NCT03481296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

August 20, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

2.9 years

First QC Date

March 2, 2018

Last Update Submit

June 30, 2023

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer ScreeningAsian AmericansPatient NavigationDecision Counseling Program

Outcome Measures

Primary Outcomes (14)

  • 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 Outcomes (3)

  • Knowledge about colorectal cancer and colorectal cancer screening (Baseline)

    Baseline

  • Knowledge about colorectal cancer and colorectal cancer screening (6 months)

    6 months

  • Change in knowledge about colorectal cancer and colorectal cancer screening between baseline and 6 months

    Baseline and 6 months

Study Arms (2)

Advanced Control

ACTIVE COMPARATOR

The advanced control group receives a set of standard materials regarding colorectal cancer screening.

Behavioral: Advanced Control

Culturally Adapted Decision Support Navigation Intervention

EXPERIMENTAL

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

Interventions

Advanced ControlBEHAVIORAL

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.

Advanced Control
Culturally-Adapted Decision Support Navigation InterventionBEHAVIORAL

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.

Culturally Adapted Decision Support Navigation Intervention

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female Chinese and Korean American patients aged 50 to 75, who are not up to date for colorectal cancer screening

You may not qualify if:

  • Those with a family history, previous history of removing polyps, inflammatory bowel disease, or diagnosis of colorectal cancer screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

Related Publications (5)

  • Morey BN, Shi Y, Ryu S, Redline S, Kawachi I, Park HW, Lee S. Risk of sleep apnea associated with higher blood pressure among Chinese and Korean Americans. Ethn Health. 2024 Apr;29(3):295-308. doi: 10.1080/13557858.2024.2311417. Epub 2024 Feb 2.

    PMID: 38303653DERIVED

  • Morey BN, Ryu S, Shi Y, Lee S. The Mediating Role of Sleep Disturbance on the Association Between Stress and Self-Rated Health Among Chinese and Korean Immigrant Americans. Prev Chronic Dis. 2023 Jan 26;20:E04. doi: 10.5888/pcd20.220241.

    PMID: 36701271DERIVED

  • Lee S, Ryu S, Lee GE, Redline S, Morey BN. Risk of Sleep Apnea Is Associated with Abdominal Obesity Among Asian Americans: Comparing Waist-to-Hip Ratio and Body Mass Index. J Racial Ethn Health Disparities. 2024 Feb;11(1):157-167. doi: 10.1007/s40615-022-01507-z. Epub 2023 Jan 9.

    PMID: 36622567DERIVED

  • 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.

    PMID: 35705844DERIVED

  • 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.

    PMID: 34922392DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Sunmin Lee, ScD

    UC Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 2, 2018

First Posted

March 29, 2018

Study Start

August 20, 2018

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)