Trial Outcomes & Findings for Patient-Centered Cancer Prevention In Chinese Americans (NCT NCT03340454)
NCT ID: NCT03340454
Last Updated: 2024-07-03
Results Overview
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.
COMPLETED
NA
135 participants
Up to Month 3-Post Treatment
2024-07-03
Participant Flow
Participant milestones
| Measure |
Health Systems-level Intervention
using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;
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
|
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
68
|
|
Overall Study
COMPLETED
|
67
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Health Systems-level Intervention
using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;
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
|
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
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
Baseline Characteristics
Patient-Centered Cancer Prevention In Chinese Americans
Baseline characteristics by cohort
| Measure |
Health Systems-level Intervention
n=67 Participants
using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;
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
|
CHW-led Patient Navigation Program
n=64 Participants
a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability
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.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
n=5 Participants
|
42 years
n=7 Participants
|
43.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
67 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=5 Participants
|
64 participants
n=7 Participants
|
131 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Month 3-Post TreatmentMeasured 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.
Outcome measures
| Measure |
Health Systems-level Intervention
n=67 Participants
using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;
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
|
CHW-led Patient Navigation Program
n=64 Participants
a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability
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.
|
|---|---|---|
|
Number of Participants With Eradication of H. Pylori (ITT)
|
49 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Up to Month 3-Post TreatmentMeasured using breath ammonia measurement, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test. Data extracted from patient EHR.
Outcome measures
| Measure |
Health Systems-level Intervention
n=56 Participants
using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;
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
|
CHW-led Patient Navigation Program
n=59 Participants
a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability
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.
|
|---|---|---|
|
Number of Participants With Eradication of H. Pylori (Clinically Confirmed)
|
49 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6Participants 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.
Outcome measures
| Measure |
Health Systems-level Intervention
n=60 Participants
using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;
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
|
CHW-led Patient Navigation Program
n=57 Participants
a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability
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.
|
|---|---|---|
|
Change in Ottawa Decision Self-Efficacy Scale Score From Baseline to 6 Months
|
5 score on a scale
Standard Deviation 13.59
|
5.7 score on a scale
Standard Deviation 11.77
|
SECONDARY outcome
Timeframe: Baseline, Month 6Participants 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.
Outcome measures
| Measure |
Health Systems-level Intervention
n=62 Participants
using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;
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
|
CHW-led Patient Navigation Program
n=57 Participants
a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability
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.
|
|---|---|---|
|
Change in Medication Adherence Report Scale (MARS-5) Score From Baseline to Month 6
|
0.58 score on a scale
Standard Deviation 2.69
|
0.77 score on a scale
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: Baseline, Month 6Participants 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)
Outcome measures
| Measure |
Health Systems-level Intervention
n=60 Participants
using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;
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
|
CHW-led Patient Navigation Program
n=57 Participants
a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability
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.
|
|---|---|---|
|
Change in Stomach Cancer Knowledge Between Baseline and 6-months
|
1.58 score on a scale
Standard Deviation 2.25
|
3.25 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline, Month 6Participants 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)
Outcome measures
| Measure |
Health Systems-level Intervention
n=61 Participants
using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;
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
|
CHW-led Patient Navigation Program
n=59 Participants
a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability
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.
|
|---|---|---|
|
Change in H. Pylori Knowledge Between Baseline and 6-months
|
1.03 score on a scale
Standard Deviation 2
|
2.56 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline, Month 6Participants 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.
Outcome measures
| Measure |
Health Systems-level Intervention
n=61 Participants
using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;
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
|
CHW-led Patient Navigation Program
n=58 Participants
a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability
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.
|
|---|---|---|
|
Change in PROMIS Global Physical Health T-Score Between Baseline and 6-months
|
-1.1 T-score
Standard Deviation 2.71
|
1.27 T-score
Standard Deviation 8.27
|
SECONDARY outcome
Timeframe: Baseline, Month 6Participants 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.
Outcome measures
| Measure |
Health Systems-level Intervention
n=61 Participants
using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;
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
|
CHW-led Patient Navigation Program
n=57 Participants
a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability
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.
|
|---|---|---|
|
Change in PROMIS Global Mental Health T-Score Between Baseline and 6-months
|
0.69 T-score
Standard Deviation 6.84
|
3.13 T-score
Standard Deviation 6.07
|
Adverse Events
Health Systems-level Intervention
CHW-led Patient Navigation Program
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place