Korean CRC Screening Study PT13599

• Sponsor: Temple University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04478110
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 925
• Location: 1
• Arms: 2
• Actual Duration (Months): 56
• Patients Per Site Per Month: 16.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Behavioral: interactive group education, navigation services and engagement of health care providers for referrals, and linkage to care.; Behavioral: Education Session on General Health	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 925 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Screening
• Official Title: Community-Based Participatory Intervention to Improve Colorectal Cancer Screening Among Under-Served Korean Americans
• Actual Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. CRC screening rates [12 months]

   the completion of either FIT kit, sigmoidoscopy, or colonoscopy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Asian Health, Lewis Katz School of Medicine, Temple University	Philadelphia	Pennsylvania	United States	19140

Sponsors and Collaborators

• Temple University
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Grace X Ma, PhD, Temple University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

• 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.

• Responsible Party: Temple University
• ClinicalTrials.gov Identifier: NCT04478110
• Other Study ID Numbers: Korean CRC; U54CA153513
• First Posted: Jul 20, 2020
• Last Update Posted: Jul 27, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Jul 27, 2020