Patient-Centered Cancer Prevention In Chinese Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Number of Participants With Eradication of H. Pylori (ITT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of Participants With Eradication of H. Pylori (ITT)
时间窗: 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. Includes positive results for those with self-reported or missing results.
次要结局
- Number of Participants With Eradication of H. Pylori (Clinically Confirmed)(Up to Month 3-Post Treatment)
- Change in H. Pylori Knowledge Between Baseline and 6-months(Baseline, Month 6)
- Change in Medication Adherence Report Scale (MARS-5) Score From Baseline to Month 6(Baseline, Month 6)
- Change in Stomach Cancer Knowledge Between Baseline and 6-months(Baseline, Month 6)
- Change in PROMIS Global Physical Health T-Score Between Baseline and 6-months(Baseline, Month 6)
- Change in PROMIS Global Mental Health T-Score Between Baseline and 6-months(Baseline, Month 6)
- Change in Ottawa Decision Self-Efficacy Scale Score From Baseline to 6 Months(Baseline, Month 6)