NCT04478110

Brief Summary

Korean Americans report the lowest and declined rates of colorectal cancer (CRC) screening, compared to general population in the United States. The present study aimed to evaluate the efficacy of a community-based multifaceted intervention designed to improve CRC screening among Korean Americans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
925

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Dec 2010

Longer than P75 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

Study Start

First participant enrolled

December 1, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

4.7 years

First QC Date

July 15, 2020

Last Update Submit

April 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • CRC screening rates

    the completion of either FIT kit, sigmoidoscopy, or colonoscopy

    12 months

Study Arms (2)

Interactive education with linkage to care

EXPERIMENTAL

Main intervention components included interactive group education, navigation services and engagement of health care providers for referrals, and linkage to care

Behavioral: interactive group education, navigation services and engagement of health care providers for referrals, and linkage to care.

general health education

ACTIVE COMPARATOR

Receive a group education session focused on general health education and primary prevention issues.

Behavioral: Education Session on General Health

Interventions

The interactive group education was aimed to increase participant overall understanding of CRC, screening methods, and utilization of available resources such as home test kit and navigation services, with the ultimate goal of increasing screening rates. Clinical partners provided clinical support and ensured successful screening assessment and follow-ups by offering more flexible hours of clinic operation with bilingual medical staff on site. Patient navigation assistance was also offered based on participants' needs. The range of assistance included scheduling appointments with clinical partners for sigmoidoscopy/colonoscopy for screening and diagnosis after a FIT positive result, assisting paper.

Interactive education with linkage to care

Participants in the control group received a group education session in a similar format with that of the intervention group delivered by trained Korean community health educators. Different from the intervention group, the education focused on general health education and primary prevention issues, including routine health examinations and screening for various diseases such as cancer. Korean version of work and communication with a physician, and arranging transportation. standard printed materials and guidelines related to the education contents were also provided, including CRC screening guidelines.

general health education

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants were eligible to participate in this study if they:
  • were self-identified Korean Americans;
  • were 50 years and older;
  • did not have a colorectal polyp, CRC cancer, or a family history of CRC (first degree relative); and
  • non-adherent to CRC screening guidelines (never had any CRC screening or were overdue for screening).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Asian Health, Lewis Katz School of Medicine, Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (1)

  • Ma GX, Lee M, Beeber M, Das R, Feng Z, Wang MQ, Tan Y, Zhu L, Navder K, Shireman TI, Siu P, Rhee J, Nguyen MT. Community-Clinical Linkage Intervention to Improve Colorectal Cancer Screening Among Underserved Korean Americans. Cancer Health Disparities. 2019;3:e1-e15. Epub 2019 Aug 19.

    PMID: 31528846BACKGROUND

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Grace X Ma, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 20, 2020

Study Start

December 1, 2010

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations