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

Overview

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.

Full Title of Study: “Culturally Adapted Multilevel Decision Support Navigation Trial To Reduce Colorectal Cancer Disparity Among At-Risk Asian American Primary Care Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 31, 2022

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Advanced Control
    • The advanced control group receives a set of standard materials regarding colorectal cancer screening.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Knowledge about colorectal cancer and colorectal cancer screening (Baseline)
    • Time Frame: Baseline
    • Measure knowledge about colorectal cancer and colorectal cancer screening at baseline.
  • Knowledge about colorectal cancer and colorectal cancer screening (6 months)
    • Time Frame: 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
    • Time Frame: Baseline and 6 months
    • Measure change in knowledge score about colorectal cancer and colorectal cancer screening between baseline and 6 months.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Maryland, College Park
  • Collaborator
    • National Institute on Minority Health and Health Disparities (NIMHD)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Young S Oh, M.Ed, 240-705-1521, ohjoy@umd.edu

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