Centralized Screening Unit for Lung Cancer

Recruiting at 1 trial location

Overseen By Yocheved Halberstam, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Disqualifiers: Chest CT, Lung cancer, others

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

Compensation: Varies

Number of Visits: Unknown

9460 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost lung cancer screening in the Bronx by using a Centralized Screening Unit (CSU) to streamline the process for doctors and patients. The CSU will collect smoking histories, determine screening eligibility, and arrange follow-ups, which should increase the number of low-dose CT scans. The trial seeks to reduce late-stage lung cancer diagnoses in the area. Suitable candidates for this trial include current or former smokers who smoked a pack a day for 20 years and have not had a chest CT in the past year. As an unphased trial, this study offers the opportunity to contribute to innovative screening methods that could benefit the community.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on lung cancer screening, so it's unlikely that you'll need to change your medications, but you should confirm with the trial coordinators.

Do I need to stop my current medications for this trial?

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

What prior data suggests that the Centralized Screening Unit is safe for increasing lung cancer screening?

Research shows that using a Centralized Screening Unit (CSU) for lung cancer doesn't involve direct medical treatment, eliminating risks like drug side effects. Instead, it organizes lung cancer screenings. Studies have found that these centralized systems can increase screening rates, allowing more people to catch lung cancer early and potentially save lives.

The CSU sends reminders and offers support to patients, increasing their chances of attending screenings. This focus on coordination and support aims to make the process smoother and more accessible for patients. No evidence suggests any harm from participating in a CSU program, as it primarily involves communication and organizing screenings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Centralized Screening Unit (CSU) for lung cancer screening because it revolutionizes how eligible patients are identified and engaged. Unlike current methods that rely heavily on in-person appointments and manual patient follow-ups, the CSU uses electronic medical records to automatically send messages to patients who qualify for lung cancer screening. This proactive approach not only increases patient awareness but also offers personalized support through lay navigators, ensuring that more patients receive timely screenings. By streamlining the screening process and enhancing patient outreach, the CSU has the potential to significantly boost early detection rates and improve outcomes for lung cancer patients.

What evidence suggests that the Centralized Screening Unit is effective for increasing lung cancer screening?

Research has shown that centralized lung cancer screening programs can improve patient outcomes. Studies have found that low-dose CT scans for screening can reduce lung cancer deaths by about 20%. This trial tests the Centralized Screening Unit (CSU) as an intervention. Centralized programs, such as the CSU, often achieve better patient participation than decentralized ones. This likely results from the increased support and organization these programs provide. By managing routine tasks, centralized units simplify the screening process and help patients maintain their care. ^{1 3 4 6 7}

Who Is on the Research Team?

H. Dean Hosgood, PhD

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals in the Bronx, New York who may be at risk of lung cancer and could benefit from increased screening. The study aims to improve low-dose computed tomography (LDCT) scan rates by implementing a Centralized Screening Unit (CSU). Specific eligibility criteria are not provided but likely include those at high risk for lung cancer.

Inclusion Criteria

Clinic level: a NYC RING affiliated clinic, Opt into and agree to research protocol

I am 50-77 years old, a current or former smoker with a 20+ pack-year history, quit within the last 15 years, no recent chest CT, and no lung cancer history.

Exclusion Criteria

Patient level: Primary care provider instruction to not contact an individual for any reason. Any individual inadvertently contacted who does not meet these criteria will be excluded from the study.

Clinic level: only treats pediatric patients, Opt out of research protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Centralized Screening Unit (CSU) Intervention

Implementation of a Centralized Screening Unit to increase lung cancer screening uptake by leveraging EMR data and providing patient navigation and support services.

Approximately 2.5 years

Follow-up

Participants are monitored for adherence to lung cancer screening and follow-up care, including tracking and support for annual re-screening.

Approximately 2.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Centralized Screening Unit Implementation

Trial Overview The intervention being tested is the implementation of a CSU designed to streamline lung-cancer screening processes like collecting smoking history, determining eligibility, and arranging follow-ups. The goal is to see if this approach increases adherence to LCS guidelines and LDCT screenings among patients.

How Is the Trial Designed?

Group I: Centralized Screening Unit (CSU) Experimental Treatment 1 Intervention

The CSU intervention will shift workflow by leveraging EMR data to direct automated messages to LCS-eligible patients, inviting them to connect with the CSU. The CSU incorporates evidence-based strategies for active outreach to inform patients about LCS and to offer support from lay navigators. Patients are identified through "meaningful use" of medical records data

Group II: No Intervention Yet Started Active Control 1 Intervention

Standard of Care during the "no intervention" period

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

The lung cancer screening program at St Elizabeth Healthcare has successfully diagnosed 342 lung cancers through screening, representing 13.2% of total diagnoses, and has shown a clear shift towards earlier stage detection in screened patients compared to non-screened patients.

Despite nearly 50% of eligible patients being screened in 2021, the study identified a significant number of individuals who could have been screened, indicating the need to address barriers to screening and enhance early detection efforts in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming barriers to lung cancer screening using a systemwide approach with additional focus on the non-screened. Gieske, MR., Kerns, J., Schmitt, GM., et al.[2023]

Low-dose computed tomography (LDCT) screening has been shown to benefit high-risk individuals by increasing the detection of early-stage lung cancer, which can lead to potentially curable outcomes.

Despite the advantages of LDCT screening, it is important to understand the potential harms associated with screening to optimize its benefits and minimize risks in lung cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung cancer screening. Gutierrez, A., Suh, R., Abtin, F., et al.[2021]

Lung cancer screening has been shown to improve survival rates, but many people are not participating in these screenings due to various barriers.

The authors emphasize the importance of creating a tailored and adaptable lung cancer screening program that addresses community needs, involves key stakeholders, and optimizes health systems for better patient follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building a Lung Cancer Screening Program. Chudgar, NP., Stiles, BM.[2023]

A study of 739 lung cancer cases from 1980 to 1995 demonstrated the effectiveness of a specialized screening program for early diagnosis, which contributed to improved patient outcomes.

The centralized system for collecting and processing cancer data allowed for better tracking and management of cases, leading to observed improvements in 5- and 10-year survival rates for lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The current status of the diagnosis of lung cancer under the conditions of the long-term dispensary care of a population group]. Denisov, LE., Nikolaev, AP., Vinogradova, NN., et al.[2006]

Lung cancer screening using low-dose chest CT scans can significantly reduce lung cancer mortality in a very high-risk group, highlighting its efficacy as a preventive measure.

Successful implementation of lung cancer screening programs requires addressing 11 identified obstacles, emphasizing the need for a multi-disciplinary approach and viewing screening as a comprehensive program rather than just a single test.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstacles to and Solutions for a Successful Lung Cancer Screening Program. Mazzone, PJ.[2018]

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]

A survey of 122 Veterans Health Administration facilities revealed that centralized lung cancer screening programs are more likely to implement key supportive practices, such as screening registries and dedicated coordinators, compared to hybrid and decentralized programs.

Out of the 69 facilities that completed the survey, 37.7% identified as having centralized programs, indicating that the structure of the screening program can significantly impact the quality and effectiveness of lung cancer screening efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Survey of Lung Cancer Screening Practices in Veterans Health Administration Facilities. Núñez, ER., Slatore, CG., Tanner, NT., et al.[2023]

The Swiss Lung Cancer Screening Implementation Group (CH-LSIG) is working on establishing a national lung cancer screening program using low-dose chest CT scans, focusing on feasibility and key unanswered questions.

Future discussions with patients will emphasize a shared decision-making approach, and pilot projects will help determine the best strategies for implementing the screening program based on scientific evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lung cancer screening in Switzerland : Who ? How ? When ?] Casutt, A., Lovis, A., Selby, K., et al.[2020]

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 comprehensive management platform for pulmonary nodules was implemented in West China Hospital, screening 2,836 individuals over 40 years old, which led to the diagnosis of 66 lung cancer cases, primarily at early stages.

The study highlights that effective screening and follow-up can significantly improve early detection and treatment of lung cancer, suggesting a model that could be expanded across western China to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pulmonary Nodules/Lung Cancer Comprehensive Management Mode: Design and Application]. Liu, D., Huang, Y., Zhou, Q., et al.[2021]

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Lung cancer screening: learning from implementation Smoking cessation results in better clinical outcomes for people who participate in screening and improves lung cancer survival rates. LDCT can also offer the ...