Centralized Patient Outreach for Lung Cancer Screening

(CLEAR Trial)

Overseen By Jialin Mao, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Age, Smoking history, LDCT scan, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how centralized outreach can increase the completion of lung cancer screenings. It focuses on current or former smokers who haven't recently had a specific type of lung scan. The trial includes two groups: one receives extra outreach (such as phone calls or mail), while the other receives usual care. Potential participants include patients at Ryan Health in New York City who have not been diagnosed with lung cancer. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance lung cancer screening processes for many.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to check with the trial coordinators for specific guidance.

What prior data suggests that centralized patient outreach for lung cancer screening is safe?

Studies have shown that directly reaching out to patients can effectively increase lung cancer screening rates. This method is safe, using simple communication like phone calls and mail, which are non-invasive.

Research indicates that these outreach programs help more people adhere to their lung cancer screening schedules without harm. No reports of negative effects from the outreach itself suggest that this approach is safe and well-received by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about centralized patient outreach for lung cancer screening because it offers a proactive approach to early detection. Unlike standard care, which relies on patients initiating screenings, this method actively reaches out to individuals to encourage timely lung cancer screenings. By potentially increasing screening rates, this outreach can lead to earlier diagnoses and better outcomes for patients, which is a promising advancement in lung cancer management.

What evidence suggests that centralized patient outreach is effective for lung cancer screening?

Research has shown that centralized patient outreach can significantly increase lung cancer screening rates. In this trial, individuals in the outreach arm will receive centralized patient outreach for lung cancer screening in addition to usual care. One study found that a health system doubled its lung cancer screening rates using CT scans by directly contacting patients. Another study discovered that these centralized programs help individuals adhere to yearly screenings, allowing for earlier detection of lung cancer. Specifically, one program found 77.8% of its lung cancer cases at an early stage. Centralized outreach not only boosts screening rates but also aids in earlier detection, which is crucial for effective treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Jialin Mao, MD, PhD

Principal Investigator

Weill Medical College of Cornell University

Bradley B Pua, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for individuals who are eligible for lung cancer screening, typically due to a history of smoking or other risk factors. They must be served by Federally Qualified Health Centers. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Current or past smokers

Individuals without a recorded LDCT scan within the past year

Active patients of Ryan Health

Exclusion Criteria

Individuals without smoking history

Individuals with a recorded LDCT scan within the past year

Individuals without a mailing address in the New York City area or a phone number on file

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Outreach

Centralized patient outreach through a letter followed by up to three attempts of telephone contact for lung cancer screening

15 months

Follow-up

Participants are monitored for follow-up care, including biopsy or lung cancer treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Centralized patient outreach for lung cancer screening

Trial Overview

The study is testing the effectiveness of centralized patient outreach methods in encouraging people to complete lung cancer screenings.

How Is the Trial Designed?

Group I: Outreach arm Experimental Treatment 1 Intervention

Individuals in the outreach arm will receive centralized patient outreach for lung cancer screening in addition to usual care.

Group II: Usual care arm Active Control 1 Intervention

Individuals in the usual care arm will receive usual care and will not receive any outreach contacts (mail or telephone) within 15 months after randomization.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12489341/

Lung Cancer Screening Adherence in Centralized vs ...

Twelve studies involving 17,195 patients with negative baseline results were included in this meta-analysis. The overall pooled adherence rate in centralized ...

2.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2831670

Adherence to Annual Lung Cancer Screening and Rates of ...

In this study, adherence to annual LCS was associated with an increased lung cancer detection rate but decreased annually after baseline screening.

3.

theimagingwire.com

theimagingwire.com/2025/10/15/one-health-system-doubled-its-ct-lung-cancer-screening-rates/

Doubling Lung Screening Rates with Patient Outreach

A new study shows how one health system doubled its CT lung cancer screening rates – to levels approaching those of more established cancer ...

4.

journal.chestnet.org

journal.chestnet.org/article/S0012-3692(23)03745-5/fulltext

ENHANCING ADHERENCE TO LUNG CANCER ...

Centralizing LCS programs can effectively improve adherence to annual screening visits for patients which may lead to more timely detection of lung cancer.

5.

catalyst.nejm.org

catalyst.nejm.org/doi/abs/10.1056/CAT.25.0051

A Comprehensive, Multidisciplinary Approach to Improving ...

In 2023 and 2024, the program diagnosed 63 cases of lung cancer, of which 49 (77.8%) were diagnosed at an early stage. The program used a well- ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07216144

Centralized Lung Cancer Screening Engagement in At- ...

A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11646683/

Primary care outreach and decision counseling for lung ...

Decision counseling is a promising intervention that might support SDM in the context of improving uptake of lung cancer screening in primary care.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0012369225005598

Lung Cancer Screening Adherence in Centralized vs ...

Our results indicate that adherence to LCS remains low but is significantly higher in centralized screening programs compared with decentralized ones.

9.

hollingscancercenter.musc.edu

hollingscancercenter.musc.edu/news/archive/2022/11/22/largest-ever-lung-cancer-screening-study-reveals-ways-to-increase-screening-outreach

Largest-ever lung cancer screening study reveals ways to ...

Investigators looked at the first million people to be screened for lung cancer in the US to find out who is getting screened - and who isn't.

10.

ajpmonline.org

ajpmonline.org/article/S0749-3797(24)00332-5/abstract

Achieving Equitable Lung Cancer Screening ...

From 11/2020–8/2023, patients aged 55–77 years who currently smoked or quit within 15 years with ≥20 pack-years of exposure were identified ...