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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04798664
• Other study ID #: PCS-2018C1-11326
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: July 1, 2025

Study information

• Verified date: October 2023
• Source: University of Pennsylvania
• Contact: Shira Blady, BS
• Phone: 215-573-3085
• Email: bladysh[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: July 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Smoking Cessation

Intervention

Behavioral:
• Removal of Financial Barriers
Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications
• Financial Incentives
Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.
• Mobile Health Application
Episodic future thinking tool to overcome temporal discounting of future

Locations

Country	Name	City	State
United States	Geisinger	Danville	Pennsylvania
United States	Henry Ford Health System	Detroit	Michigan
United States	Kaiser Permanente Southern California	Oakland	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quit status (self-report)	Point-prevalent rates of self-reported nicotine use and tobacco product use	2 weeks, 3 months, 6 months, 12 months
Secondary	Quit status (biochemically confirmed)	Point-prevalent rates of biochemically confirmed smoking cessation	2 weeks, 3 months, 6 months,12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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