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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Screening
Masking
Single (Investigator)
Masking Description
Research staff and study coordinators will be blinded to study arm while patient, navigators, and providers will be aware of study arm.

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Behavioral: Patient Navigation
    Receive tailored PN activities
    Other names:
    • Patient Navigator Program
  • Other: Educational Intervention
    Receive LCS educational handout
    Other names:
    • Education for Intervention
    • Intervention by Education
    • Intervention through Education
    • Intervention, Educational
  • Other: Interview
    Ancillary studies
  • Other: Survey Administration
    Ancillary studies
  • Other: Electronic Health Record Review
    Ancillary studies
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.
  • Behavioral: Patient Navigation
    Receive tailored PN activities
    Other names:
    • Patient Navigator Program
  • Other: Best Practice
    Receive enhanced usual care
    Other names:
    • standard of care
    • standard therapy
  • Other: Interview
    Ancillary studies
  • Other: Survey Administration
    Ancillary studies
  • Other: Electronic Health Record Review
    Ancillary studies

Recruiting Locations

Muckleshoot Tribal Clinic
Auburn, Washington 98092

South Puget Intertribal Planning Agency (SPIPA)
Shelton, Washington 98584

More Details

Status
Recruiting
Sponsor
Fred Hutchinson Cancer Center

Study Contact

Matty Triplette, MD, MPH
(206) 667-6335
mtriplet@fredhutch.org

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.