Clinical trial NCT02914899: Informing the Adaptation of a CHW Model to Facilitate Lung Cancer Screening for the Chinese Community
Official title: Informing the Adaptation of a CHW Model to Facilitate Lung Cancer Screening for the Chinese Community
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Lung Cancer Screening
Current or Past Cigarette Smoker
Keywords: Professional Drivers
16-949
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 99
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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).

Primary outcomes:
measure: (Pre-Pilot Phase) Increased uptake in SDM and LCS
timeFrame: 2 years
measure: (Pilot Phase) Increased uptake in SDM and LCS
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jennifer Leng, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: