Clinical trial NCT04798664: Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening
Official title: Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: Patients, Underserved
Early Detection of Cancer
Lung Cancer
Nicotine Replacement Products
Incentives
Behavioral Economics
Smoking Cessation
Nicotine Dependence
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2021-03-15
Enrollment: 3228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biochemically confirmed smoking abstinence sustained for 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Quit status (self-report)
timeFrame: 2 weeks, 3 months, 6 months, 12 months
measure: Quit status (biochemically confirmed)
timeFrame: 2 weeks, 3 months, 6 months,12 months
measure: Health-related quality of life
timeFrame: Baseline, 6 months, 12 months
measure: Perceived barriers to cessation
timeFrame: Baseline, 6 months, 12 months
measure: Self-efficacy related to cessation efforts
timeFrame: Baseline, 6 months, 12 months
measure: Motivation to quit
timeFrame: Baseline, 6 months, 12 months
measure: Temporal ("delay") discounting
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Southern California
state: California
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Scott D Halpern, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kohn R, Vachani A, Small D, Stephens-Shields AJ, Sheu D, Madden VL, Bayes BA, Chowdhury M, Friday S, Kim J, Gould MK, Ismail MH, Creekmur B, Facktor MA, Collins C, Blessing KK, Neslund-Dudas CM, Simoff MJ, Alleman ER, Epstein LH, Horst MA, Scott ME, Volpp KG, Halpern SD, Hart JL; Stakeholder Advisory Committee. Comparing Smoking Cessation Interventions among Underserved Patients Referred for Lung Cancer Screening: A Pragmatic Trial Protocol. Ann Am Thorac Soc. 2022 Feb;19(2):303-314. doi: 10.1513/AnnalsATS.202104-499SD.