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

January 4, 2024 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

99

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pilot RCT Control Group
Eligible NYC Chinese livery drivers will receive written materials only

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.

Experimental: 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).

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.

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.
Experimental: Focus Group
The investigators conducted a series of 4-6 focus groups with Chinese livery drivers who (currently, or in the past) smoke.
Gained drivers' perspectives on adapting the community health worker (CHW) model to facilitate lung cancer screening (LCS).
Experimental: 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.

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.

Experimental: 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

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.

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jennifer Leng, MD, MPH, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimated)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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