Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening
1 other identifier
interventional
3,228
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedStudy Start
First participant enrolled
May 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2025
CompletedResults Posted
Study results publicly available
February 25, 2026
CompletedFebruary 25, 2026
February 1, 2026
3.5 years
March 11, 2021
October 21, 2025
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (18)
Quit Status (Biochemically Confirmed)
2 weeks, 3 months, 12 months
Health-related Quality of Life
Baseline
Perceived Barriers to Cessation
Baseline
Self-efficacy Related to Cessation Efforts
Baseline
Motivation to Quit
Baseline
- +13 more secondary outcomes
Study Arms (4)
Basic Usual Care
NO INTERVENTIONParticipants 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.
Enhanced Usual Care
ACTIVE COMPARATORParticipants 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.
Enhanced Usual Care plus Financial Incentives
ACTIVE COMPARATORParticipants 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.
Enhanced Usual Care plus Financial Incentives plus Mobile Health Application
ACTIVE COMPARATORParticipants 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.
Interventions
Episodic future thinking tool to overcome temporal discounting of future
Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications
Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- No cell phone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Kaiser Permanente Southern California
Oakland, California, 94612, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Geisinger
Danville, Pennsylvania, 17822, United States
Lancaster General Health
Lancaster, Pennsylvania, 17601, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 34384042DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Shira Blady
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Scott D Halpern, MD PhD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2021
First Posted
March 15, 2021
Study Start
May 17, 2021
Primary Completion
November 4, 2024
Study Completion
April 29, 2025
Last Updated
February 25, 2026
Results First Posted
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
Individual participant data that underlie published results will be made available to other researchers, after de-identification.