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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Patient Navigation

    Behavioral

    Receive tailored PN activities

  • Educational Intervention

    Other intervention

    Receive LCS educational handout

  • Best Practice

    Other intervention

    Receive enhanced usual care

  • Interview

    Other intervention

    Ancillary studies

  • Survey Administration

    Other intervention

    Ancillary studies

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

Treatment groups

237 Participants
are divided into 2 treatment groups
Group A: Arm 1 (tailored PN)Experimental treatment 5 interventions
Group B: Arm 2 (enhanced usual care, delayed tailored PN)Active comparator 5 interventions

Trial outcomes

Primary outcomes

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.

Time frame
Up to 6 months

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Up to 6 months

Other outcomes

Sponsors and contacts

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Fred Hutchinson Cancer Center

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator