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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Patient Navigation
BehavioralReceive tailored PN activities
Educational Intervention
Other interventionReceive LCS educational handout
Best Practice
Other interventionReceive enhanced usual care
Interview
Other interventionAncillary studies
Survey Administration
Other interventionAncillary studies
Electronic Health Record Review
Other interventionAncillary studies
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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Fred Hutchinson Cancer Center
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator