Trial Summary

Lung cancer is the leading cause of cancer-related mortality in the United States, accounting for approximately 1 in 5 cancer-related deaths. Approximately 80% of lung cancers are attributable to cigarette smoking. Annual low-dose computed tomography screening for lung cancer (hereafter referred to as "lung cancer screening") is recommended by the US Preventive Services Task Force (USPSTF). Despite evidence of effectiveness and the USPSTF recommendations, implementation of lung cancer screening into clinical practice has been exceedingly limited, with only 6.5% of eligible individuals screened in 2020, and there are major health inequities in lung cancer screening related to race/ethnicity and socioeconomic status. The long-term goal of this program of research is to increase the reach of lung cancer screening at scale among low-resource healthcare settings and populations that have been historically marginalized. LungSMART is a 2-phase, sequential multiple-assignment randomized trial (SMART) conducted in community health centers in Utah. Utah has 14 community health center systems with approximately 50 primary care clinics. Each of the Utah community health centers is a federally qualified health center providing comprehensive primary care to more than 160,000 patients annually. Patients in Utah community health centers are 52% Latino, 8% Native American, 40% best served in a language other than English, 55% below the federal poverty level, and 43% uninsured, and 41% of the clinics are in rural areas (Rural-Urban Continuum Code greater than 4). LungSMART is guided by a comprehensive conceptual framework and is designed to directly address lung cancer screening implementation challenges to ensure equitable implementation and reduce health inequities. LungSMART uses a population health management framework in which scalable, accessible, and sustainable telehealth interventions are used to engage patients in lung cancer screening. Phase 1 of LungSMART leverages ubiquitous technologies to enable patients to be assessed for lung cancer screening eligibility, engage in shared decision-making if eligible, and be referred for lung cancer screening. Phase 2 of LungSMART tests telehealth interventions designed to address logistical barriers and hesitancy around completing lung cancer screening among referred patients. LungSMART leverages smartphone/internet technologies when available, and also supports patients whose only telehealth connectivity is a cellphone. A centralized "hub” enables eligibility assessment, shared decision-making with clinical decision support, screening referral, and screening logistics assistance at scale to help overcome numerous social determinants of health that affect low-resource settings and historically marginalized populations. All study procedures and interventions will be conducted in English or Spanish based on the patient’s preferred language. In sum, LungSMART will be conducted in a real-world context across multiple independent healthcare delivery systems with limited resources and among historically marginalized populations. LungSMART will provide a critical evidence base for the large-scale implementation of interventions designed to reduce health inequities in lung cancer screening in community health centers and other low-resource settings nationwide.

NIH Project Information