Korean CRC Screening Study PT13599

April 11, 2023 updated by: Temple University

Community-Based Participatory Intervention to Improve Colorectal Cancer Screening Among Under-Served Korean Americans

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

925

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Center for Asian Health, Lewis Katz School of Medicine, Temple University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants were eligible to participate in this study if they:

    1. were self-identified Korean Americans;
    2. were 50 years and older;
    3. did not have a colorectal polyp, CRC cancer, or a family history of CRC (first degree relative); and

    4. non-adherent to CRC screening guidelines (never had any CRC screening or were overdue for screening).

      Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interactive education with linkage to care
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.
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.
Active Comparator: general health education
Receive a group education session focused on general health education and primary prevention issues.
Behavioral: Education Session on General Health
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRC screening rates
Time Frame: 12 months
the completion of either FIT kit, sigmoidoscopy, or colonoscopy
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2010

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Korean CRC
  • U54CA153513 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe