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

NCT ID: NCT02914899

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2025-11-19

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.

Conditions

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Lung Cancer Screening Current or Past Cigarette Smoker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Pilot RCT Control Group

Eligible NYC Chinese livery drivers will receive written materials only

Group Type ACTIVE_COMPARATOR

Surveys

Intervention Type BEHAVIORAL

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.

Pilot RCT CHW Intervention Group

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

Group Type EXPERIMENTAL

Surveys

Intervention Type BEHAVIORAL

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.

Navigation

Intervention Type BEHAVIORAL

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.

Focus Group

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

Group Type EXPERIMENTAL

Focus groups

Intervention Type BEHAVIORAL

Gained drivers' perspectives on adapting the community health worker (CHW) model to facilitate lung cancer screening (LCS).

In-Depth Interview Group

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 Type EXPERIMENTAL

In-depth interviews

Intervention Type BEHAVIORAL

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.

Pre-pilot Group

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 Type EXPERIMENTAL

Surveys

Intervention Type BEHAVIORAL

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.

Navigation

Intervention Type BEHAVIORAL

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.

Interventions

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Surveys

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.

Intervention Type BEHAVIORAL

Navigation

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.

Intervention Type BEHAVIORAL

Focus groups

Gained drivers' perspectives on adapting the community health worker (CHW) model to facilitate lung cancer screening (LCS).

Intervention Type BEHAVIORAL

In-depth interviews

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.

Intervention Type BEHAVIORAL

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).
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Leng, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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16-949

Identifier Type: -

Identifier Source: org_study_id

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