Centralized Screening Unit for Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen by H. Dean Hosgood, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Albert Einstein College of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study proposes to increase Lung-cancer screening (LCS) in the Bronx, New York. Despite strong evidence that Lung-cancer screening (LCS) can reduce Lung cancer (LCa) deaths, low-dose computed tomography (LDCT) referral rates by clinicians are very low and there is poor adherence with LCS by patients. Both provider and patient barriers may be amenable to systemic improvements in support, coordination and infrastructure for screening. The investigator team hypothesizes that the implementation of a Central Screening Unit (CSU) that shifts routine workflow attributed to LCS (e.g., collection of smoking history, determination of eligibility, shared decision making and arranging follow-up) away from busy practices (usual care) and that offers patients an array of navigation and support services will increase the uptake of LCS guidelines and subsequent low-dose computed tomography (LDCT) screening scans in a low-income, predominately Hispanic and Black catchment area. The proposed study represents a unique opportunity to test this hypothesis in the context of the roll out of a CSU as a significant new component of the Montefiore-Einstein health system. The investigator team will examine whether and how the CSU facilitates LCS uptake and retention of patients. This study is powered to test whether CSU reduces proportion of late-stage lung cancer diagnoses in the Bronx, New York.

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.

What data supports the idea that Centralized Screening Unit for Lung Cancer is an effective treatment?

The available research shows that centralized screening for lung cancer can improve survival rates by detecting cancer early. For example, one study observed improved 5- and 10-year survival rates due to early diagnosis through a centralized system. Another study highlighted that most patients diagnosed with lung cancer through annual screenings can be cured, emphasizing the importance of early detection. These findings suggest that centralized screening is effective in improving outcomes for lung cancer patients. ^{1 2 3 4 5}

What safety data exists for the Centralized Screening Unit for Lung Cancer?

The research does not provide specific safety data for the Centralized Screening Unit for Lung Cancer. However, it discusses the benefits and potential harms of lung cancer screening programs in general, such as anxiety and morbidity related to screen-detected findings. It emphasizes the importance of careful implementation to balance benefits and harms, suggesting that a well-structured program can mitigate risks. ^{1 2 6 7 8}

Is the treatment in the Centralized Screening Unit for Lung Cancer a promising treatment?

Yes, the centralized screening unit for lung cancer is promising because it helps detect lung cancer early, which can save lives. It improves survival rates by organizing and optimizing the screening process, making it easier for people to get screened and follow up on their results. ^{1 2 3 9 10}

Eligibility Criteria

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

Treatment Details

Interventions

• Centralized Screening Unit Implementation (Behavioural Intervention)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Montefiore Medical Center's New York City Research and Improvement Networking Group (NYC RING) Bronx, NY

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine Lead Sponsor

American Cancer Society, Inc. Collaborator

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

National Survey of Lung Cancer Screening Practices in Veterans Health Administration Facilities. [2023] Lung cancer screening can save lives through the early detection of lung cancer, and professional societies recommend key lung cancer screening program components to ensure high-quality screening. Yet, little is known about the key components that comprise the various screening program models in routine clinical settings. The objective was to compare the utilization of these key components across centralized, hybrid, and decentralized lung cancer screening programs.

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

Building a Lung Cancer Screening Program. [2023] Lung cancer screening improves lung-cancer specific and potentially overall survival; however, uptake rates are concerningly low. Several barriers to screening exist and require a systemic approach to address. The authors describe their approach toward building a centralized lung cancer screening program at an urban academic center along with lessons learned. To this end, the identification of involved stakeholders, evaluation of community barriers and needs, optimization of the electronic health system, and implementation of system of standardized follow-up for patients are processes for consideration. Perhaps most important to undertaking this endeavor is the need to customize each program and maintain adaptability.

3. Russia (Federation) 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]. [2006] In 1980-1995 the authors observed 739 cases of lung cancer. A special screening program on early diagnosis of lung cancer has been developed. The centralized system of the information collection, storage and processing of all the cancer cases, follow-up of all the registered cases provided observed and corrected 5- and 10-year survival. Efficacy of screening and early treatment is shown.

4. 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] Implementation of lung screening (LS) programs is challenging even among health care organizations that have the motivation, the resources, and more importantly, the goal of providing for life-saving early detection, diagnosis, and treatment of lung cancer. We provide a case study of LS implementation in different healthcare systems, at the Mount Sinai Healthcare System (MSHS) in New York City, and at the Phoenix Veterans Affairs Health Care System (PVAHCS) in Phoenix, Arizona. This will illustrate the commonalities and differences of the LS implementation process in two very different health care systems in very different parts of the United States. Underlying the successful implementation of these LS programs was the use of a comprehensive management system, the Early Lung Cancer Action Program (ELCAP) Management SystemTM. The collaboration between MSHS and PVAHCS over the past decade led to the ELCAP Management SystemTM being gifted by the Early Diagnosis and Treatment Research Foundation to the PVAHCS, to develop a "VA-ELCAP" version. While there remain challenges and opportunities to continue improving LS and its implementation, there is an increasing realization that most patients who are diagnosed with lung cancer as a result of annual LS can be cured, and that of all the possible risks associated with LS, the greater risk of all is for heavy cigarette smokers not to be screened. We identified 10 critical components in implementing a LS program. We provided the details of each of these components for the two healthcare systems. Most importantly, is that continual re-evaluation of the screening program is needed based on the ongoing quality assurance program and database of the actual screenings. At minimum, there should be an annual review and updating. As early diagnosis of lung cancer must be followed by optimal treatment to be effective, treatment advances for small, early lung cancers diagnosed as a result of screening also need to be assessed and incorporated into the entire screening and treatment program.

5. China pubmed.ncbi.nlm.nih.gov

[Pulmonary Nodules/Lung Cancer Comprehensive Management Mode: Design and Application]. [2021] Mortality of lung cancer can be decreased by early screening effectively. However, consistent and proficient standards & methods have not been established in China. This study was based on pulmonary nodules/lung cancer comprehensive management platform established by West China Hospital, Sichuan University. Early screening of pulmonary nodules was integrated into standard healthcare of lung cancer system, aiming to improve survivals of lung cancer patients.

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

Lung cancer screening. [2021] Lung cancer is the leading cause of cancer death. Although smoking prevention and cessation programs have decreased lung cancer mortality, there remains a large at-risk population. Dismal long-term survival rates persist despite improvements in diagnosis, staging, and treatment. Early efforts to identify an effective screening test have been unsuccessful. Recent advances in multidetector computed tomography have allowed screening studies using low-dose computed tomography (LDCT) to be performed. This set the stage for the National Lung Screening Trial that found that annual LDCT screening benefits individuals at high risk for lung cancer. An understanding of the harmful effects of lung cancer screening is required to help maximize the benefits and decrease the risks of a lung cancer screening program. Although many questions remain regarding LDCT screening, a comprehensive lung cancer screening program of high-risk individuals will increase detection of preclinical and potentially curable disease, creating a new model of lung cancer surveillance and management.

7. England pubmed.ncbi.nlm.nih.gov

Overcoming barriers to lung cancer screening using a systemwide approach with additional focus on the non-screened. [2023] The lung cancer screening program at St Elizabeth Healthcare (Kentucky, USA) began in 2013. Over 33,000 low-dose computed tomography lung cancer screens have been performed. From 2015 through 2021, 2595 lung cancers were diagnosed systemwide. A Screening Program with Impactful Results from Early Detection, reviews that experience; 342 (13.2%) were diagnosed by screening and 2253 (86.8%) were non-screened. As a secondary objective, the non-screened cohort was queried to determine how many additional individuals could have been screened, identifying barriers and failures to meet eligibility.

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

Obstacles to and Solutions for a Successful Lung Cancer Screening Program. [2018] Lung cancer screening with a low radiation dose chest CT scan has been shown to reduce the number of people, in a well-defined very high-risk cohort, who die from lung cancer. Many potential screening-related harms have been identified, including anxiety and morbidity related to the evaluation of screen-detected findings. A favorable balance of the benefit and harms of lung cancer screening requires careful implementation of a screening program, with a focus on several obstacles to the success of the program. In this review, evidence to support the benefit and harms of lung cancer screening is provided, followed by a discussion of 11 obstacles to the development of a high-quality program. For each obstacle, an approach is suggested, based on evidence and mandates as well as practicality and lessons learned. The approach to each of these obstacles highlights the multi-disciplinary nature of lung cancer screening, and the value of considering lung cancer screening a program rather than a test.

9. Switzerland pubmed.ncbi.nlm.nih.gov

[Lung cancer screening in Switzerland : Who ? How ? When ?] [2020] Professional societies encourage the establishment of coordinated national screening programs for lung cancer by « low-dose » chest CT scans. The interdisciplinary Swiss Lung Cancer Screening Implementation Group (CH-LSIG) is exploring the feasibility of such a project. However, several questions still remain unanswered, namely the -financing of such a program, the ideal « number-needed to screen », the definition and follow-up of « positive cases », as well as the role of smoking cessation measures. The key points to discuss in the future with patients requesting screening are based on the « shared -decision-making » approach. Pilot projects guided by the CH-LSIG could help to identify the optimal strategy for establishing a national screening program based on the best available scientific evidence.

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

Impact of a Hybrid Lung Cancer Screening Model on Patient Outcomes and Provider Behavior. [2021] Lung cancer screening (LCS) implementation is complicated by the Centers for Medicare and Medicaid Services reimbursement requirements of shared decision-making and tobacco cessation counseling. LCS programs can utilize different structures to meet these requirements, but the impact of programmatic structure on provider behavior and screening outcomes is poorly described.