Brief Summary

Lung cancer is the leading cause of cancer mortality among American Indians and Alaska Natives (AI/AN), and AI/AN have worse lung cancer incidence rates, survival, and death compared to the general population. Because lung cancer screening (LCS) with low-dose computed tomography (LDCT) has been shown to reduce lung cancer mortality by roughly 20%, the United States Preventive Services Task Force now recommends LCS for men and women aged 55-80 years who meet specific eligibility criteria (grade-B evidence), and subsequently the Center for Medicare and Medicaid Services (CMS) opted to cover this test. However, the uptake of LCS implementation has been slow in most healthcare systems, and LCS implementation among AI/AN has never been studied. To address this knowledge, we prose the "Tribally Engaged Approaches to Lung Screening (TEALS)" study, which is a collaborative effort between the Choctaw Nation of Oklahoma, the Stephenson Cancer Center, and the University of Oklahoma Health Sciences Center. Over the course of 5 years, TEALS will:

1.Conduct focus groups and semi-structured interviews with CNHSA patients, clinicians, and health administrators to elucidate individual- and system-level barriers and facilitators that affect the implementation of LCS;
2.Develop an LCS care coordination intervention that will identify eligible persons for LCS, help these patients navigate the screening process, and link them with smoking cessation services, when applicable;
3.Measure the impact of the TEALS intervention on the receipt of screening and a set of patient- and practice-level outcomes by conducting a cluster-randomized clinical trial of LCS implementation; and
4.Disseminate the TEALS program to other researchers and healthcare systems that serve AI/AN patients. TEALS will bridge the gap between evidence and clinical practice for LCS in a high-need, low-resource setting by intervening at the level of the healthcare system.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

275

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline

7mo left

Started Jan 2022

Longer than P75 for not_applicable lung-cancer

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.9 years study duration

Study Progress89%

Jan 2022Dec 2026

First Submitted

Initial submission to the registry

April 26, 2021

Completed

2 months until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed

6 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2023

Completed

3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

April 26, 2021

Last Update Submit

March 26, 2026

Conditions

Lung Cancer

Keywords

lung cancerscreeningearly detection and treatmentprimary careimplementationcommunity-engaged researchNative Americanstribal health

Outcome Measures

Primary Outcomes (9)

1. Uptake of low-dose computed tomography lung cancer screening services
Receiving lung cancer screening (LCS) when eligible
12 months
2. Uptake of low-dose computed tomography lung cancer screening services
Participating in a care planning visit with the lung-cancer screening coordinator (LCC) before screening and a follow-up visit, if screened positive
12 months
3. Uptake of low-dose computed tomography lung cancer screening services
Receipt of follow-up treatment when clinically recommended
12 months
4. Uptake of low-dose computed tomography lung cancer screening services
Receipt of smoking cessation intervention at any point of the LCS process.
12 months
1. Health system-level care process outcomes
A RE-AIM framework will be utilized. Reach of the screening program will be measured by the proportion of LCS-eligible patients who were contacted by the screening coordinator
12 months
2. Health system-level care process outcomes
A RE-AIM framework will be utilized. Effectiveness will be measured by the proportion of eligible patients who have completed the screening and treatment process according to their particular needs
12 months
3. Health system-level care process outcomes
A RE-AIM framework will be utilized. Adoption will be measured by the proportion of individual clinician practices in the Choctaw Nation healthcare system that implemented the program.
12 months
4. Health system-level care process intervention outcomes % of patients with LCS
A RE-AIM framework will be utilized. Implementation will be measured as the fidelity to the steps of the pre-determined LCS process in each practice
12 months
5. Health system-level care process improvement outcomes
A RE-AIM framework will be utilized. Maintenance will be measured as the time of sustaining each LCS implementation key component at the practice and system level.
12 months

Secondary Outcomes (13)

Patient and health system-level scales
12 months
CAHPS
12 months
PAM
12 months
CPCQ
12 months
ACIC
12 months
+8 more secondary outcomes

Study Arms (7)

Control 1-1

EXPERIMENTAL

Patients and clinicians in control practices will receive usual Electronic Health Record (EHR) reminders for lung cancer screening (LCS).