Recruiting

Patient Navigation

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT07176000

Conditions

Lung Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Patient Navigation

Educational Intervention

Best Practice

Interview

Survey Administration

Study Details

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

Study ID

NCT07176000

Start date

Sep 15, 2026

Status verified date

Aug, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Mar 29, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

237 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

Patient Navigation

Receive tailored PN activities

Educational Intervention

Receive LCS educational handout

Best Practice

Receive enhanced usual care

Interview

Ancillary studies

Survey Administration

Ancillary studies

Electronic Health Record Review

Ancillary studies

Primary outcome measure

  • Completion of chest computed tomography (CT) (Aim 1.2) [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Locations

Muckleshoot Tribal Clinic

Recruiting

Auburn, Washington, United States, 98092

South Puget Intertribal Planning Agency (SPIPA)

Recruiting

Shelton, Washington, United States, 98584

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-08-25.