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

NCT07176000 | Not Yet Recruiting

• 4 other identifiers: RG1125421NCI-2025-06016FHIRB0020813U19MD020533
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Completion of chest computed tomography (CT) (Aim 1.2)

  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.

  Up to 6 months

Secondary Outcomes (8)

• Completion of low dose computed tomography of the chest (Aim 1.2)

  Up to 21 months

• Lung cancer screening (LCS) knowledge (Aim 1.2)

  At 21 months

• Health-related quality of life (Aim 1.2)

  At 21 months

• Rate of reported 30-day cessation period (Aim 1.2)

  Up to 6 months

• Completion of chest CT (Aim 2)

  Up to 6 months

Study Arms (2)

Arm 1 (tailored PN)

EXPERIMENTAL

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.

Behavioral: Patient Navigation; Other: Educational Intervention; Other: Interview; Other: Survey Administration; Other: Electronic Health Record Review

Arm 2 (enhanced usual care, delayed tailored PN)

ACTIVE COMPARATOR

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

Behavioral: Patient Navigation; Other: Best Practice; Other: Interview; Other: Survey Administration; Other: Electronic Health Record Review

Interventions

Interview OTHER

Ancillary studies

Arm 1 (tailored PN); Arm 2 (enhanced usual care, delayed tailored PN)

Survey Administration OTHER

Ancillary studies

Arm 1 (tailored PN); Arm 2 (enhanced usual care, delayed tailored PN)

Electronic Health Record Review OTHER

Ancillary studies

Arm 1 (tailored PN); Arm 2 (enhanced usual care, delayed tailored PN)

Educational Intervention OTHER

Receive LCS educational handout

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm 1 (tailored PN)

Best Practice OTHER

Receive enhanced usual care

Also known as: standard of care, standard therapy

Arm 2 (enhanced usual care, delayed tailored PN)

Patient Navigation BEHAVIORAL

Receive tailored PN activities

Also known as: Patient Navigator Program

Arm 1 (tailored PN); Arm 2 (enhanced usual care, delayed tailored PN)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

Muckleshoot Tribal Clinic

Auburn, Washington, 98092, United States

Location

South Puget Intertribal Planning Agency (SPIPA)

Shelton, Washington, 98584, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Patient Navigation; Early Intervention, Educational; Educational Status; Methods; Practice Guidelines as Topic; Standard of Care; Interviews as Topic

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Matty Triplette, MD, MPH

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matty Triplette, MD, MPH

CONTACT

(206) 667-6335; mtriplet@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Research staff and study coordinators will be blinded to study arm while patient, navigators, and providers will be aware of study arm.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 29, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 8, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)