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

Trial Summary

What is the purpose of this trial?

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 implementation tend to be understudied compared to those evaluating individual-level, behavioral interventions. However, the careful development and evaluation of an LCS screening program at the level of the healthcare system would be critical to ensure that more patients can receive LCS. Our research will create a critically needed platform from which future studies could be launched that will examine how to tailor the application of the LCS guideline to the individual preferences of AI/AN patients. TEALS will establish an effective LCS program in a tribal system and thus provide a direct benefit to the Choctaw Nation by increasing LCS participation. TEALS will serve as a blueprint for establishing a sustainable and accessible infrastructure for LCS in AI/AN and other community health systems. By increasing screening for early stage lung cancer, TEALS could ultimately reduce lung cancer mortality in AI/AN 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 data supports the effectiveness of the treatment Enhanced lung cancer screening services, Low-dose computed tomography (LDCT) lung cancer screening, Enhanced lung cancer screening services?

Research shows that low-dose computed tomography (LDCT) is an effective method for early detection of lung cancer, which can reduce mortality rates in high-risk groups. Studies have demonstrated its success in decreasing lung cancer deaths, making it a promising tool for screening. ^{1 2 3 4 5}

Is low-dose computed tomography (LDCT) lung cancer screening safe for humans?

Low-dose computed tomography (LDCT) lung cancer screening is generally considered safe for humans, as it uses a lower amount of radiation compared to standard CT scans, which helps reduce potential risks. However, careful planning is needed to ensure the benefits of screening outweigh any possible harms. ^{1 6 7 8 9}

How is the Enhanced lung cancer screening treatment different from other treatments for lung cancer?

Enhanced lung cancer screening using low-dose computed tomography (LDCT) is unique because it focuses on early detection of lung cancer in high-risk individuals, which can lead to earlier diagnosis and improved survival rates. Unlike treatments that address existing cancer, this screening method aims to catch cancer early before symptoms appear, potentially reducing mortality. ^{1 4 7 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Low-dose Lung Cancer Screening at an Academic Medical Center: Initial Experience and Dose Reduction Strategies. [2019]

2. England pubmed.ncbi.nlm.nih.gov

National Lung Cancer Screening Utilization Trends in the Veterans Health Administration. [2022]

3. Poland pubmed.ncbi.nlm.nih.gov

Results of an open-access lung cancer screening program with low-dose computed tomography: the Gdańsk experience. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Low-Dose Computed Tomography: Effects of Oncology Nurse Navigation on Lung Cancer Screening. [2021]

5. China 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). [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening in the National Cancer Institute Community Oncology Research Program: Availability and Service Organization. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Initial Outcomes of a Lung Cancer Screening Program in an Integrated Community Health System. [2017]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Characteristics and Outcomes of Lung Cancer Screening Among Individuals With or Without Cancer History. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The Case for Lung Cancer Screening: What Nurses Need to Know. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Risk-Targeted Lung Cancer Screening: A Cost-Effectiveness Analysis. [2022]