Community Health Worker Program for Lung Cancer Screening

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Household member participated, 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 aims to determine if a Community Health Worker program can better assist at-risk Chinese community members in New York City with lung cancer screening compared to providing only written materials. The study focuses on simplifying the decision-making process for participants regarding screening options and lung health. Participants include Chinese livery drivers who currently smoke or have quit within the last 15 years and have a history of heavy smoking. The trial will compare different support methods, such as focus groups, navigation (guidance and support through the healthcare system), and interviews with community members and healthcare professionals. As an Early Phase 1 trial, this research seeks to understand how the intervention works in people, offering participants a chance to contribute to groundbreaking community health strategies.

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. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Community Health Worker program is safe for the NYC Chinese community?

Research has shown that patient navigation, the focus of this trial, has been safely used in other studies. One study found that navigation programs increased lung cancer screening among high-risk smokers without major safety concerns. Another study demonstrated that patient navigation effectively helped people experiencing homelessness participate in lung cancer screening.

Since this trial is in an early phase, it primarily examines the program's effectiveness rather than safety. However, patient navigation has been successfully used in other contexts, suggesting it is generally well-tolerated. Available research reports no major problems related to this type of program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to enhance lung cancer screening among Chinese livery drivers, a group that might face unique challenges in accessing healthcare. Unlike traditional methods that often rely solely on written materials, this trial introduces navigation support to assist in shared decision-making and lung cancer screening. By involving community health workers, the trial aims to improve understanding and participation in screening processes, potentially leading to earlier detection and better outcomes. The focus on culturally tailored interventions and direct community engagement could set a new standard for cancer screening practices in similar populations.

What evidence suggests that this trial's treatments could be effective for lung cancer screening?

Research has shown that lung cancer screening can reduce the risk of dying from lung cancer by 20%. However, many eligible individuals do not undergo this screening. In this trial, one group of participants will receive navigation support from community health workers to guide them through the decision-making and screening process. Studies have found that community health workers increase the number of people who complete the screening. For instance, one study found that 23.5% of people completed screening with guidance, compared to just 8.6% without it. This suggests that assistance significantly increases the likelihood of getting screened. ^{2 6 7 8 9}

Who Is on the Research Team?

Jennifer Leng, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for Chinese community members in NYC who are at risk for lung cancer. It includes male professional drivers aged 50-80, fluent in Mandarin or Cantonese, with a history of heavy smoking. Healthcare providers and livery staff fluent in English or Mandarin can also participate. Participants must not plan to leave the New York area for extended periods during the study.

Inclusion Criteria

I am a male professional driver of Chinese descent, aged 50-80, who smokes or recently quit.

I am a health care provider or administrator, over 21, and speak English fluently.

I am a male, Mandarin-speaking Chinese livery driver aged 55-80, with a smoking history, living in New York.

Exclusion Criteria

Has a household member who has already participated (or agreed to participate)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-pilot

Refinement of adapted CHW intervention materials and assessment of feasibility

12 months

Multiple visits for workshops and assessments

Pilot

Pilot randomized controlled trial to assess the feasibility of the refined CHW model versus written materials

6 months

Multiple visits for intervention and control assessments

Follow-up

Participants are monitored for increased uptake in shared decision making and lung cancer screening

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Focus groups
• In-depth interviews
• Navigation
• Surveys

Trial Overview The study tests if a Community Health Worker program improves participation in lung cancer screening and decision-making compared to just providing written materials. The methods include surveys, navigation assistance, focus groups, and interviews among eligible participants.

How Is the Trial Designed?

Group I: Pre-pilot Group Experimental Treatment 2 Interventions

Approximately 10 Chinese livery drivers who smoke or who quit smoking with the past 15 years and have a 30 pack-year history of smoking

Group II: Pilot RCT CHW Intervention Group Experimental Treatment 2 Interventions

Eligible NYC Chinese livery drivers will receive written materials and navigation for shared decision making (SDM) and lung cancer screening (LCS).

Group III: In-Depth Interview Group Experimental Treatment 1 Intervention

12-15 in-depth interviews with livery base management and staff, and with 12-15 primary care physicians (PCPs), clinic directors, hospital CFOs, heads of financial services and counseling, and heads of radiology facilities serving the Chinese community.

Group IV: Focus Group Experimental Treatment 1 Intervention

The investigators conducted a series of 4-6 focus groups with Chinese livery drivers who (currently, or in the past) smoke.

Group V: Pilot RCT Control Group Active Control 1 Intervention

Eligible NYC Chinese livery drivers will receive written materials only

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10922311/

Unpacking the Relationship Between Shared Decision ... Higher decisional quality is associated with both the decision to get screened and screening completion, and findings from this study support knowledge of lung ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2819341

Lung Cancer Screening Decisions and Environmental ... This qualitative study investigates environmental, psychosocial, and modifying factors in lung cancer screening decisions among US patients ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK616278/

RESULTS - Shared Decision-Making for Lung Cancer ... Authors found that 23.5% of the intervention arm completed LCS, compared with 8.6% of usual care (p < 0.001) Results did not differ by race, sex, or age ...

4. neimanhpi.org neimanhpi.org/press-releases/current-and-past-smokers-who-talk-to-their-doctor-about-lung-cancer-screening-far-more-likely-to-be-tested-as-recommended-over-time/

Doctor-led Shared Decision-Making Significantly Boosts ... “We found that patients who had a shared decision-making visit with their provider were more likely to remain engaged with lung cancer screening ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0738399125006706

Navigating shared decision-making in lung cancer screening Shared decision-making (SDM) is critical in lung cancer screening (LCS), enabling clinicians to guide patients through complex benefit-risk discussions. Despite ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6890387/

Defining the information needs of lung cancer screening ... We carried out seven focus groups with screening-eligible individuals, which were divided into current versus former smokers and lower versus ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1556086423016659

EP04.06 SCREENING AND EARLY DETECTION We explored people's perception of early diagnosis methods and early symptoms of cancer important components of lung cancer screening.

8. ahrq.gov ahrq.gov/news/newsletters/e-newsletter/924.html

Intervention Leads to Increase in Lung Cancer Screenings Lung cancer screening rates increased due to a multifaceted intervention, which included clinician reminders, shared decision-making tools and patient ...

9. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00082-8/fulltext

Low-dose CT for lung cancer screening in a high-risk ... Low-dose CT screening reduces lung cancer mortality. In advance of planned national lung cancer screening programmes, research is needed to ...