Patient navigation for lung cancer screening in an urban safety-net system: Protocol for a pragmatic randomized clinical trial

Abstract

The National Lung Screening Trial demonstrated improved lung cancer mortality with annual low-dose computed tomography (CT) screening, leading to lung cancer screening endorsement by the United States Preventive Services Task Force and coverage by the Centers for Medicare and Medicaid. Adherence to annual CT screens in that trial was 95%, which may not be representative of real-world, particularly medically underserved populations. This pragmatic trial will determine the effect of patient-focused, telephone-based patient navigation on adherence to CT-based lung cancer screening in an urban safety-net population. 340 adults who meet standard eligibility for lung cancer screening (age 55-77years, smoking history≥30 pack-years, quit within 15years if former smoker) are referred through an electronic medical record-based order by physicians in community- and hospital-based primary care settings within the Parkland Health and Hospital System in Dallas County, Texas. Eligible patients are randomized to usual care or patient navigation, which addresses adherence, patient-reported barriers, smoking cessation, and psycho-social concerns related to screening completion. Patients complete surveys and semi-structured interviews at baseline, 6-month, and 18-month follow-ups to assess attitudes toward screening. The primary endpoint of this pragmatic trial is adherence to three sequential, prospectively defined steps in the screening protocol. Secondary endpoints include self-reported tobacco use and other patient-reported outcomes. Results will provide real-world insight into the impact of patient navigation on adherence to CT-based lung cancer screening in a medically underserved population. This study was registered with the NIH ClinicalTrials.gov database (NCT02758054) on April 26, 2016.

Keywords: Adherence; Lung cancer screening; Navigation; Patient reported outcomes; Pragmatic trial; Smoking cessation.

Fig. 1.

Project algorithm. Follow-up surveys will be performed 6 months and 18 months after baseline survey. Depending on clinical findings and events, these may capture the 1st and 2nd CT screen, respectively, or multiple other clinical steps (such as other radiology studies, biopsies, etc.).

Fig. 2.

Screening algorithm and endpoint schema. Steps 1, 2, and 3 may occur over varying time-frames: normal/low suspicion scans will be repeated annually; interval scans to evaluate indeterminate CT scans will be performed at intervals < 12 months; subsequent steps to evaluate high suspicion CT scans are anticipated to occur within weeks of the CT scan. Characterization of suspicion (low, indeterminate, or high) reflects the size, imaging features (e.g., spiculated, calcified), and rate of change of nodules. Follow-up of abnormal CT scans (e.g., biopsy or PET-CT) will be determined by local test availability and practice patterns, such as Fleischner Guidelines or Lung-RADS.