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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Removal of Financial Barriers
* Behavioral: Financial Incentives
* Behavioral: Mobile Health Application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective randomized controlled trial using opt-out consent with longitudinal follow-up of patients over 12 months. Based on the expected accrual at each of the four health systems, we expect that overall there will be 470 participants in basic usual care (Arm 1), and 910 participants in each of intervention arms 2-4.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Basic Usual Care<br>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<br>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<br>* Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications<br>|
| Active Comparator: Enhanced Usual Care plus Financial Incentives<br>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<br>* Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications<br>Behavioral: Financial Incentives<br>* Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.<br>|
| Active Comparator: Enhanced Usual Care plus Financial Incentives plus Mobile Health Application<br>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<br>* Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications<br>Behavioral: Financial Incentives<br>* Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.<br>Behavioral: Mobile Health Application<br>* Episodic future thinking tool to overcome temporal discounting of future<br>|

What is the study measuring?
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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 (self-report) | Point-prevalent rates of self-reported nicotine use and tobacco product use | 2 weeks, 3 months, 6 months, 12 months | 
| Quit status (biochemically confirmed) | Point-prevalent rates of biochemically confirmed smoking cessation | 2 weeks, 3 months, 6 months,12 months | 
| Health-related quality of life | 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. | Baseline, 6 months, 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) and extrinsic factors (social or environmental aspects of quitting). | Baseline, 6 months, 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. | Baseline, 6 months, 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. | Baseline, 6 months, 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. | Baseline, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients, Underserved, Early Detection of Cancer, Lung Cancer, Nicotine Replacement Products, Incentives, Behavioral Economics, Smoking Cessation, Nicotine Dependence