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

Early Phase 1

Active, not recruiting

• Conditions: Lung Cancer Screening; Current or Past Cigarette Smoker
• Interventions: Behavioral: Surveys; Behavioral: Focus groups; Behavioral: In-depth interviews; Behavioral: Navigation

• Registration Number: NCT02914899
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 99

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pilot RCT Control Group	Surveys	Eligible NYC Chinese livery drivers will receive written materials only
Pilot RCT CHW Intervention Group	Surveys	Eligible NYC Chinese livery drivers will receive written materials and navigation for shared decision making (SDM) and lung cancer screening (LCS).
Pilot RCT CHW Intervention Group	Navigation	Eligible NYC Chinese livery drivers will receive written materials and navigation for shared decision making (SDM) and lung cancer screening (LCS).
Pre-pilot Group	Surveys	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
Pre-pilot Group	Navigation	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
Focus Group	Focus groups	The investigators conducted a series of 4-6 focus groups with Chinese livery drivers who (currently, or in the past) smoke.
In-Depth Interview Group	In-depth interviews	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States