Informing the Adaptation of a CHW Model to Facilitate Lung Cancer Screening for the Chinese Community

Study Overview
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Brief Summary
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The purpose of this study is to test if our Community Health Worker program can help at-risk NYC Chinese community members participate in shared decision making and lung cancer screening (if appropriate) and compare it to the help provided by written materials.

Detailed Description
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The study first used qualitative methods to inform the adaptation of a CHW model to facilitate lung cancer screening completion in an extremely high-risk group, NYC Chinese livery drivers who smoke or who quit within the past 15 years. A series of focus groups with Chinese livery drivers who smoke, a series of in-depth interviews with livery base management and staff, primary care physicians (PCPs), clinic directors, hospital CFOs, heads of financial services and counseling, and heads of radiology facilities serving the Chinese community were conducted to explore barriers and factors related to cancer screening. Findings were used to develop adapted intervention materials, including a CHW Manual for Facilitating Shared Decision Making and Lung Cancer Screening. Once adaptation is complete, the researchers will conduct a pre-pilot to refine the adapted CHW intervention materials. The researchers will then conduct a pilot randomized controlled trial (RCT) to assess the feasibility of the refined CHW model (intervention) versus written materials (control) to facilitate SDM and LCS (when appropriate) in an extremely high-risk group, NYC Chinese livery drivers eligible (by USPTSF criteria) for LCS. Feasibility results will be used to inform the planning and design of large scale RCTs, targeting Chinese drivers, as well as other driver populations in NYC and throughout the U.S., and other high risk Chinese smoking populations in other occupations (e.g. restaurant work, construction). The study is currently in the pre-pilot phase and expects to launch the pilot phase by the summer of 2020. Due to the effects of the COVID-19 crisis, the researchers have extended the pre-pilot participation time frame to 12 months. The study population has also indicated concern to attend doctor's appointments for SDM/LCS during COVID-19. As such, MSK is extending the study time frame to an additional 6 months. . CHWs will also be hosting health education workshops at community organizations, family associations, and public libraries. These workshops will be conducted in English, Mandarin, and Cantonese and cover topics including smoking cessation and lung cancer screening.

Official Title
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Informing the Adaptation of a CHW Model to Facilitate Lung Cancer Screening for the Chinese Community

Conditions
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Lung Cancer Screening, Current or Past Cigarette Smoker

Intervention / Treatment
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* Behavioral: Surveys
* Behavioral: Navigation
* Behavioral: Focus groups
* Behavioral: In-depth interviews


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Focus Group Participants: Of Chinese descent Non-U.S. born Fluent in Mandarin Livery driver Age 45-80 Current or past (within 15 years) cigarette smoker (no specific pack year requirement) In Depth Interview Participants Livery Staff Of Chinese descent Non-U.S. born Fluent in Mandarin Livery base owner or employee Age ≥ 21 Health Care Providers and Administrators: Primary care physician, clinic director, hospital administrator, or radiology facility or department administrator Age ≥ 21 Fluent in English CHW pre-pilot RCT participants: Of Chinese descent Fluent in Mandarin Male Livery driver Age 55-80 years old Driven for 3 months or longer 30 pack year history Current smoker or quit within 15 years Will not be traveling out of New York Area for more than 1 month in the next 3 months CHW pilot RCT participants Of Chinese descent Fluent in Mandarin or Cantonese Male Professional driver Age 50-80 years old Driven for 3 months or longer Last drove professionally within the last 18 months with plans of returning 20 pack year smoking history Current smoker or quit within 15 years Will not be traveling out of New York Area for more than 3 months in the next 12 months Has not completed LDCT in the past year. Exclusion Criteria: Has a household member who has already participated (or agreed to participate).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pilot RCT Control Group<br>Eligible NYC Chinese livery drivers will receive written materials only | Behavioral: Surveys<br>* Intake surveys recorded demographics, workplace profile, financial profile, health care access, cancer screening behavior, medical history, etc. Exit surveys asked whether drivers received shared decision making (SDM) counseling, completed LCS (low-dose computed tomography [LDCT] scan), had barriers, felt satisfied, etc.<br>|
| Experimental: Pilot RCT CHW Intervention Group<br>Eligible NYC Chinese livery drivers will receive written materials and navigation for shared decision making (SDM) and lung cancer screening (LCS). | Behavioral: Surveys<br>* Intake surveys recorded demographics, workplace profile, financial profile, health care access, cancer screening behavior, medical history, etc. Exit surveys asked whether drivers received shared decision making (SDM) counseling, completed LCS (low-dose computed tomography [LDCT] scan), had barriers, felt satisfied, etc.<br>Behavioral: Navigation<br>* CHWs facilitated SDM and LCS for drivers, providing navigation ( finding a PCP, scheduling appointments, assisting with insurance, etc.), following up on results and next steps.<br>|
| Experimental: Focus Group<br>The investigators conducted a series of 4-6 focus groups with Chinese livery drivers who (currently, or in the past) smoke. | Behavioral: Focus groups<br>* Gained drivers' perspectives on adapting the community health worker (CHW) model to facilitate lung cancer screening (LCS).<br>|
| Experimental: In-Depth Interview Group<br>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. | Behavioral: In-depth interviews<br>* Interviews with Chinese livery bases elicited perspectives on adapting the CWH model for the drivers' occupational environment. Interviews with PCPs, clinic directors, etc. serving Chinese communities provided insight into adapting the CHW model within the health care context.<br>|
| Experimental: Pre-pilot Group<br>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 | Behavioral: Surveys<br>* Intake surveys recorded demographics, workplace profile, financial profile, health care access, cancer screening behavior, medical history, etc. Exit surveys asked whether drivers received shared decision making (SDM) counseling, completed LCS (low-dose computed tomography [LDCT] scan), had barriers, felt satisfied, etc.<br>Behavioral: Navigation<br>* CHWs facilitated SDM and LCS for drivers, providing navigation ( finding a PCP, scheduling appointments, assisting with insurance, etc.), following up on results and next steps.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Pre-Pilot Phase) Increased uptake in SDM and LCS | To determine whether participation in the interventions leads to increased completion of SDM and LCS with LDCT. | 2 years | 
| (Pilot Phase) Increased uptake in SDM and LCS | To determine whether participation in the interventions leads to increased completion of SDM and LCS with LDCT. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Professional Drivers, 16-949