Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 3,228
- Locations
- 5
- Primary Endpoint
- Biochemically Confirmed Smoking Abstinence Sustained for 6 Months
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
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.
Intervention: Removal of Financial Barriers (Behavioral)
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.
Intervention: Removal of Financial Barriers (Behavioral)
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.
Intervention: Financial Incentives (Behavioral)
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.
Intervention: Removal of Financial Barriers (Behavioral)
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.
Intervention: Financial Incentives (Behavioral)
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.
Intervention: Mobile Health Application (Behavioral)
Outcomes
Primary Outcomes
Biochemically Confirmed Smoking Abstinence Sustained for 6 Months
Time Frame: 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 Outcomes
- 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)
- Motivation to Quit(6 months)
- Temporal ("Delay") Discounting(Baseline)
- Health-related Quality of Life(6 months)
- Perceived Barriers to Cessation(6 months)
- Self-efficacy Related to Cessation Efforts(6 months)
- Temporal ("Delay") Discounting(6 months)
- Health-related Quality of Life(12 months)
- Perceived Barriers to Cessation(12 months)
- Self-efficacy Related to Cessation Efforts(12 months)
- Motivation to Quit(12 months)
- Temporal ("Delay") Discounting(12 months)
- Self-report Cigarette Abstinence(2 weeks, 3 months, 6 months, 12 months)
- Self-report Other Tobacco Abstinence(2 weeks, 3 months, 6 months, 12 months)