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Lung CarcinomaNCT07176000

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

A study testing Patient Navigation, Educational Intervention and Best Practice in people with Lung Carcinoma, run by Fred Hutchinson Cancer Center at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Lung Carcinoma
What is being tested?
Patient Navigation, Educational Intervention and Best Practice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
237 participants
Where
2 sitesUnited States
Study dates
1 Oct 2026to 30 Apr 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Matty Triplette, MD, MPH contact

(206) 667-6335

mtriplet@fredhutch.org

United States2 sites, 2 recruiting

  • Muckleshoot Tribal Clinic

    Auburn, Washington, 98092

    Recruiting

  • South Puget Intertribal Planning Agency (SPIPA)

    Shelton, Washington, 98584

    Recruiting

Other trials in United States

About this study

Official title: Strengthening Awareness and Community Resources for Early Detection of Lung Cancer Through Navigation Guided Screening Trial (SACRED LUNGS Aims 1.2-3)

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.

Read the 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.

Conditions
Lung Carcinoma
Being tested
Patient Navigation, Educational Intervention, Best Practice, Interview, Survey Administration
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient NavigationBehavioural

    Also called Patient Navigator Program

    Receive tailored PN activities

  • Educational InterventionOther

    Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

    Receive LCS educational handout

  • Best PracticeOther

    Also called standard of care, standard therapy

    Receive enhanced usual care

  • InterviewOther

    Ancillary studies

  • Survey AdministrationOther

    Ancillary studies

  • Electronic Health Record ReviewOther

    Ancillary studies

Study groups in NCT07176000
Study groupRoleWhat they receive
Arm 1 (tailored PN)ExperimentalParticipants 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.
Receives: 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 comparatorParticipants 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.
Receives: Behavioral: Patient Navigation; Other: Best Practice; Other: Interview; Other: Survey Administration; Other: Electronic Health Record Review

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 6 months

Secondary outcomes (8)

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

    Will be compared between arms using the CMH test. Will be tested using two-sided α = 0.05 without adjustment for multiplicity.

    Measured: Up to 21 months

  2. Lung cancer screening (LCS) knowledge (Aim 1.2)

    Will be compared between arms using a stratified Wilcoxon rank-sum test (van Elteren test). Will be tested using two-sided α = 0.05 without adjustment for multiplicity.

    Measured: At 21 months

  3. Health-related quality of life (Aim 1.2)

    Will be measured using the Short Form 36 Health Survey questionnaire. Will be compared between arms using a stratified Wilcoxon rank-sum test (van Elteren test). Will be tested using two-sided α = 0.05 without adjustment for multiplicity.

    Measured: At 21 months

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

    The impact of navigation on tobacco cessation will be explored by the rates of a reported 30-day cessation period during the intervention period as measured by self-reported 30-day floating abstinence.

    Measured: Up to 6 months

  5. Completion of chest CT (Aim 2)

    Quantitative analyses will use structural equation models (SEM) to understand the relationships between measured and latent variables representing barriers, facilitators and social determinants of health and the outcome of CT completion.

    Measured: Up to 6 months

  6. Navigation care engagement (Aim 2)

    Quantitative analyses in this aim will use SEM to understand the relationships between measured and latent variables representing barriers, facilitators and social determinants of health and the outcome of navigation care engagement. Measure of reach will be operationalized as an ordinal scale based on care completion activities along the LCS continuum as documented in the electronic health record.

    Measured: Up to 21 months

  7. Completion of chest CT (Aim 3)

    The rate of chest CT completion during the maintenance phase in the control arm (after navigation is offered) will be estimated and compared with the rate during the trial phase (before navigation was offered) using Poisson regression with the log link. The phase (trial versus maintenance) will be modeled using a time varying covariate, where each participant will contribute an outcome for each phase in which they are still "at risk" for completing CT (i.e., until first CT completion or end of follow-up). Models will include additional key covariates, including clinical site, smoking status, and prior reported LCS. Generalized estimating equations will be used to account for multiple periods per participant and potential overdispersion.

    Measured: Up to 15 months

  8. Completion of next diagnostic step in LCS follow-up

    Adherence to follow-up will be assessed as binary completion of the next step in follow-up among those with a completed chest CT during the randomized controlled trial. Appropriate next step in follow-up is determined through the Lung CT Screening Reporting and Data System (Lung-RADS) system, with most participants having negative initial CT (Lung-RADS 1 or 2) with follow-up assessed at 11-15 months. Adherence rates will be estimated as a proportion with 95% confidence intervals, summarized overall and stratified by Lung-RADS.

    Measured: Up to 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start1 Oct 2026
  3. Primary completion29 Mar 2029 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
237 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07176000
Sponsor's protocol ID
RG1125421
Other IDs
NCI-2025-06016, FHIRB0020813, U19MD020533
Status last verified
Aug 2026
First submitted
9 Sep 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Triplette M, Walsh C, Shah PD, Hippe DS, Louie T, Anderson N, Long S, Omernik B, Schwartz J, Nelson L, Parker M, Mendoza JA, Nikander J, Ramachandran M, Carey A, Tsosie U. Strengthening awareness and community resources for early detection of lung cancer through navigation guided screening in American Indian/Alaska Native clinics (SACRED LUNGS): Study protocol. Contemp Clin Trials. 2026 Sep;168:108408. doi: 10.1016/j.cct.2026.108408. Epub 2026 Jul 20.

    PubMed 42476254

Questions about this trial

What is this clinical trial studying?

A study testing Patient Navigation, Educational Intervention and Best Practice in people with Lung Carcinoma, run by Fred Hutchinson Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Matty Triplette, MD, MPH ((206) 667-6335, mtriplet@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion of chest computed tomography (CT) (Aim 1.2) (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07176000, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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