months, 6 months,12 months	Point-prevalent rates of biochemically confirmed smoking cessation
Health-related quality of life	Baseline, 6 months, 12 months	The EuroQuol Group's quality of life (EQ-5D) scale is a 25-item validated scale used to assess patients' perceived health-related quality of life across the domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Perceived barriers to cessation	Baseline, 6 months, 12 months	The Challenges to Stopping Smoking Scale (CSS-21) is a validated 21-item measure to assess patients' perceived barriers to smoking cessation. The CSS-21 has two sub-scales: intrinsic factors (physical, psychological or cognitive aspects of quitting) and extrinsic factors (social or environmental aspects of quitting).
Temporal ("delay") discounting	Baseline, 6 months, 12 months	Temporal discounting is a measure of impulsivity that reflects people's tendencies to discount the value of a reward as a function of how far in the future it would be received. We will use the 5-Trial Adjusting Delay Task to assess temporal discounting.
Self-efficacy related to cessation efforts	Baseline, 6 months, 12 months	We will use the 10-item situational measure of self-efficacy related to smoking behavior. This scale measures how sure participants are that they can avoid smoking in different situations.
Motivation to quit	Baseline, 6 months, 12 months	The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit.

Trial Locations

Locations (5)

Kaiser Permanente Southern California; 🇺🇸 Oakland, California, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Geisinger; 🇺🇸 Danville, Pennsylvania, United States

Lancaster General Health; 🇺🇸 Lancaster, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States