Tailored Patient Navigation to Improve the Uptake of Lung Cancer Screening in Tribal Communities in Western Washington State, SACRED LUNGS Trial

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM 1: Participants receive tailored PN activities in support of the uptake and follow-up of LCS for 21 months. Participants also receive an educational handout on LCS on study.

ARM 2: Participants receive enhanced usual care consisting of an educational handout on LCS and a warm hand-off to discuss LCS with their primary care physician (PCP) for 6 months. Participants then receive tailored PN services in support of the uptake and follow-up of LCS for 15 months.

• Patient Navigation (Behavioral), also known as Patient Navigator Program: Receive tailored PN activities
• Educational Intervention (Other), also known as Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational: Receive LCS educational handout
• Best Practice (Other), also known as standard of care, standard therapy: Receive enhanced usual care
• Interview (Other): Ancillary studies
• Survey Administration (Other): Ancillary studies
• Electronic Health Record Review (Other): Ancillary studies

Primary outcomes

• Completion of chest computed tomography (CT) (Aim 1.2) [Up to 6 months]: Will be compared between arms using the Cochran-Mantel-Haenszel (CMH) test, accounting for the stratification variables used during randomization. Completion rates will also be estimated in each arm and 95% confidence intervals for the rates and their difference will be calculated using Wilson's score method. The single primary outcome will be tested using two-sided α = 0.05.

Secondary outcomes

• Completion of low dose computed tomography of the chest (Aim 1.2) [Up to 21 months]: Will be compared between arms using the CMH test. Will be tested using two-sided α = 0.05 without adjustment for multiplicity.
• Lung cancer screening (LCS) knowledge (Aim 1.2) [At 21 months]: Will be compared between arms using a stratified Wilcoxon rank-sum test (van Elteren test). Will be tested using two-sided α = 0.05 without adjustment for multiplicity.
• Health-related quality of life (Aim 1.2) [At 21 months]: Will be measured using the Short Form 36 Health Survey questionnaire. Will be compared between arms using a stratified Wilcoxon rank-sum test (van Elteren test). Will be tested using two-sided α = 0.05 without adjustment for multiplicity.
• Rate of reported 30-day cessation period (Aim 1.2) [Up to 6 months]: The impact of navigation on tobacco cessation will be explored by the rates of a reported 30-day cessation period during the intervention period as measured by self-reported 30-day floating abstinence.
• Completion of chest CT (Aim 2) [Up to 6 months]: Quantitative analyses will use structural equation models (SEM) to understand the relationships between measured and latent variables representing barriers, facilitators and social determinants of health and the outcome of CT completion.
• Navigation care engagement (Aim 2) [Up to 21 months]: Quantitative analyses in this aim will use SEM to understand the relationships between measured and latent variables representing barriers, facilitators and social determinants of health and the outcome of navigation care engagement. Measure of reach will be operationalized as an ordinal scale based on care completion activities along the LCS continuum as documented in the electronic health record.
• Completion of chest CT (Aim 3) [Up to 15 months]: The rate of chest CT completion during the maintenance phase in the control arm (after navigation is offered) will be estimated and compared with the rate during the trial phase (before navigation was offered) using Poisson regression with the log link. The phase (trial versus maintenance) will be modeled using a time varying covariate, where each participant will contribute an outcome for each phase in which they are still "at risk" for completing CT (i.e., until first CT completion or end of follow-up). Models will include additional key covariates, including clinical site, smoking status, and prior reported LCS. Generalized estimating equations will be used to account for multiple periods per participant and potential overdispersion.
• Completion of next diagnostic step in LCS follow-up [Up to 15 months]: Adherence to follow-up will be assessed as binary completion of the next step in follow-up among those with a completed chest CT during the randomized controlled trial. Appropriate next step in follow-up is determined through the Lung CT Screening Reporting and Data System (Lung-RADS) system, with most participants having negative initial CT (Lung-RADS 1 or 2) with follow-up assessed at 11-15 months. Adherence rates will be estimated as a proportion with 95% confidence intervals, summarized overall and stratified by Lung-RADS.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Between ages 50-77
* AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Self-reported 20-pack year smoking history
* AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Ongoing commercial tobacco use within the past 15 years
* AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Seen by a PCP at a participating clinic (South Puget Intertribal Planning Agency \[SPIPA\] or Muckleshoot) within the past three years

  * Potential participants who want to establish care at an eligible clinic will be connected to a PCP
* AIM 2 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: At least 18 years of age
* AIM 2 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Affiliation with Muckleshoot or SPIPA (one of the 6 community partnering clinics) as a provider, or supportive staff member
* AIM 2 PATIENT SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Patient participated in the aim 1.2 trial
* AIM 3 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: At least 18 years of age
* AIM 3 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Affiliation with Muckleshoot or SPIPA (one of the 6 community partnering clinics) as a provider, or supportive staff member
* AIM 3 PATIENT SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Patient participated in the aim 1.2 trial

Exclusion Criteria:

* AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Has had a documented chest CT within the past one year
* AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Personal history of lung cancer
* AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Personal history of any cancer within 5 years except for basal cell or squamous cell skin carcinoma

• Results publication: Triplette M, Walsh C, Shah PD, Hippe DS, Louie T, Anderson N, Long S, Omernik B, Schwartz J, Nelson L, Parker M, Mendoza JA, Nikander J, Ramachandran M, Carey A, Tsosie U. 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. Contemp Clin Trials. 2026 Sep;168:108408. doi: 10.1016/j.cct.2026.108408. Epub 2026 Jul 20. PMID 42476254

• Matty Triplette, MD, MPH, Principal investigator, Fred Hutch/University of Washington Cancer Consortium

NIH grants: U19MD020533