Screening TO Prevent ColoRectal Cancer (STOP CRC) Among At-Risk Chinese and Korean American Primary Care Patients

Culturally Adapted Multilevel Decision Support Navigation Trial To Reduce Colorectal Cancer Disparity Among At-Risk Asian American Primary Care Patients

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Advanced Control; Behavioral: Culturally-Adapted Decision Support Navigation Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • University of California, Irvine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Advanced Control; The advanced control group receives a set of standard materials regarding colorectal cancer screening.	Behavioral: Advanced Control; 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.
Experimental: Culturally Adapted Decision Support Navigation Intervention; The culturally adapted decision support navigation intervention group receives everything advanced group receives as well as decision support and navigation contacts.	Behavioral: Culturally-Adapted Decision Support Navigation Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colorectal cancer screening adherence at 6 months by medical record review	Measure overall colorectal cancer screening adherence at 6 months by medical record review.	6 months
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).	6 months
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.	12 months
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).	12 months
Colorectal cancer screening decision stage at baseline (Stool Blood Test)	Measure colorectal cancer screening decision stage for stool blood test at baseline.	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.	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.	Baseline and 6 months
Colorectal cancer screening decision stage at baseline (Colonoscopy)	Measure colorectal cancer screening decision stage for colonoscopy at baseline.	Baseline
Colorectal cancer screening decision stage at 6 months (Colonoscopy)	Measure colorectal cancer screening decision stage for colonoscopy at 6 months.	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.	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.	6 months
Colorectal cancer screening test-specific adherence at 6 months (Colonoscopy)	Measure the fraction of participants who undergo a colonoscopy at 6 months.	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.	12 months
Colorectal cancer screening test-specific adherence at 12 months (Colonoscopy)	Measure the fraction of participants who undergo a colonoscopy at 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge about colorectal cancer and colorectal cancer screening (Baseline)	Measure knowledge about colorectal cancer and colorectal cancer screening at baseline.	Baseline
Knowledge about colorectal cancer and colorectal cancer screening (6 months)	Measure knowledge about colorectal cancer and colorectal cancer screening at 6 months.	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.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Thomas Jefferson University; University of Maryland, College Park
• Investigators: Principal Investigator: Sunmin Lee, ScD, UC Irvine

Publications and helpful links

General Publications

• Morey BN, Ryu S, Shi Y, Park HW, Lee S. Acculturation and Cardiometabolic Abnormalities Among Chinese and Korean Americans. J Racial Ethn Health Disparities. 2022 Jun 15:1-11. doi: 10.1007/s40615-022-01347-x. Online ahead of print.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Patient Navigation; Colorectal Cancer Screening; Asian Americans; Decision Counseling Program
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: R01MD012778 [2020-5953]; 1R01MD012778-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No