Engaged Approach for Lung Cancer Screening

Overseen By Kaitlyn Hoover

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to assess feasibility and acceptability of the Engaged Approach to Lung Cancer Screening (EA-LCS) in diverse lung cancer screening (LCS) programs operating in a variety of geographic regions across Colorado and the US.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Engaged Approach to Lung Cancer Screening (EA-LCS)?

The National Lung Screening Trial showed that lung cancer screening with low-dose CT scans can reduce lung cancer deaths by 20% in older heavy smokers. This suggests that structured screening programs, like EA-LCS, could be effective if they incorporate personalized approaches and patient engagement, as highlighted in the ENGAGE framework. ^{1 2 3 4 5}

How does the Engaged Approach for Lung Cancer Screening differ from other treatments for lung cancer?

The Engaged Approach for Lung Cancer Screening is unique because it focuses on improving communication and shared decision-making between patients and clinicians, rather than introducing a new drug or medical procedure. This approach aims to enhance patient participation and adherence to screening recommendations, which is crucial for the success of lung cancer screening programs. ^{1 6 7 8 9}

Research Team

Jamie Studts, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for individuals who are eligible for lung cancer screening. Specific eligibility details, such as age range or risk factors like smoking history, aren't provided here. The study aims to include a diverse group from various regions in Colorado and the US.

Inclusion Criteria

My program performs over 50 low-dose CT scans yearly.

LCS Program: Must be able to identify a primary contact person for LCS program operations (e.g., program coordinator, program navigator, program manager, etc.)

Staff member: Identified staff member of the LCS program site

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Sites randomized to use the EA-LCS materials will access the program/toolkit web portal and use materials fitting clinic procedures

12 months

Control

Sites in the control condition will complete surveys and interviews and use the Electronic Health Record Data Abstraction process

12 months

Follow-up

Participants are monitored for feasibility, appropriateness, and acceptability of the intervention

12 months

Treatment Details

Interventions

• Engaged Approach to Lung Cancer Screening

Trial Overview The study is testing the 'Engaged Approach to Lung Cancer Screening' (EA-LCS), which likely involves strategies to improve patient participation and effectiveness of lung cancer screenings across different locations.

Participant Groups

Group I: Experimental Group Experimental Treatment 1 Intervention

Sites randomized to use the EA-LCS materials will be given password-protected access to the program/toolkit web portal and encouraged to use any materials that fit the normal flow of clinic procedures. Materials available include both staff-facing and LCS candidate-facing materials.

Group II: Control Group Active Control 1 Intervention

Sites in the control condition will be asked to complete appropriate/relevant surveys and interviews with minor modifications as needed and use the same Electronic Health Record Data Abstraction process.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

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]

Personalized lung cancer screening aims to tailor screening decisions based on individual characteristics and preferences, enhancing the relevance and effectiveness of the approach.

The ENGAGE framework is a valuable tool that facilitates discussions about balancing effectiveness, efficiency, and equity in lung cancer screening, ensuring that patient input is considered in decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized lung cancer screening: Are we ready to ENGAGE? Gould, MK.[2022]

The National Lung Screening Trial found that annual low-dose CT scans can reduce lung cancer-specific mortality by 20% in older heavy smokers, highlighting the potential effectiveness of lung cancer screening.

To maximize the benefits of lung cancer screening, ongoing research is essential for improving risk assessment, patient communication, and management of detected abnormalities, ensuring that screening programs are implemented responsibly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung cancer screening. Arenberg, D.[2015]

In a study of 1388 Veterans, personal risk of lung cancer was identified as the most important factor influencing decisions about lung cancer screening, while health risks from screening were considered the least important.

Veterans who received a Direct LCS Invitation with a decision aid were more likely to consider specific factors like false-positive results and screening convenience important, highlighting the effectiveness of decision tools in shaping patient perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What factors do patients consider most important in making lung cancer screening decisions? Findings from a demonstration project conducted in the Veterans Health Administration. Lillie, SE., Fu, SS., Fabbrini, AE., et al.[2018]

A systematic review of 32 studies on lung cancer screening (LCS) found that targeted interventions, like smoking cessation programs, can positively influence psychosocial outcomes, such as increasing motivation to quit smoking.

However, the overall impact of service delivery components on psychological outcomes was inconsistent, highlighting the need for more high-quality, real-world studies to better understand how to optimize LCS programs for improved psychosocial well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung cancer screening program factors that influence psychosocial outcomes: A systematic review. McFadden, K., Rankin, NM., Nickel, B., et al.[2023]

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]

The LungCARE tool significantly improved discussions about lung cancer screening (LCS) between patients and physicians, with 56% of LungCARE participants discussing LCS compared to only 25% in usual care.

Participants using LungCARE were more likely to be referred for and complete LCS (44% referred and 32% completed) compared to those receiving usual care (13% referred and 13% completed), and they also demonstrated better knowledge about LCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LungCARE: Encouraging Shared Decision-Making in Lung Cancer Screening-a Randomized Trial. Walsh, JME., Karliner, L., Smith, A., et al.[2023]

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]

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]

References

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

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

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

Personalized lung cancer screening: Are we ready to ENGAGE? [2022]

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

Lung cancer screening. [2015]

4. Ireland pubmed.ncbi.nlm.nih.gov

What factors do patients consider most important in making lung cancer screening decisions? Findings from a demonstration project conducted in the Veterans Health Administration. [2018]

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

Lung cancer screening program factors that influence psychosocial outcomes: A systematic review. [2023]

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

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

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

LungCARE: Encouraging Shared Decision-Making in Lung Cancer Screening-a Randomized Trial. [2023]

8. 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]

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

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