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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-17

Study Completion Date

2025-04-29

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.

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Removal of Financial Barriers

Intervention Type BEHAVIORAL

Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications

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.

Group Type ACTIVE_COMPARATOR

Removal of Financial Barriers

Intervention Type BEHAVIORAL

Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications

Financial Incentives

Intervention Type BEHAVIORAL

Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.

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.

Group Type ACTIVE_COMPARATOR

Removal of Financial Barriers

Intervention Type BEHAVIORAL

Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications

Financial Incentives

Intervention Type BEHAVIORAL

Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.

Mobile Health Application

Intervention Type BEHAVIORAL

Episodic future thinking tool to overcome temporal discounting of future

Interventions

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Removal of Financial Barriers

Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications

Intervention Type BEHAVIORAL

Financial Incentives

Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.

Intervention Type BEHAVIORAL

Mobile Health Application

Episodic future thinking tool to overcome temporal discounting of future

Intervention Type BEHAVIORAL

Other Intervention Names

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NRT Incentives FutureMe

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