Patient-Centered Cancer Prevention In Chinese Americans

NCT ID: NCT03340454

Last Updated: 2024-07-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2023-06-15

Brief Summary

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This study will assess the efficacy, adoption, and impact of an integrated intervention to improve adherence to recommended stomach cancer prevention guidelines (H. pylori test-and-treat) for at-risk Chinese Americans in NYC. The integrated multifaceted theory-based intervention involves: 1) a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; and 2) a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability. Using a 2-arm randomized controlled trial (RCT) design, \> 144 Chinese American patients across NYC safety net hospital endoscopy clinics and primary health centers will participate.

Detailed Description

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Conditions

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H. Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Health systems-level intervention

using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;

Group Type ACTIVE_COMPARATOR

Test-and-treat EHR-CHW intervention

Intervention Type OTHER

a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies

CHW-led patient navigation program

a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability

Group Type ACTIVE_COMPARATOR

Usual care of EHR-only intervention

Intervention Type OTHER

a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability.

Interventions

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Test-and-treat EHR-CHW intervention

a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies

Intervention Type OTHER

Usual care of EHR-only intervention

a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* self identifies as Chinese American
* is an outpatient aged 21 years and older (adult)
* plans to continue to live in the region during the next 12 months;
* is willing to be randomized to either treatment or control groups
* has a confirmed diagnosis of H. pylori infection by at least one of the following methods: C-urea breath test, histology, rapid urease test or bacterial culture, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test.

Exclusion Criteria

* advanced chronic disease that would not allow the patient to complete follow-up or attend visits;
* allergy to any of the study drugs;
* pregnancy or currently breastfeeding
* taking antibiotics or bismuth salts within 2 weeks before the study.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simona Kwon, DrPH,MPH

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2U54MD000538

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-01446

Identifier Type: -

Identifier Source: org_study_id

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