Patient-Centered Cancer Prevention In Chinese Americans

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.

Study Overview

• Status: Completed
• Conditions: H. Pylori Infection
• Intervention / Treatment: Other: Test-and-treat EHR-CHW intervention; Other: Usual care of EHR-only intervention

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Eradication of H. Pylori (Clinically Confirmed)	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
Change in Ottawa Decision Self-Efficacy Scale Score From Baseline to 6 Months	Participants completed the Ottawa Decision Self-Efficacy Scale, which assessed participants' confidence in making an informed choice, at baseline and 6-month follow-up. The scale consists of 11 questions on a 5-point Likert scale from 0 (not at all confident) to 4 (very confident). The raw score is the sum of responses. The raw score is converted to a standardized total score that ranges from 0 to 100; higher total scores indicate greater decision self-efficacy.	Baseline, Month 6
Change in Medication Adherence Report Scale (MARS-5) Score From Baseline to Month 6	Participants completed the MARS-5 self-assessment of medication adherence at baseline and 6-month follow-up. One item assessed unintentional non-adherence, while four items assessed 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. Adherence is defined as a score of 25.	Baseline, Month 6
Change in Stomach Cancer Knowledge Between Baseline and 6-months	Participants were asked about associations with the risk of getting stomach cancer (alcohol, spicy food, stress, family history, h. pylori infection, smoking, salty food, being physically inactive, pickled food, food high in sugar). True or false was chosen. Variables were recoded to correct (1) and incorrect (0), and summed for a final score (0-10, 10=highest knowledge)	Baseline, Month 6
Change in H. Pylori Knowledge Between Baseline and 6-months	Participants were asked about associations with h. pylori (blood, untreated/contaminated water, rats, mosquitoes, contaminated food, vomit, poor sanitation). True or false was chosen. Variables were recoded to correct (1) and incorrect (0), and summed for a final score (0-7, 7=highest knowledge)	Baseline, Month 6
Change in PROMIS Global Physical Health T-Score Between Baseline and 6-months	Participants completed the PROMIS Global Physical Health Scale, which assessed participants' physical health, at baseline and 6-month follow-up. Four questions assessed global physical health. Three questions were administered using five-category response scales, and one item used a response scale of 0-10 that was recoded to five categories. Responses are recoded into t-scores, which rescales the raw sum score into a standardized score from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the concept being measured.	Baseline, Month 6
Change in PROMIS Global Mental Health T-Score Between Baseline and 6-months	Participants completed the PROMIS Global Mental Health Scale, which assessed participants' mental health, at baseline and 6-month follow-up. Four questions assessed global mental health, and all were administered using five-category response scales. Responses are recoded into t-scores, which rescales the raw sum score into a standardized score from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the concept being measured.	Baseline, Month 6

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Simona Kwon, DrPH,MPH, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: H. pylori; H. pylori infection
• Additional Relevant MeSH Terms: Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Helicobacter Infections
• Other Study ID Numbers: 17-01446; 2U54MD000538 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No