Back to resultsKorean CRC Screening Study PT13599
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
interactive group education, navigation services and engagement of health care providers for referrals, and linkage to care.
Education Session on General Health
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer
Eligibility Criteria
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:
Sites / Locations
- Center for Asian Health, Lewis Katz School of Medicine, Temple University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interactive education with linkage to care
general health education
Arm Description
Main intervention components included interactive group education, navigation services and engagement of health care providers for referrals, and linkage to care
Receive a group education session focused on general health education and primary prevention issues.
Outcomes
Primary Outcome Measures
CRC screening rates
the completion of either FIT kit, sigmoidoscopy, or colonoscopy
Secondary Outcome Measures
Full Information
NCT ID
NCT04478110
First Posted
July 15, 2020
Last Updated
April 11, 2023
Sponsor
Temple University
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04478110
Brief Title
Korean CRC Screening Study PT13599
Official Title
Community-Based Participatory Intervention to Improve Colorectal Cancer Screening Among Under-Served Korean Americans
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 2010 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
925 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interactive education with linkage to care
Arm Type
Experimental
Arm Description
Main intervention components included interactive group education, navigation services and engagement of health care providers for referrals, and linkage to care
Arm Title
general health education
Arm Type
Active Comparator
Arm Description
Receive a group education session focused on general health education and primary prevention issues.
Intervention Type
Behavioral
Intervention Name(s)
interactive group education, navigation services and engagement of health care providers for referrals, and linkage to care.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education Session on General Health
Intervention Description
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.
Primary Outcome Measure Information:
Title
CRC screening rates
Description
the completion of either FIT kit, sigmoidoscopy, or colonoscopy
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace X Ma, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Asian Health, Lewis Katz School of Medicine, Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31528846
Citation
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.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6746426/
Description
Related Info
Learn more about this trial
Korean CRC Screening Study PT13599
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