Patient-Centered Cancer Prevention In Chinese Americans

NYU Langone Health

Status: Completed

Conditions: H. Pylori Infection

Treatments: Other: Usual care of EHR-only intervention; Other: Test-and-treat EHR-CHW intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03340454

2U54MD000538 (U.S. NIH Grant/Contract)

17-01446

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

135 participants in 2 patient groups

Health systems-level intervention

Active Comparator group

Description:

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

Treatment:

Other: Test-and-treat EHR-CHW intervention

CHW-led patient navigation program

Active Comparator group

Description:

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

Treatment:

Other: Usual care of EHR-only intervention