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

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT04798664

Collaborator

Patient-Centered Outcomes Research Institute (Other)

3,200

Enrollment

Locations

Arms

42.5

Anticipated Duration (Months)

800

Patients Per Site

18.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Behavioral: Removal of Financial Barriers Behavioral: Financial Incentives Behavioral: Mobile Health Application	N/A

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 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

Anticipated Enrollment :

3200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a prospective randomized controlled trial 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.This is a prospective randomized controlled trial 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 (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 17, 2021

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Active Comparator: 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.	Behavioral: Removal of Financial Barriers Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications
Active Comparator: 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.	Behavioral: Removal of Financial Barriers Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications Behavioral: Financial Incentives Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.
Active Comparator: 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.	Behavioral: Removal of Financial Barriers Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications Behavioral: Financial Incentives Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months. Behavioral: Mobile Health Application Episodic future thinking tool to overcome temporal discounting of future

Outcome Measures

Primary Outcome Measures

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

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).
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Southern California	Oakland	California	United States	94612
2	Henry Ford Health System	Detroit	Michigan	United States	48202
3	Geisinger	Danville	Pennsylvania	United States	17822
4	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104