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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Removal of Financial Barriers; Behavioral: Financial Incentives; Behavioral: Mobile Health Application

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 Type: Interventional
• Enrollment (Actual): 3228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Southern California
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger
    • Lancaster, Pennsylvania, United States, 17601
      • Lancaster General Health
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Basic Usual Care; Participants receive the usual care approach, Ask-Advise-Refer (AAR), which is a standard approach in which non-study clinicians ask smokers about their desire to quit smoking, advise them to quit, and provide informational resources such as hotlines, specialized clinics, or smoking cessation classes.
Active Comparator: Enhanced Usual Care; Participants receive the basic usual care of Ask-Advise-Refer as well as free access to nicotine replacement therapy (NRT) and/or reimbursement of up to $300 for any smoking cessation medications (varenicline/Chantix or bupropion/Zyban) prescribed by non-study clinicians.	Behavioral: Removal of Financial Barriers; Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications; Other Names: NRT; Pharmacotherapy
Active Comparator: Enhanced Usual Care plus Financial Incentives; Participants receive all aspects of enhanced usual care plus an incentive plan in which they will be informed of their eligibility to earn $100, $200, and $300 if they submit negative tests for nicotine metabolites at 2 weeks, 3 month and 6 months following their quit date, respectively.	Behavioral: Removal of Financial Barriers; Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications; Other Names: NRT; Pharmacotherapy; Behavioral: Financial Incentives; Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.; Other Names: Incentives
Active Comparator: Enhanced Usual Care plus Financial Incentives plus Mobile Health Application; Participants receive all aspects of Arm 3 plus an intervention to promote episodic future thinking (EFT), called FutureMe. EFT has been shown to reliably reduce discounting of the future. Patients will practice using EFT cues to envision the "future is now" between the time of enrollment and the quit date, and will then receive cues from the quit date through the end of the intervention period, 6 months later, unless they ask to stop receiving cues sooner.	Behavioral: Removal of Financial Barriers; Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications; Other Names: NRT; Pharmacotherapy; Behavioral: Financial Incentives; Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.; Other Names: Incentives; Behavioral: Mobile Health Application; Episodic future thinking tool to overcome temporal discounting of future; Other Names: FutureMe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically Confirmed Smoking Abstinence Sustained for 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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quit Status (Biochemically Confirmed)	Rates of sustained biochemically confirmed smoking cessation	2 weeks, 3 months, 12 months
Health-related Quality of Life	The EuroQuol Group's quality of life (EQ-5D-5L) 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. Scale range: -1 to 1 index calculated from SAS package provided by author. Additionally calculating misery score which is sum of scores ranging from 5 to 25. For index, 1 is best possible health, while -1 are states worse than death. For the misery score, higher is worse health.	Baseline
Perceived Barriers to Cessation	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), 9 item intrinsic factors scale from 9-36, and extrinsic factors (social or environmental aspects of quitting), 12 item extrinsic factors scale from 12-43. Total score was also prepared, range 21-79. A higher score means a greater challenge.	Baseline
Self-efficacy Related to Cessation Efforts	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. The scale ranges from 10-40, with a higher score demonstrating more self-efficacy.	Baseline
Motivation to Quit	The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit.	Baseline
Temporal ("Delay") Discounting	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. The scale ranges from 0.000110 to 24, with a higher value meaning present is valued more over future gain. K values were calculated in R using the values noted in Koffarnus & Bickel 2014.	Baseline
Health-related Quality of Life	The EuroQuol Group's quality of life (EQ-5D-5L) 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. Scale range: -1 to 1 index calculated from SAS package provided by author. Additionally calculating misery score which is sum of scores ranging from 5 to 25. For index, 1 is best possible health, while -1 are states worse than death. For the misery score, higher is worse health.	6 months
Perceived Barriers to Cessation	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), 9 item intrinsic factors scale from 9-36, and extrinsic factors (social or environmental aspects of quitting), 12 item extrinsic factors scale from 12-43. Total score was also prepared, range 21-79. A higher score means a greater challenge.	6 months
Self-efficacy Related to Cessation Efforts	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. The scale ranges from 10-40, with a higher score demonstrating more self-efficacy.	6 months
Motivation to Quit	The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit.	6 months
Temporal ("Delay") Discounting	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. The scale ranges from 0.000110 to 24, with a higher value meaning present is valued more over future gain. K values were calculated in R using the values noted in Koffarnus & Bickel 2014.	6 months
Health-related Quality of Life	The EuroQuol Group's quality of life (EQ-5D-5L) 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. Scale range: -1 to 1 index calculated from SAS package provided by author. Additionally calculating misery score which is sum of scores ranging from 5 to 25. For index, 1 is best possible health, while -1 are states worse than death. For the misery score, higher is worse health.	12 months
Perceived Barriers to Cessation	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), 9 item intrinsic factors scale from 9-36, and extrinsic factors (social or environmental aspects of quitting), 12 item extrinsic factors scale from 12-43. Total score was also prepared, range 21-79. A higher score means a greater challenge.	12 months
Self-efficacy Related to Cessation Efforts	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. The scale ranges from 10-40, with a higher score demonstrating more self-efficacy.	12 months
Motivation to Quit	The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit.	12 months
Temporal ("Delay") Discounting	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. The scale ranges from 0.000110 to 24, with a higher value meaning present is valued more over future gain. K values were calculated in R using the values noted in Koffarnus & Bickel 2014.	12 months
Self-report Cigarette Abstinence	Rates of sustained self-reported cigarette abstinence	2 weeks, 3 months, 6 months, 12 months
Self-report Other Tobacco Abstinence	Rates of sustained self-reported other tobacco abstinence	2 weeks, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Scott D Halpern, MD PhD, University of Pennsylvania

Publications and helpful links

General Publications

• Kohn R, Vachani A, Small D, Stephens-Shields AJ, Sheu D, Madden VL, Bayes BA, Chowdhury M, Friday S, Kim J, Gould MK, Ismail MH, Creekmur B, Facktor MA, Collins C, Blessing KK, Neslund-Dudas CM, Simoff MJ, Alleman ER, Epstein LH, Horst MA, Scott ME, Volpp KG, Halpern SD, Hart JL; Stakeholder Advisory Committee. Comparing Smoking Cessation Interventions among Underserved Patients Referred for Lung Cancer Screening: A Pragmatic Trial Protocol. Ann Am Thorac Soc. 2022 Feb;19(2):303-314. doi: 10.1513/AnnalsATS.202104-499SD.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): November 4, 2024
• Study Completion (Actual): April 29, 2025

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Lung Cancer; Smoking Cessation; Nicotine Dependence; Early Detection of Cancer; Incentives; Behavioral Economics; Nicotine Replacement Products; Patients, Underserved
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Health Behavior; Lung Neoplasms; Tobacco Use Disorder; Smoking Cessation; Therapeutics; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Drug Therapy; Fertility
• Other Study ID Numbers: UPCC 12519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie published results will be made available to other researchers, after de-identification.
• IPD Sharing Time Frame: Beginning 9 months after publication and up to 36 months following publication. After 36 months the data will be available in our University's data warehouse but without support, except for deposited metadata.
• IPD Sharing Access Criteria: Proposals for data use will be reviewed by Principal Investigator and independent review board (such as the Data and Safety Monitoring Board). Approved requestors will need to sign data use agreements to access and use data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No