Clinical trial NCT03481296: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer Screening
Asian Americans
Patient Navigation
Decision Counseling Program
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Thomas Jefferson University
name: University of Maryland, College Park
First posted: 2018-03-29
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Colorectal cancer screening adherence at 6 months by medical record review
timeFrame: 6 months
measure: Colorectal cancer screening adherence at 6 months by self-report
timeFrame: 6 months
measure: Overall colorectal cancer screening adherence at 12 months by medical record review
timeFrame: 12 months
measure: Overall colorectal cancer screening adherence at 12 months by self-report
timeFrame: 12 months
measure: Colorectal cancer screening decision stage at baseline (Stool Blood Test)
timeFrame: Baseline
measure: Colorectal cancer screening decision stage at 6-months (Stool Blood Test)
timeFrame: 6 months
measure: Change in colorectal cancer screening decision stage between baseline and 6 months (Stool Blood Test)
timeFrame: Baseline and 6 months
measure: Colorectal cancer screening decision stage at baseline (Colonoscopy)
timeFrame: Baseline
measure: Colorectal cancer screening decision stage at 6 months (Colonoscopy)
timeFrame: 6 months
measure: Change in colorectal cancer screening decision stage between baseline and 6 months (Colonoscopy)
timeFrame: Baseline and 6 months
measure: Colorectal cancer screening test-specific adherence at 6 months (Stool Blood Test)
timeFrame: 6 months
measure: Colorectal cancer screening test-specific adherence at 6 months (Colonoscopy)
timeFrame: 6 months
measure: Colorectal cancer screening test-specific adherence at 12 months (Stool Blood Test)
timeFrame: 12 months
measure: Colorectal cancer screening test-specific adherence at 12 months (Colonoscopy)
timeFrame: 12 months
Secondary outcomes:
measure: Knowledge about colorectal cancer and colorectal cancer screening (Baseline)
timeFrame: Baseline
measure: Knowledge about colorectal cancer and colorectal cancer screening (6 months)
timeFrame: 6 months
measure: Change in knowledge about colorectal cancer and colorectal cancer screening between baseline and 6 months
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: UC Irvine
name: Sunmin Lee, ScD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.