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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03481296
• Other study ID #: R01MD012778 [2020-5953]
• Secondary ID: 1R01MD012778-01A
• Status: Completed
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2023
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Irvine	National Institute on Minority Health and Health Disparities (NIMHD), Thomas Jefferson University, University of Maryland, College Park

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Colorectal cancer screening decision stage at baseline (Stool Blood Test)	Measure colorectal cancer screening decision stage for stool blood test at baseline.	Baseline
Primary	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
Primary	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
Primary	Colorectal cancer screening decision stage at baseline (Colonoscopy)	Measure colorectal cancer screening decision stage for colonoscopy at baseline.	Baseline
Primary	Colorectal cancer screening decision stage at 6 months (Colonoscopy)	Measure colorectal cancer screening decision stage for colonoscopy at 6 months.	6 months
Primary	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
Primary	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
Primary	Colorectal cancer screening test-specific adherence at 6 months (Colonoscopy)	Measure the fraction of participants who undergo a colonoscopy at 6 months.	6 months
Primary	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
Primary	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	Knowledge about colorectal cancer and colorectal cancer screening (Baseline)	Measure knowledge about colorectal cancer and colorectal cancer screening at baseline.	Baseline
Secondary	Knowledge about colorectal cancer and colorectal cancer screening (6 months)	Measure knowledge about colorectal cancer and colorectal cancer screening at 6 months.	6 months
Secondary	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