Screening TO Prevent ColoRectal Cancer (STOP CRC) Among At-Risk Chinese and Korean American Primary Care Patients
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Advanced Control
Culturally-Adapted Decision Support Navigation Intervention
Sponsored by

About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring Colorectal Cancer Screening, Asian Americans, Patient Navigation, Decision Counseling Program
Eligibility Criteria
Inclusion Criteria:
- Male and female Chinese and Korean American patients aged 50 to 75, who are not up to date for colorectal cancer screening
Exclusion Criteria:
- Those with a family history, previous history of removing polyps, inflammatory bowel disease, or diagnosis of colorectal cancer screening.
Sites / Locations
- University of California, Irvine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Advanced Control
Culturally Adapted Decision Support Navigation Intervention
Arm Description
The advanced control group receives a set of standard materials regarding colorectal cancer screening.
The culturally adapted decision support navigation intervention group receives everything advanced group receives as well as decision support and navigation contacts.
Outcomes
Primary Outcome Measures
Colorectal cancer screening adherence at 6 months by medical record review
Measure overall colorectal cancer screening adherence at 6 months by medical record review.
Colorectal cancer screening adherence at 6 months by self-report
Measure overall colorectal cancer screening adherence at 6 months by self-report during 6-month survey (by phone).
Overall colorectal cancer screening adherence at 12 months by medical record review
Measure overall colorectal cancer screening adherence at 12 months by medical record review.
Overall colorectal cancer screening adherence at 12 months by self-report
Measure overall colorectal cancer screening adherence at 12 months by self-report (by phone interview).
Colorectal cancer screening decision stage at baseline (Stool Blood Test)
Measure colorectal cancer screening decision stage for stool blood test at baseline.
Colorectal cancer screening decision stage at 6-months (Stool Blood Test)
Measure colorectal cancer screening decision stage for stool blood test at 6 months.
Change in colorectal cancer screening decision stage between baseline and 6 months (Stool Blood Test)
Measure change in colorectal cancer screening decision stage for stool blood test between baseline and 6 months.
Colorectal cancer screening decision stage at baseline (Colonoscopy)
Measure colorectal cancer screening decision stage for colonoscopy at baseline.
Colorectal cancer screening decision stage at 6 months (Colonoscopy)
Measure colorectal cancer screening decision stage for colonoscopy at 6 months.
Change in colorectal cancer screening decision stage between baseline and 6 months (Colonoscopy)
Measure change in colorectal cancer screening decision stage for colonoscopy between baseline and 6 months.
Colorectal cancer screening test-specific adherence at 6 months (Stool Blood Test)
Measure the fraction of participants who undergo a stool blood test at 6 months.
Colorectal cancer screening test-specific adherence at 6 months (Colonoscopy)
Measure the fraction of participants who undergo a colonoscopy at 6 months.
Colorectal cancer screening test-specific adherence at 12 months (Stool Blood Test)
Measure the fraction of participants who undergo a stool blood test at 12 months.
Colorectal cancer screening test-specific adherence at 12 months (Colonoscopy)
Measure the fraction of participants who undergo a colonoscopy at 12 months.
Secondary Outcome Measures
Knowledge about colorectal cancer and colorectal cancer screening (Baseline)
Measure knowledge about colorectal cancer and colorectal cancer screening at baseline.
Knowledge about colorectal cancer and colorectal cancer screening (6 months)
Measure knowledge about colorectal cancer and colorectal cancer screening at 6 months.
Change in knowledge about colorectal cancer and colorectal cancer screening between baseline and 6 months
Measure change in knowledge score about colorectal cancer and colorectal cancer screening between baseline and 6 months.
Full Information
NCT ID
NCT03481296
First Posted
March 2, 2018
Last Updated
June 30, 2023
Sponsor
University of California, Irvine
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), Thomas Jefferson University, University of Maryland, College Park
1. Study Identification
Unique Protocol Identification Number
NCT03481296
Brief Title
Screening TO Prevent ColoRectal Cancer (STOP CRC) Among At-Risk Chinese and Korean American Primary Care Patients
Official Title
Culturally Adapted Multilevel Decision Support Navigation Trial To Reduce Colorectal Cancer Disparity Among At-Risk Asian American Primary Care Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), Thomas Jefferson University, University of Maryland, College Park
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The objective of the study is to conduct a randomized controlled trial to determine the impact of a multi-level culturally-sensitive decision support intervention on colorectal cancer screening adherence among 400 Chinese and Korean American primary care patients.
Detailed Description
This study culturally adapts existing evidence-based decision support navigation intervention and tests its efficacy among 200 Chinese and Korean American men and 200 Chinese and Korean American women aged 50 to 75 eligible for colorectal cancer screening. Participants are recruited from primary care physician clinics. The study is designed to compare colorectal cancer screening outcomes between the decision support navigation intervention and the advanced control. Those randomized to the advanced control group only receives an informational booklet, a stool blood test kit and a reminder by mail. Those randomized to the decision support navigation intervention group receives everything the advanced control group receives as well as decision support and navigation contacts. Investigators in the study develop an individualized screening plan using a theory-based online Decision Counseling Program, share the plan with the participants' primary care physicians, and have primary care physicians to encourage the colorectal cancer screening to participants. Using outcomes data collected by survey and medical record review, this study: (1) determines overall colorectal cancer screening adherence in the culturally adapted decision support navigation intervention vs. the advanced control; (2) measures change in colorectal cancer screening decision stage in the culturally adapted decision support navigation intervention vs. the advanced control; and (3) assesses colorectal cancer screening test-specific (stool blood test vs. colonoscopy) adherence in the culturally adapted decision support navigation intervention vs. the advanced control. Additionally, investigators in the study evaluate intervention reach, effectiveness, adoption, implementation, and maintenance using interview data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer Screening, Asian Americans, Patient Navigation, Decision Counseling Program
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Advanced Control
Arm Type
Active Comparator
Arm Description
The advanced control group receives a set of standard materials regarding colorectal cancer screening.
Arm Title
Culturally Adapted Decision Support Navigation Intervention
Arm Type
Experimental
Arm Description
The culturally adapted decision support navigation intervention group receives everything advanced group receives as well as decision support and navigation contacts.
Intervention Type
Behavioral
Intervention Name(s)
Advanced Control
Intervention Description
Participants receive linguistically and culturally tailored information booklet on colorectal cancer and colorectal cancer screening, colonoscopy instructions, stool blood test kits and reminder by mail. Participants' height, weight, and waist/hip circumference, blood pressure, blood glucose, and cholesterol levels will be measured by trained research staff. Participants will also receive the result of body measurements right away as a free service.
Intervention Type
Behavioral
Intervention Name(s)
Culturally-Adapted Decision Support Navigation Intervention
Intervention Description
Participants in this group receive everything that advanced control group receives. In addition to a set of standard materials, they receive culturally and linguistically adapted decision counseling from the patient navigator. The patient navigator develops an individualized colorectal cancer screening plan using a theory-based online Decision Counseling Program. After the Program is completed, the patient navigator develops individualized colorectal cancer screening plan and shares the information with participants and participants' primary care physicians. Then, primary care physicians encourage the colorectal cancer screening to participants.
Primary Outcome Measure Information:
Title
Colorectal cancer screening adherence at 6 months by medical record review
Description
Measure overall colorectal cancer screening adherence at 6 months by medical record review.
Time Frame
6 months
Title
Colorectal cancer screening adherence at 6 months by self-report
Description
Measure overall colorectal cancer screening adherence at 6 months by self-report during 6-month survey (by phone).
Time Frame
6 months
Title
Overall colorectal cancer screening adherence at 12 months by medical record review
Description
Measure overall colorectal cancer screening adherence at 12 months by medical record review.
Time Frame
12 months
Title
Overall colorectal cancer screening adherence at 12 months by self-report
Description
Measure overall colorectal cancer screening adherence at 12 months by self-report (by phone interview).
Time Frame
12 months
Title
Colorectal cancer screening decision stage at baseline (Stool Blood Test)
Description
Measure colorectal cancer screening decision stage for stool blood test at baseline.
Time Frame
Baseline
Title
Colorectal cancer screening decision stage at 6-months (Stool Blood Test)
Description
Measure colorectal cancer screening decision stage for stool blood test at 6 months.
Time Frame
6 months
Title
Change in colorectal cancer screening decision stage between baseline and 6 months (Stool Blood Test)
Description
Measure change in colorectal cancer screening decision stage for stool blood test between baseline and 6 months.
Time Frame
Baseline and 6 months
Title
Colorectal cancer screening decision stage at baseline (Colonoscopy)
Description
Measure colorectal cancer screening decision stage for colonoscopy at baseline.
Time Frame
Baseline
Title
Colorectal cancer screening decision stage at 6 months (Colonoscopy)
Description
Measure colorectal cancer screening decision stage for colonoscopy at 6 months.
Time Frame
6 months
Title
Change in colorectal cancer screening decision stage between baseline and 6 months (Colonoscopy)
Description
Measure change in colorectal cancer screening decision stage for colonoscopy between baseline and 6 months.
Time Frame
Baseline and 6 months
Title
Colorectal cancer screening test-specific adherence at 6 months (Stool Blood Test)
Description
Measure the fraction of participants who undergo a stool blood test at 6 months.
Time Frame
6 months
Title
Colorectal cancer screening test-specific adherence at 6 months (Colonoscopy)
Description
Measure the fraction of participants who undergo a colonoscopy at 6 months.
Time Frame
6 months
Title
Colorectal cancer screening test-specific adherence at 12 months (Stool Blood Test)
Description
Measure the fraction of participants who undergo a stool blood test at 12 months.
Time Frame
12 months
Title
Colorectal cancer screening test-specific adherence at 12 months (Colonoscopy)
Description
Measure the fraction of participants who undergo a colonoscopy at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Knowledge about colorectal cancer and colorectal cancer screening (Baseline)
Description
Measure knowledge about colorectal cancer and colorectal cancer screening at baseline.
Time Frame
Baseline
Title
Knowledge about colorectal cancer and colorectal cancer screening (6 months)
Description
Measure knowledge about colorectal cancer and colorectal cancer screening at 6 months.
Time Frame
6 months
Title
Change in knowledge about colorectal cancer and colorectal cancer screening between baseline and 6 months
Description
Measure change in knowledge score about colorectal cancer and colorectal cancer screening between baseline and 6 months.
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female Chinese and Korean American patients aged 50 to 75, who are not up to date for colorectal cancer screening
Exclusion Criteria:
Those with a family history, previous history of removing polyps, inflammatory bowel disease, or diagnosis of colorectal cancer screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunmin Lee, ScD
Organizational Affiliation
UC Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35705844
Citation
Morey BN, Ryu S, Shi Y, Park HW, Lee S. Acculturation and Cardiometabolic Abnormalities Among Chinese and Korean Americans. J Racial Ethn Health Disparities. 2023 Aug;10(4):1605-1615. doi: 10.1007/s40615-022-01347-x. Epub 2022 Jun 15.
Results Reference
derived
PubMed Identifier
34922392
Citation
Lee S, Ryu S, Lee GE, Kawachi I, Morey BN, Slopen N. The association of acculturative stress with self-reported sleep disturbance and sleep duration among Asian Americans. Sleep. 2022 Apr 11;45(4):zsab298. doi: 10.1093/sleep/zsab298.
Results Reference
derived
Learn more about this trial
Screening TO Prevent ColoRectal Cancer (STOP CRC) Among At-Risk Chinese and Korean American Primary Care Patients
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