Patient-Centered Cancer Prevention In Chinese Americans

NCT03340454 | Completed Results

• 2 other identifiers: 17-014462U54MD000538
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

H. Pylori Infection

Keywords

H. pylori; H. pylori infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Eradication of H. Pylori (ITT)

  Measured using breath ammonia measurement, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test. Data extracted from patient EHR. Includes positive results for those with self-reported or missing results.

  Up to Month 3-Post Treatment

Secondary Outcomes (7)

• Number of Participants With Eradication of H. Pylori (Clinically Confirmed)

  Up to Month 3-Post Treatment

• Change in Ottawa Decision Self-Efficacy Scale Score From Baseline to 6 Months

  Baseline, Month 6

• Change in Medication Adherence Report Scale (MARS-5) Score From Baseline to Month 6

  Baseline, Month 6

• Change in Stomach Cancer Knowledge Between Baseline and 6-months

  Baseline, Month 6

• Change in H. Pylori Knowledge Between Baseline and 6-months

  Baseline, Month 6

Study Arms (2)

Health systems-level intervention

ACTIVE COMPARATOR

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

Other: Test-and-treat EHR-CHW intervention

CHW-led patient navigation program

ACTIVE COMPARATOR

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

Other: Usual care of EHR-only intervention

Interventions

Test-and-treat EHR-CHW intervention OTHER

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

Health systems-level intervention

Usual care of EHR-only intervention OTHER

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

CHW-led patient navigation program

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Results Point of Contact

• Title: Yi-Ling Tan
• Organization: NYU Langone Health

yi-ling.tan@nyulangone.org

646-501-3489

Study Officials

• Simona Kwon, DrPH,MPH

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 13, 2017
• Study Start: August 15, 2018
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-07

Locations

US (1)