- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03340454
Patient-Centered Cancer Prevention In Chinese Americans
March 19, 2024 updated by: NYU Langone Health
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
135
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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;
|
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
|
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
Time Frame: Up to Month 3-Post Treatment
|
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Simona Kwon, DrPH,MPH, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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