NCT07176000 · Fred Hutchinson Cancer Center
Tailored Patient Navigation to Improve the Uptake of Lung Cancer Screening in Tribal Communities in Western Washington State, SACRED LUNGS Trial
What this study is about
This clinical trial studies whether tailored patient navigation (PN) works to improve the uptake of lung cancer screening (LCS) in tribal communities in western Washington state.
View original scientific description
This clinical trial studies whether tailored patient navigation (PN) works to improve the uptake of lung cancer screening (LCS) in tribal communities in western Washington state. Lung cancer is the leading cause of cancer death in the United States among American Indian (AI) and Alaska Native (AN) people, and the incidence of lung cancer is higher in this population in the Northern and Southern Plains, Alaska, and Pacific Coast regions. In Washington state, AI/AN people also have twice the rate of commercial cigarette smoking than the overall population. LCS with annual low-dose chest computed tomography (CT) can reduce lung cancer death and is recommended in people 50-80 years of age with current or recent (within 15 years) tobacco use and a 20 pack-year or greater smoking history. Despite this, AI and AN people are less likely to receive LCS which may be due to barriers they face making it difficult to receive LCS. PN services are designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The PN services in this trial have been tailored for the tribal communities in western Washington state. The services are designed to help participants overcome the unique barriers that their tribal communities face and improve the uptake of LCS.
Interventions
BEHAVIORAL
Patient Navigation
Receive tailored PN activities
OTHER
Educational Intervention
Receive LCS educational handout
OTHER
Best Practice
Receive enhanced usual care
OTHER
Interview
Ancillary studies
OTHER
Survey Administration
Ancillary studies
OTHER
Electronic Health Record Review
Ancillary studies
Primary outcome measures
Completion of chest computed tomography (CT) (Aim 1.2)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 or symptoms associated with lung cancer
Where
- Auburn, Washington
- Shelton, Washington
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 25, 2026 · Source of record for eligibility and locations