Patient-Centered Cancer Prevention In Chinese Americans

H. Pylori Infection Clinical Trial

Official title:

Patient-Centered Cancer Prevention In Chinese Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340454
• Other study ID #: 17-01446
• Secondary ID: 2U54MD000538
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: June 15, 2023

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• H. Pylori Infection
• Helicobacter Infections
• Infections

Intervention

Other:
• Test-and-treat EHR-CHW intervention
a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies
• Usual care of EHR-only intervention
a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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