Enhanced Screening for Lung Cancer

(TEALS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Unwilling to be screened, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

480 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to enhance lung cancer screening for American Indian and Alaska Native communities, who experience higher lung cancer rates. The study will implement and test a new screening program using low-dose CT scans, part of the enhanced lung cancer screening services, to detect lung cancer early and potentially reduce mortality. Participants may also receive additional support, such as a care coordinator or technology assistance, to help navigate the screening process. This trial suits adults aged 50-80 with a significant smoking history (30 pack-years or more) who currently smoke or quit within the last 15 years. As an unphased trial, it offers participants the chance to contribute to important research that could improve health outcomes for their communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on lung cancer screening and smoking history.

What prior data suggests that this enhanced lung cancer screening service is safe?

Studies have shown that low-dose computed tomography (LDCT) safely and effectively screens for lung cancer. The United States Preventive Services Task Force recommends this test for adults aged 50 to 80 who have smoked. Research indicates that LDCT can detect lung cancer early and reduce the risk of death from it. The Centers for Medicare and Medicaid Services also support this screening, highlighting its safety and health benefits. Overall, patients tolerate LDCT well, and no major safety concerns have been reported with its use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about enhanced lung cancer screening services because they aim to improve early detection and treatment outcomes. Unlike standard screening practices that rely heavily on basic Electronic Health Record (EHR) reminders, this approach adds layers of support, such as learning collaboratives, information technology assistance, and care coordinators. These enhancements enable a more personalized and coordinated care experience, potentially increasing screening rates and early detection. By integrating quality of care benchmarking and practice facilitation, clinicians receive valuable feedback and support, which could lead to improved patient outcomes in lung cancer care.

What evidence suggests that this trial's enhanced lung cancer screening services could be effective for reducing lung cancer mortality in AI/AN communities?

Research has shown that low-dose computed tomography (LDCT) for lung cancer screening can lower the risk of death from lung cancer, particularly in heavy smokers. Studies have found that LDCT reduces lung cancer deaths by about 20% by detecting cancer early when treatment is more effective. However, LDCT screenings can sometimes produce false positives, suggesting cancer is present when it is not, leading to unnecessary follow-up tests. Despite this, the benefits of early detection and reduced mortality make LDCT a vital tool in combating lung cancer. This trial will evaluate enhanced lung cancer screening services, including LDCT, across various intervention arms to improve screening outcomes. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

The TEALS trial is for American Indian and Alaska Native adults aged 50-80 who have a history of heavy smoking (30 pack-years), including current smokers or those who quit within the last 15 years. It's not for individuals whose doctors decide they won't benefit from screening, or those unwilling to undergo follow-up tests or treatments if needed.

Inclusion Criteria

I am between 50 and 80 years old.

You have smoked a pack of cigarettes every day for 30 years.

You currently smoke or have quit smoking in the last 15 years.

Exclusion Criteria

Your primary care doctor has said that you would not benefit from the screening.

Those who are not willing to be screened or followed up with diagnostic testing or intervention, if positive

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Conduct focus groups and semi-structured interviews to identify barriers and facilitators for LCS implementation

12 months

Multiple visits for focus groups and interviews

Pilot Testing

Pilot test and iteratively improve the TEALS intervention in primary care practices

12 months

Cluster-randomized Trial

Conduct a cluster-randomized trial to measure the impact of the LCS program

24 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

12 months

Dissemination

Disseminate the TEALS program to other health systems serving AI/AN patients

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced lung cancer screening services

Trial Overview TEALS is testing enhanced lung cancer screening services in tribal healthcare systems. The study includes focus groups, development of care coordination interventions, and measures the impact through a cluster-randomized clinical trial to improve early detection and reduce mortality in AI/AN communities.

How Is the Trial Designed?

Group I: Intervention 1-5 Experimental Treatment 1 Intervention

In addition to control group improvements, patients and clinicians in the intervention group will also receive information technology support.

Group II: Intervention 1-4 Experimental Treatment 1 Intervention

In addition to control group improvements, patients and clinicians in the intervention group will also receive the opportunity to participate in a learning collaborative.

Group III: Intervention 1-3 Experimental Treatment 1 Intervention

In addition to control group improvements, patients and clinicians in the intervention group will also receive practice facilitation.

Group IV: Intervention 1-2 Experimental Treatment 1 Intervention

In addition to control group improvements, patients and clinicians in the intervention group will also receive quality of care benchmarking and feedback academic detailing.

Group V: Intervention 1-1 Experimental Treatment 1 Intervention

In addition to control group improvements, patients and clinicians in the intervention group will also receive an LCS Care Coordinator.

Group VI: Control 1-2 Experimental Treatment 1 Intervention

Patients and Clinicians in control practices will have access to existing LCS services, smoking cessation, and lung cancer treatment services, but no additional system improvements will be introduced.

Group VII: Control 1-1 Experimental Treatment 1 Intervention

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

Enhanced lung cancer screening services is already approved in United States for the following indications:

Approved in United States as Low-dose computed tomography (LDCT) lung cancer screening for:

• Lung cancer screening for men and women aged 55-80 years who meet specific eligibility criteria

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Choctaw Nation of Oklahoma

Collaborator

Trials

2

Recruited

1,100+

Published Research Related to This Trial

Targeting lung cancer screening using low-dose computed tomography (LDCT) to individuals at higher risk for lung cancer mortality can prevent more deaths, with benefits ranging from 1.2 to 9.5 deaths prevented per 10,000 person-years based on risk deciles.

However, the overall gains in life-years and quality-adjusted life-years (QALYs) are modest, with similar cost-effectiveness ratios across risk groups, suggesting that while risk-targeting improves early mortality outcomes, it does not significantly enhance overall efficiency in terms of life extension or cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk-Targeted Lung Cancer Screening: A Cost-Effectiveness Analysis. Kumar, V., Cohen, JT., van Klaveren, D., et al.[2022]

In the Korean Lung Cancer Screening Project (K-LUCAS), 5,692 high-risk participants were screened, revealing that 15.2% had positive results, with 0.7% confirmed cases of lung cancer, predominantly in early stages (66.7% stage I or II).

The study demonstrated that a national lung cancer screening program can effectively detect early-stage lung cancer and also promote smoking cessation among participants, with low associated anxiety and minimal complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of implementing a national lung cancer screening program: Interim results from the Korean Lung Cancer Screening Project (K-LUCAS). Lee, J., Kim, Y., Kim, HY., et al.[2022]

In a community-based lung cancer screening program involving 274 eligible patients, low-dose CT (LDCT) successfully detected malignancies in 4.0% of participants, including 8 cases of lung cancer.

The program identified 3 patients (1.1%) with early-stage lung cancer, who then received definitive therapy, demonstrating that LDCT screening can effectively detect early-stage lung cancer in a community health setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Outcomes of a Lung Cancer Screening Program in an Integrated Community Health System. Miller, AT., Kruger, P., Conner, K., et al.[2017]

From 2011 to 2018, the use of low-dose computed tomography (LDCT) for lung cancer screening in Veterans increased significantly, with initial screenings rising from 0 to 29.6 per 1000 eligible Veterans, indicating growing awareness and implementation of this early detection strategy.

Despite the increase, overall LDCT utilization remained low, highlighting the need for further interventions to encourage more Veterans to participate in lung cancer screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Lung Cancer Screening Utilization Trends in the Veterans Health Administration. Lewis, JA., Samuels, LR., Denton, J., et al.[2022]

In a study involving 8649 asymptomatic volunteers aged 50 to 75 with significant smoking histories, lung cancer screening using low-dose computed tomography (LDCT) detected lung cancer in 107 patients (1.24%), indicating the program's effectiveness in identifying cases early.

The majority of lung cancers were diagnosed at an early stage (Stage I non-small cell lung cancer in 79% of surgical patients), and the screening program had no perioperative deaths, highlighting its safety and potential for curative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of an open-access lung cancer screening program with low-dose computed tomography: the Gdańsk experience. Rzyman, W., Dziedzic, R., Jelitto-Górska, M., et al.[2019]

In a study of 272 patients screened for lung cancer using low dose computed tomography (LDCT), the lung cancer detection rate was 2.2%, which aligns with findings from the National Lung Screening Trial, indicating the efficacy of LDCT in identifying lung cancer.

The implementation of LDCT screening highlighted the importance of thorough pre-screening evaluations and careful scanning protocols to ensure patient safety, with a mean radiation dose of 3.12 mGy achieved through techniques like tube current modulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose Lung Cancer Screening at an Academic Medical Center: Initial Experience and Dose Reduction Strategies. Ahmed, A., Verma, N., Barreto, I., et al.[2019]

Oncology nurse navigation significantly improved provider education about low-dose computed tomography (LDCT) lung cancer screening, leading to better discussions about tobacco cessation and increased adherence to screening protocols.

During a five-month intervention involving 133 eligible patients, the time taken for providers and patients to be notified about LDCT results was significantly reduced, indicating enhanced efficiency in the screening process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Dose Computed Tomography: Effects of Oncology Nurse Navigation on Lung Cancer Screening. Watson, J., Broome, ME., Schneider, SM.[2021]

73% of adult oncology practice groups in the NCORP network offered low-dose CT lung screening on site, indicating widespread access to this potentially life-saving screening method for high-risk individuals.

While the majority of practices provided lung screening, only 47% were designated as ACR Lung Cancer Screening Centers, and radiologist involvement in service management was present in 69% of the services, highlighting variability in service quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening in the National Cancer Institute Community Oncology Research Program: Availability and Service Organization. Carlos, RC., Sicks, JD., Chiles, C., et al.[2023]

Annual low-radiation-dose computed tomography (LDCT) screening can significantly reduce lung cancer mortality in high-risk individuals, but its implementation requires careful planning to maximize benefits and minimize harms.

The American Thoracic Society and American College of Chest Physicians provide a framework for developing LDCT screening programs, outlining essential strategies for planning, implementation, and maintenance to ensure these programs are safe, effective, and sustainable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An official American Thoracic Society/American College of Chest Physicians policy statement: implementation of low-dose computed tomography lung cancer screening programs in clinical practice. Wiener, RS., Gould, MK., Arenberg, DA., et al.[2022]

Lung cancer screening using low-dose helical computed tomography (LDCT) significantly improves the chances of early diagnosis and increases survival rates for high-risk individuals.

Identifying risk factors and qualifying patients for LDCT screening is crucial, and healthcare professionals, especially nurses, play a vital role in supporting and educating patients about the screening process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Case for Lung Cancer Screening: What Nurses Need to Know. Sorrie, K., Cates, L., Hill, A.[2017]

In a study of 454 participants undergoing lung cancer screening with low-dose computed tomography (LDCT), individuals with a history of cancer were significantly less likely to have abnormal screening results (9.8%) compared to those without a cancer history (15.4%), although this difference was not statistically significant (P = .11).

Despite having a higher predicted risk of lung cancer (4.8% vs. 2.2% for those without cancer history), individuals with a previous malignancy were less likely to be diagnosed with lung cancer (1.3% vs. 3.5%), suggesting that prior cancer history may influence screening outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Outcomes of Lung Cancer Screening Among Individuals With or Without Cancer History. Maller, B., Simmons, VN., Byrne, MM., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9311401/

Low‐dose computed tomography lung cancer screening This review provides an overview of current evidence for LDCT lung cancer screening, and draws attention to major factors that need to be addressed.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0959804925003521

Review Current evidence of low-dose CT screening benefit LDCT screening has emerged as a powerful tool for early detection, enabling diagnosis at curable stages and reducing lung cancer mortality.

3. cms.gov cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274&bc=AAAAAAAAAgAAAA

Screening for Lung Cancer with Low Dose Computed ... Outcomes of lung cancer screening with low-dose computed tomography ... These data will not only verify that screening leads to improved health outcomes ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2777242

Screening for Lung Cancer With Low-Dose Computed ... Screening high-risk persons with LDCT can reduce lung cancer mortality but also causes false-positive results leading to unnecessary tests and invasive ...

5. cancer.gov cancer.gov/types/lung/hp/lung-screening-pdq

Lung Cancer Screening (PDQ®) - NCI Lung cancer screening with low-dose spiral CT scans has been shown to decrease the risk of dying from lung cancer in heavy smokers.

6. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening

Recommendation: Lung Cancer: Screening The USPSTF recommends annual screening for lung cancer with LDCT in adults aged 50 to 80 years who have at least a 20 pack-year smoking history.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4380288/

Lung Cancer Screening with Low-Dose Computed ... This review provides an update on lung cancer screening with low-dose computed tomography (LDCT) and its implications for primary care providers.

8. cdc.gov cdc.gov/lung-cancer/screening/index.html

Screening for Lung Cancer The only recommended screening test for lung cancer is low-dose computed tomography (also called a low-dose CT scan, or LDCT).