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

NCT ID: NCT07176000

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2029-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators
Research staff and study coordinators will be blinded to study arm while patient, navigators, and providers will be aware of study arm.

Study Groups

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Arm 1 (tailored PN)

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.

Group Type EXPERIMENTAL

Patient Navigation

Intervention Type BEHAVIORAL

Receive tailored PN activities

Educational Intervention

Intervention Type OTHER

Receive LCS educational handout

Interview

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Arm 2 (enhanced usual care, delayed tailored PN)

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.

Group Type ACTIVE_COMPARATOR

Patient Navigation

Intervention Type BEHAVIORAL

Receive tailored PN activities

Best Practice

Intervention Type OTHER

Receive enhanced usual care

Interview

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Interventions

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Patient Navigation

Receive tailored PN activities

Intervention Type BEHAVIORAL

Educational Intervention

Receive LCS educational handout

Intervention Type OTHER

Best Practice

Receive enhanced usual care

Intervention Type OTHER

Interview

Ancillary studies

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Patient Navigator Program Education for Intervention Intervention by Education Intervention through Education Intervention, Educational standard of care standard therapy

Eligibility Criteria

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Inclusion Criteria

* AIM 1 RANDOMIZED CONTROLLED TRIAL: Between ages 50-77
* AIM 1 RANDOMIZED CONTROLLED TRIAL: Self-reported 20-pack year smoking history
* AIM 1 RANDOMIZED CONTROLLED TRIAL: Ongoing commercial tobacco use within the past 15 years
* AIM 1 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 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 trial

Exclusion Criteria

* AIM 1 RANDOMIZED CONTROLLED TRIAL: Has had a documented chest CT within the past one year
* AIM 1 RANDOMIZED CONTROLLED TRIAL: Personal history of lung cancer or symptoms associated with lung cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matty Triplette, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Muckleshoot Tribal Clinic

Auburn, Washington, United States

Site Status

South Puget Intertribal Planning Agency (SPIPA)

Shelton, Washington, United States

Site Status

Countries

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United States

Central Contacts

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Matty Triplette, MD, MPH

Role: CONTACT

Phone: (206) 667-6335

Email: [email protected]

Other Identifiers

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NCI-2025-06016

Identifier Type: REGISTRY

Identifier Source: secondary_id

FHIRB0020813

Identifier Type: OTHER

Identifier Source: secondary_id

U19MD020533

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RG1125421

Identifier Type: -

Identifier Source: org_study_id