Strengthening awareness and community resources for early detection of lung cancer through navigation guided screening in American Indian/Alaska Native clinics (SACRED LUNGS): Study protocol.

BACKGROUND

Lung cancer remains the leading cause of cancer death in the United States. Annual lung cancer screening (LCS) with low-dose chest CT (LDCT) can prevent lung cancer deaths in individuals at high risk, and American Indian/Alaska Native (AI/AN) adults are among the highest risk populations; however, evidence suggests lower uptake of screening in this population compared to other groups.

OBJECTIVE

To evaluate the impact of a culturally adapted patient navigation intervention delivered in Tribal healthcare clinics on LCS uptake in a randomized controlled trial (RCT) with assessment of intervention implementation and sustainability.

METHODS

This is a type 1 hybrid implementation-effectiveness trial including a patient-level RCT to test the effectiveness of a previously developed and AI/AN-tailored form of patient navigation to support LCS care completion, deployed in Tribal health clinics in Washington state. Two hundred eligible participants across 5 clinics serving 5 Tribes will be randomized 1:1 to patient navigation or enhanced usual care. The primary outcome will be completion of a chest CT within 6 months of randomization, with secondary outcomes evaluating impact of navigation of health-related quality of life and smoking cessation. After the RCT phase, both trial arms will have access to patient navigation for an additional 15 months to allow an implementation evaluation focused on both the determinants of LCS care completion and the sustainability of the patient navigation intervention in Tribal clinic settings.

DISCUSSION: Patient navigation may improve LCS uptake and be both an effective and sustainable model in Tribal clinic settings to improve LCS care completion in AI/AN adults who are eligible.

REGISTRATION: ClinicalTrials.gov ID NCT07176000.