NCT02914899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2016

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2025

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

9.3 years

First QC Date

September 21, 2016

Last Update Submit

November 19, 2025

Conditions

Keywords

Professional Drivers16-949

Outcome Measures

Primary Outcomes (2)

  • (Pre-Pilot Phase) Increased uptake in SDM and LCS

    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

    To determine whether participation in the interventions leads to increased completion of SDM and LCS with LDCT.

    2 years

Study Arms (5)

Pilot RCT Control Group

ACTIVE COMPARATOR

Eligible NYC Chinese livery drivers will receive written materials only

Behavioral: Surveys

Pilot RCT CHW Intervention Group

EXPERIMENTAL

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

Behavioral: SurveysBehavioral: Navigation

Focus Group

EXPERIMENTAL

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

Behavioral: Focus groups

In-Depth Interview Group

EXPERIMENTAL

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

Pre-pilot Group

EXPERIMENTAL

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: SurveysBehavioral: Navigation

Interventions

SurveysBEHAVIORAL

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 GroupPilot RCT Control GroupPre-pilot Group
NavigationBEHAVIORAL

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.

Pilot RCT CHW Intervention GroupPre-pilot Group
Focus groupsBEHAVIORAL

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

Focus Group

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.

In-Depth Interview Group

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +24 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Interventions

Surveys and QuestionnairesFocus Groups

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jennifer Leng, MD, MPH

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 26, 2016

Study Start

August 1, 2016

Primary Completion

November 19, 2025

Study Completion

November 19, 2025

Last Updated

November 21, 2025

Record last verified: 2025-11

Locations