Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02914899
Recruitment Status : Enrolling by invitation
First Posted : September 26, 2016
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Screening Current or Past Cigarette Smoker Behavioral: Surveys Behavioral: Navigation Behavioral: Focus groups Behavioral: In-depth interviews Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Informing the Adaptation of a CHW Model to Facilitate Lung Cancer Screening for the Chinese Community
Study Start Date : August 2016
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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


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).
Behavioral: 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.


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.

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


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
Behavioral: 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.


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.




Primary Outcome Measures :
  1. (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. (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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914899


Locations
Layout table for location information
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Jennifer Leng, MD, MPH Memorial Sloan Kettering Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02914899    
Other Study ID Numbers: 16-949
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021
Keywords provided by Memorial Sloan Kettering Cancer Center:
Professional Drivers
16-949
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases