Clinical trial NCT03340454: Patient-Centered Cancer Prevention In Chinese Americans
Official title: Patient-Centered Cancer Prevention In Chinese Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: H. Pylori Infection
Keywords: H. pylori
H. pylori infection
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2017-11-13
Enrollment: 135
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Number of Participants With Eradication of H. Pylori (ITT)
timeFrame: Up to Month 3-Post Treatment
Secondary outcomes:
measure: Number of Participants With Eradication of H. Pylori (Clinically Confirmed)
timeFrame: Up to Month 3-Post Treatment
measure: Change in Ottawa Decision Self-Efficacy Scale Score From Baseline to 6 Months
timeFrame: Baseline, Month 6
measure: Change in Medication Adherence Report Scale (MARS-5) Score From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: Change in Stomach Cancer Knowledge Between Baseline and 6-months
timeFrame: Baseline, Month 6
measure: Change in H. Pylori Knowledge Between Baseline and 6-months
timeFrame: Baseline, Month 6
measure: Change in PROMIS Global Physical Health T-Score Between Baseline and 6-months
timeFrame: Baseline, Month 6
measure: Change in PROMIS Global Mental Health T-Score Between Baseline and 6-months
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Simona Kwon, DrPH,MPH
role: PRINCIPAL_INVESTIGATOR
References: