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

Fred Hutchinson Cancer Center (FHCC)

Status: Begins enrollment this month

Conditions: Lung Carcinoma

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07176000

U19MD020533 (U.S. NIH Grant/Contract)

RG1125421

FHIRB0020813 (Other Identifier)

NCI-2025-06016 (Registry Identifier)

Details and patient eligibility

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. 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.

Full description

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.

Enrollment: 237 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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237 participants in 2 patient groups

Arm 1 (tailored PN)

Experimental group

Description:

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.

Treatment:

Other: Electronic Health Record Review

Behavioral: Patient Navigation

Other: Survey Administration

Other: Interview

Other: Educational Intervention

Arm 2 (enhanced usual care, delayed tailored PN)

Active Comparator group

Description:

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.

Treatment:

Other: Electronic Health Record Review

Behavioral: Patient Navigation

Other: Survey Administration

Other: Interview

Other: Best Practice