Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening
- Conditions
- Smoking Cessation
- Interventions
- Behavioral: Removal of Financial BarriersBehavioral: Financial IncentivesBehavioral: Mobile Health Application
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3228
- 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
- No cell phone
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced Usual Care plus Financial Incentives plus Mobile Health Application Removal of Financial Barriers 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. Enhanced Usual Care plus Financial Incentives plus Mobile Health Application Financial Incentives 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. Enhanced Usual Care plus Financial Incentives plus Mobile Health Application 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. Enhanced Usual Care Removal of Financial Barriers 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. Enhanced Usual Care plus Financial Incentives Removal of Financial Barriers 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. Enhanced Usual Care plus Financial Incentives 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.
- 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)
Lancaster General Health
🇺🇸Lancaster, Pennsylvania, United States
Kaiser Permanente Southern California
🇺🇸Oakland, California, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Geisinger
🇺🇸Danville, Pennsylvania, United States