Screening Program for Lung Cancer

(LUCARE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Psychiatric illness, Intoxicated, Life-threatening condition, 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

144 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment ED-LCS for lung cancer screening?

Research shows that lung cancer screening with low-dose computed tomography (LDCT) can reduce mortality from lung cancer. The use of shared decision-making (SDM) and counseling is recommended to help patients understand the benefits and risks of screening, which is a part of the ED-LCS intervention. ^{1 2 3 4 5}

Is the lung cancer screening program safe for humans?

The lung cancer screening program using low-dose CT scans is generally considered safe, with rare harms reported, especially in diverse populations. ^{2 6 7 8 9}

How is the ED-LCS treatment for lung cancer different from other treatments?

The ED-LCS treatment is unique because it focuses on screening for lung cancer in emergency department settings, which is not a common practice for lung cancer detection. This approach aims to identify high-risk patients who might not otherwise participate in traditional screening programs, potentially leading to earlier diagnosis and treatment. ^{9 10 11 12 13}

What is the purpose of this trial?

The overall objective of this mixed methods study is to: 1) Refine the Emergency Department Lung Cancer Screening (ED-LCS) intervention using qualitative interviews among key stakeholders; 2) pilot test the ED-LCS intervention evaluating the intervention efficacy, acceptability, and feasibility; and 3) provide an in-depth description of stakeholders' experiences with the ED-LCS intervention for future refinement.

Eligibility Criteria

This trial is for individuals who may be at risk of lung cancer. The study aims to refine and test a new screening method called ED-LCS, which will be evaluated in the emergency department setting. Specific eligibility criteria are not provided.

Inclusion Criteria

I am between 50-80 years old and have a significant smoking history.

Exclusion Criteria

Have received chest CT scan in past 12 months

Already enrolled in LCS

Decompensated psychiatric illness (suicidal, homicidal, psychosis) - Will confirm with attending physicians at time of enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Refinement

Refinement of the Emergency Department Lung Cancer Screening (ED-LCS) intervention using qualitative interviews among key stakeholders

4-6 weeks

Pilot Testing

Pilot test the ED-LCS intervention evaluating the intervention efficacy, acceptability, and feasibility

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

Treatment Details

Interventions

• ED-LCS

Trial Overview The study is testing the Emergency Department Lung Cancer Screening (ED-LCS) intervention. It involves refining the screening process through interviews with stakeholders, pilot testing its effectiveness, acceptability, and feasibility, followed by an analysis of stakeholder experiences.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Patients will be shown a modified version of LungTalk.

Group II: Usual Care Active Control 1 Intervention

Patients will receive usual care.

ED-LCS is already approved in United States for the following indications:

Approved in United States as ED-LCS for:

• Lung cancer screening for high-risk individuals

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Eskenazi Health

Collaborator

Trials

14

Recruited

3,700+

Findings from Research

A centralized lung cancer screening program at the Iowa City Veterans Affairs Medical Center effectively utilized shared decision-making (SDM) and telehealth to support veterans, with 91 out of 105 veterans opting for low-dose computed tomography (LDCT) after counseling.

Despite high confidence in their screening decisions, many veterans lacked critical knowledge about the risks and benefits of screening, indicating a need for improved patient education and decision support during the referral process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a Telehealth Shared Counseling and Decision-Making Visit for Lung Cancer Screening in a Veterans Affairs Medical Center. Hoffman, RM., Lang, JA., Bailey, GJ., et al.[2023]

In a study of 995 patients undergoing lung cancer screening with low-dose computed tomography (LDCT), 2.9% were diagnosed with lung cancer, indicating that screening can lead to early detection in a predominantly African American population.

The screening had a false-positive rate of 9.4%, with very few complications (0.7% from false-positive procedures), highlighting that while harms are rare, they need to be communicated effectively to patients, especially in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening in a Safety-Net Hospital: Rare Harms Inform Decision Making. Lutzow, LK., Magarinos, J., Dass, C., et al.[2022]

In a study of 28,294 veterans screened for lung cancer from 2015 to 2019, only 63.1% received timely follow-up care as recommended, highlighting a significant gap in adherence to lung cancer screening protocols.

Factors such as being Black, having mental health disorders, lower income, and living farther from healthcare facilities were associated with a higher likelihood of delayed or absent follow-up, indicating disparities in access to care that need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Follow-up Testing Recommendations in US Veterans Screened for Lung Cancer, 2015-2019. Núñez, ER., Caverly, TJ., Zhang, S., et al.[2022]

In a survey of 1463 current and former smokers in France, 36.4% of current smokers and 26.3% of former smokers expressed willingness to participate in lung cancer screening (LCS), indicating a significant gap between target populations and actual participation.

Factors influencing participation intentions varied: current smokers were more likely to participate if they had been screened before, had fewer than 30 pack-years of smoking, intended to quit, and had no social vulnerabilities, while former smokers with comorbidities were less likely to participate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and Former Smokers: Who Wants To Be Screened? Couraud, S., Greillier, L., Brignoli-Guibaudet, L., et al.[2019]

In a study of 660 smokers eligible for lung cancer screening, 19.4% reported poor exercise capacity (EC), which was significantly associated with comorbidities like COPD, heart failure, and cardiovascular disease.

Patients with COPD and heart failure had a particularly high prevalence of poor EC, with 57% reporting poor capacity, highlighting the need for careful consideration of exercise capacity and comorbidities in lung cancer screening eligibility and decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported exercise capacity among current smokers eligible for lung cancer screening: Distribution and association with key comorbidities. Melzer, AC., Begnaud, A., Lindgren, BR., et al.[2022]

In a study of 4,176 patients undergoing lung cancer screening with low-dose CT, the cancer detection rate was 3.8%, significantly higher than the 2.4% reported in the National Lung Screening Trial, indicating improved effectiveness in real-world settings.

Most cancers detected were early-stage (71% stage I), and the study reported low complication rates (24%) and a lower mortality rate (0.45%) over a median follow-up of 3.3 years, suggesting that lung cancer screening is both safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Outcomes of Lung Cancers Detected on Low-Dose Lung Cancer Screening CT. Zhang, EW., Shepard, JO., Kuo, A., et al.[2022]

In a study involving 51 patients undergoing lung cancer screening, participants expressed high satisfaction with the information provided by clinicians, despite recalling few specific harms or benefits of the screening.

Patients reported a strong sense of trust in their clinicians and were generally satisfied with their role in the decision-making process, even though the communication did not fully align with the ideal of shared decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I'm Putting My Trust in Their Hands": A Qualitative Study of Patients' Views on Clinician Initial Communication About Lung Cancer Screening. Golden, SE., Ono, SS., Thakurta, SG., et al.[2021]

In a study of 843 high-risk individuals for lung cancer, screening with low-dose computed tomography (LCS) led to increased readiness to quit smoking in 25.7% of participants and improved motivation to quit, although only 1.3% reported actually quitting.

Participants who experienced extreme worry about lung cancer were more likely to be ready to quit smoking and showed higher motivation, suggesting that LCS can serve as a teachable moment for smoking cessation, especially for first-time scan recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved motivation and readiness to quit shortly after lung cancer screening: Evidence for a teachable moment. Williams, RM., Cordon, M., Eyestone, E., et al.[2023]

After implementing process modifications, compliance with lung cancer screening (LCS) guidelines at Kaiser Permanente Colorado improved significantly, with eligible patients increasing from 45.6% to 92.7%.

Patients screened at KPCO had a higher lung cancer detection rate (9.4%) compared to the National Lung Screening Trial (3.8%), indicating that real-world settings may yield different outcomes and warrant further study on long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world Clinical Implementation of Lung Cancer Screening-Evaluating Processes to Improve Screening Guidelines-Concordance. Carroll, NM., Burnett-Hartman, AN., Joyce, CA., et al.[2021]

In a study of 624 patients in a lung cancer screening program, there were no significant differences in characteristics or outcomes between patients screened by primary care providers (PCPs) and specialists, indicating that both approaches are equally effective.

Implementing systematic interventions like a best practice advisory (BPA) and a nurse navigator significantly improved screening quality, leading to over 95% documentation of shared decision-making and tobacco cessation counseling, while also reducing the screening of ineligible patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Hybrid Lung Cancer Screening Model on Patient Outcomes and Provider Behavior. Hirsch, EA., New, ML., Brown, SL., et al.[2021]

A study involving 51 patients and 24 clinicians found that discussions about lung cancer screening (LCS) are not perceived as effective teachable moments for encouraging smoking cessation, despite clinicians believing they could influence smoking behaviors.

The research suggests that the emotional impact during LCS discussions may not be strong enough to motivate significant behavior changes like quitting smoking, indicating a need for improved communication strategies to enhance motivation for cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I Already Know That Smoking Ain't Good for Me": Patient and Clinician Perspectives on Lung Cancer Screening Decision-Making Discussions as a Teachable Moment. Golden, SE., Ono, SS., Melzer, A., et al.[2022]

The implementation of lung screening programs is crucial for early detection and treatment of lung cancer, with successful examples from the Mount Sinai Healthcare System and the Phoenix Veterans Affairs Health Care System, utilizing the Early Lung Cancer Action Program (ELCAP) Management System.

Annual lung screening is essential, especially for heavy smokers, as it significantly increases the chances of curing lung cancer, highlighting the need for continuous evaluation and adaptation of screening programs to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of low-dose CT screening in two different health care systems: Mount Sinai Healthcare System and Phoenix VA Health Care System. Henschke, CI., Yankelevitz, DF., Jirapatnakul, A., et al.[2021]

The quality improvement project led to a significant and sustained increase in lung cancer screening (LCS) referrals from primary care providers, with 337 initial referrals predominantly consisting of men, particularly from minority groups.

Despite the increase in referrals, 25% of veterans did not attend their scheduled screenings, highlighting the need to address transportation barriers and other socioeconomic factors that may affect access to screening, especially in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting lung cancer screening of high-risk patients by primary care providers. Colamonici, M., Khouzam, N., Dell, C., et al.[2023]

References

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

Implementing a Telehealth Shared Counseling and Decision-Making Visit for Lung Cancer Screening in a Veterans Affairs Medical Center. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening in a Safety-Net Hospital: Rare Harms Inform Decision Making. [2022]

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

Adherence to Follow-up Testing Recommendations in US Veterans Screened for Lung Cancer, 2015-2019. [2022]

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

Current and Former Smokers: Who Wants To Be Screened? [2019]

5. England pubmed.ncbi.nlm.nih.gov

Self-reported exercise capacity among current smokers eligible for lung cancer screening: Distribution and association with key comorbidities. [2022]

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

Characteristics and Outcomes of Lung Cancers Detected on Low-Dose Lung Cancer Screening CT. [2022]

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

"I'm Putting My Trust in Their Hands": A Qualitative Study of Patients' Views on Clinician Initial Communication About Lung Cancer Screening. [2021]

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

Improved motivation and readiness to quit shortly after lung cancer screening: Evidence for a teachable moment. [2023]

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

Real-world Clinical Implementation of Lung Cancer Screening-Evaluating Processes to Improve Screening Guidelines-Concordance. [2021]

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

Impact of a Hybrid Lung Cancer Screening Model on Patient Outcomes and Provider Behavior. [2021]

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

"I Already Know That Smoking Ain't Good for Me": Patient and Clinician Perspectives on Lung Cancer Screening Decision-Making Discussions as a Teachable Moment. [2022]

12. China pubmed.ncbi.nlm.nih.gov

Implementation of low-dose CT screening in two different health care systems: Mount Sinai Healthcare System and Phoenix VA Health Care System. [2021]

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

Promoting lung cancer screening of high-risk patients by primary care providers. [2023]