- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04478110
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
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
-
-
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:
- 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).
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
|
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.
|
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
Collaborators
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.
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.
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