Patient-Centered Cancer Prevention In Chinese Americans

Keywords

• H. pylori
• H. pylori infection

Lead sponsor

NYU Langone Health is the lead sponsor of 1,421 studies on the registry; 254 are open to participants now.

Of its 231 completed or terminated interventional studies of FDA-regulated products, 195 (84%) have results posted.

Study arms

• 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

• 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

Interventions

• OtherTest-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

• OtherUsual 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.

Primary outcomes

1. 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.

   Time frame: Up to Month 3-Post Treatment

Secondary outcomes

1. 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.

   Time frame: Up to Month 3-Post Treatment

2. 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.

   Time frame: Baseline, Month 6

3. 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.

   Time frame: Baseline, Month 6

4. 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)

   Time frame: Baseline, Month 6

5. 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)

   Time frame: Baseline, Month 6

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.

   Time frame: Baseline, Month 6

7. 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.

   Time frame: Baseline, Month 6

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · May 9, 2023

Documents are hosted by the registry — open the source record to download them.