Tribally Engaged Approaches to Lung Screening (TEALS)

Tribally Engaged Lung Screening Trial (TEALS)

NCT: NCT04948060 · Status: ACTIVE NOT RECRUITING · Phase: N/A · Sponsor: University of Oklahoma · Started: 2022-01-01 · Est. Completion: 2026-12

Plain English Summary

Tribally Engaged Approaches to Lung Screening (TEALS) is a Not Applicable clinical trial sponsored by University of Oklahoma studying Lung Cancer. This trial tests a new approach to lung cancer screening for American Indians and Alaska Natives. It is for adults aged 50-80 who have a history of smoking. Participation involves receiving enhanced lung cancer screening services and potentially smoking cessation support. Alternatives include standard lung cancer screening guidelines if available. The trial aims to enroll 275 participants.

Official 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. System-level interventions for guideline imp

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 50 and 80 years old. You must have smoked for at least 30 pack-years (e.g., a pack a day for 30 years). You must currently smoke or have quit within the last 15 years. You cannot join if you are unwilling to undergo screening, follow-up testing, or treatment if needed, or if your doctor believes screening would not benefit you. This trial is studying Lung Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The main goal is to see if the new screening approach increases the number of eligible individuals receiving low-dose CT scans for lung cancer. The specific primary outcome measures are: 1. Uptake of low-dose computed tomography lung cancer screening services (12 months); 2. Uptake of low-dose computed tomography lung cancer screening services (12 months); 3. Uptake of low-dose computed tomography lung cancer screening services (12 months); 4. Uptake of low-dose computed tomography lung cancer screening services (12 months); 1. Health system-level care process outcomes (12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial addresses the critical gap in lung cancer screening for American Indians and Alaska Natives, who face higher mortality rates from the disease. This research targets Lung Cancer, where improved treatment options are needed.

Investor Insight

This trial focuses on a specific, underserved population, aiming to improve screening uptake and potentially reduce lung cancer deaths, which could signal a need for culturally tailored healthcare int

Is This Trial Right for Me?

Ask your doctor if you are eligible and if this screening is right for you. Understand that participation may involve regular screening appointments and follow-up tests if needed. The study aims to make screening easier and more accessible within your community. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* adults aged 50-80
* 30 pack-year smoking history
* currently smoke or quit in the past 15 years.

Exclusion Criteria:

* Those who are not willing to be screened or followed up with diagnostic testing or intervention, if positive.
* Those who are otherwise designated by their primary care doctors as not able to benefit from screening.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT04948060?

NCT04948060 is a Not Applicable INTERVENTIONAL study titled "Tribally Engaged Approaches to Lung Screening (TEALS)." It is currently active, not recruiting and is sponsored by University of Oklahoma. The trial targets enrollment of 275 participants.

What conditions does NCT04948060 study?

This trial investigates treatments for Lung Cancer. The primary condition under study is Lung Cancer.

What treatments are being tested in NCT04948060?

The interventions being studied include: Enhanced lung cancer screening services (OTHER). A theoretically sound and evidence-based, multi-component implementation strategy will be applied which includes care quality benchmarking and regular performance feedback, academic detailing provided by specially trained primary care clinicians, practice facilitation provided by trained and certified Practice Facilitators (PFs), health information technology (HIT) support, and facilitated professional networking to promote the cross-pollination and rapid dissemination of solutions and best prac

What does Not Applicable mean for NCT04948060?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT04948060?

This trial is currently "Active, Not Recruiting." It started on 2022-01-01. The estimated completion date is 2026-12.

Who is sponsoring NCT04948060?

NCT04948060 is sponsored by University of Oklahoma. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT04948060?

The trial aims to enroll 275 participants. The trial status is active, not recruiting.

How is NCT04948060 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT04948060?

The primary outcome measures are: 1. Uptake of low-dose computed tomography lung cancer screening services (12 months); 2. Uptake of low-dose computed tomography lung cancer screening services (12 months); 3. Uptake of low-dose computed tomography lung cancer screening services (12 months); 4. Uptake of low-dose computed tomography lung cancer screening services (12 months); 1. Health system-level care process outcomes (12 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT04948060 being conducted?

This trial is being conducted at 1 site, including Oklahoma City, Oklahoma (United States).

Where can I find official information about NCT04948060?

The official record for NCT04948060 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04948060. This government database provides the most up-to-date and detailed information about the trial.

What is NCT04948060 testing in simple terms?

This trial tests a new approach to lung cancer screening for American Indians and Alaska Natives. It is for adults aged 50-80 who have a history of smoking.

Why is this trial significant?

This trial addresses the critical gap in lung cancer screening for American Indians and Alaska Natives, who face higher mortality rates from the disease.

What are the potential risks of participating in NCT04948060?

The main risk is radiation exposure from the CT scan, though it is low-dose. There's a possibility of false positive results, leading to further tests and anxiety. Potential side effects of screening could include the need for biopsies or other procedures if abnormalities are found. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT04948060?

Ask your doctor if you are eligible and if this screening is right for you. Understand that participation may involve regular screening appointments and follow-up tests if needed. The study aims to make screening easier and more accessible within your community. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT04948060 signal from an investment perspective?

This trial focuses on a specific, underserved population, aiming to improve screening uptake and potentially reduce lung cancer deaths, which could signal a need for culturally tailored healthcare int This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves receiving enhanced lung cancer screening services and potentially smoking cessation support. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.