Patient-Centered Cancer Prevention In Chinese Americans

Study Overview
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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.

Official Title
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Patient-Centered Cancer Prevention In Chinese Americans

Conditions
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Diabetes

Intervention / Treatment
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* Other: Test-and-treat EHR-CHW intervention
* Other: Usual care of EHR-only intervention


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Health systems-level intervention<br>using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; | Other: Test-and-treat EHR-CHW intervention<br>* a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies<br>|
| Active Comparator: CHW-led patient navigation program<br>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<br>* a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Eradication of H. pylori | Measured using breath ammonia measurement, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test. Data extracted from patient EHR. | Up to Month 3-Post Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ottawa Decision Self-Efficacy Scale Score at Baseline | 11- item assessment of participant's confidence in making an informed choice. For each item, confidence is rated on a 5-point Likert scale from 0 (not at all confident) to 4 (very confident). The total score is the sum of responses and ranges from 0 to 44; higher scores indicate greater decision self-efficacy. | Baseline | 
| Ottawa Decision Self-Efficacy Scale Score at Month 2 | 11- item assessment of participant's confidence in making an informed choice. For each item, confidence is rated on a 5-point Likert scale from 0 (not at all confident) to 4 (very confident). The total score is the sum of responses and ranges from 0 to 44; higher scores indicate greater decision self-efficacy. | Month 2 | 
| Ottawa Decision Self-Efficacy Scale Score at Month 6 | 11- item assessment of participant's confidence in making an informed choice. For each item, confidence is rated on a 5-point Likert scale from 0 (not at all confident) to 4 (very confident). The total score is the sum of responses and ranges from 0 to 44; higher scores indicate greater decision self-efficacy. | Month 6 | 
| Number of Patients determined to be Adherent per Medication Adherence Report Scale (MARS-5) Score at Baseline | The MARS-5 is a 5-item self-assessment of medication adherence. The first item assesses unintentional non-adherence, while the four other items assess intentional non-adherence. Participants indicated how often each statement applied to them in the past month on a 5-point Likert scale (1=always, 2=often, 3=sometimes, 4=rarely, 5=never), resulting in a total score ranging from 5 to 25. Non-adherence is defined as reporting any non-adherence on the MARS (total score <25). Adherence is defined as a score of 25. | Baseline | 
| Number of Patients determined to be Adherent per MARS-5 Score at Month 2 | The MARS-5 is a 5-item self-assessment of medication adherence. The first item assesses unintentional non-adherence, while the four other items assess intentional non-adherence. Participants indicated how often each statement applied to them in the past month on a 5-point Likert scale (1=always, 2=often, 3=sometimes, 4=rarely, 5=never), resulting in a total score ranging from 5 to 25. Non-adherence is defined as reporting any non-adherence on the MARS (total score <25). Adherence is defined as a score of 25. | Month 2 | 
| Number of Patients determined to be Adherent per MARS-5 Score at Month 6 | The MARS-5 is a 5-item self-assessment of medication adherence. The first item assesses unintentional non-adherence, while the four other items assess intentional non-adherence. Participants indicated how often each statement applied to them in the past month on a 5-point Likert scale (1=always, 2=often, 3=sometimes, 4=rarely, 5=never), resulting in a total score ranging from 5 to 25. Non-adherence is defined as reporting any non-adherence on the MARS (total score <25). Adherence is defined as a score of 25. | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H. pylori, H. pylori infection