N/A
N=135
Patient-Centered Cancer Prevention In Chinese Americans
H. Pylori Infection
Bottom Line
View on ClinicalTrials.gov: NCT03340454 ↗Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Number of Participants With Eradication of H. Pylori (ITT) — 49; 54 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test-and-treat EHR-CHW intervention (Other); Usual care of EHR-only intervention (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Eradication of H. Pylori (ITT) |
49; 54 | — |
| SECONDARY Number of Participants With Eradication of H. Pylori (Clinically Confirmed) |
49; 54 | — |
| SECONDARY Change in Ottawa Decision Self-Efficacy Scale Score From Baseline to 6 Months |
5; 5.7 | — |
| SECONDARY Change in Medication Adherence Report Scale (MARS-5) Score From Baseline to Month 6 |
0.58; 0.77 | — |
| SECONDARY Change in Stomach Cancer Knowledge Between Baseline and 6-months |
1.58; 3.25 | — |
| SECONDARY Change in H. Pylori Knowledge Between Baseline and 6-months |
1.03; 2.56 | — |
| SECONDARY Change in PROMIS Global Physical Health T-Score Between Baseline and 6-months |
-1.1; 1.27 | — |
| SECONDARY Change in PROMIS Global Mental Health T-Score Between Baseline and 6-months |
0.69; 3.13 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03340454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.