- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03413605
U01 CRC Project for Vietnamese Americans
July 20, 2023 updated by: Temple University
A Multilevel CBPR Intervention to Improve Colorectal Cancer Screening in Underserved Vietnamese Americans
Colorectal cancer (CRC) is the second most commonly diagnosed cancer and the third highest cause of mortality in Vietnamese and Asian Americans.
CRC incidence is rising rapidly in Vietnamese Americans, but they have among the lowest rates of CRC screening (14%) and are more likely to be diagnosed with advanced stage disease, which is highly preventable.
Over 85% of Vietnamese Americans in our region (PA, NJ and NYC) are foreign-born with limited English proficiency, have low SES, and live in economically disadvantaged neighborhoods.
Many lack knowledge about CRC risks and screening benefits and have limited access to culturally appropriate preventive care.
Center for Asian Health, Temple University will be working with Vietnamese CBOs to address their critical health disparities.
The investigators will test the hypothesis that the proposed multilevel CRC intervention will yield higher CRC screening rates compared to the control at 12-month follow-up.
This project represents the first large-scale community-based randomized controlled trial of a multilevel, culturally-appropriate intervention to increase CRC screening among underserved Vietnamese.
If effective, this innovative CRC intervention can be used as a model program that has potential impact, generalizability and sustainability in Asian American and other underserved ethnic communities.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Colorectal cancer (CRC) is the second most commonly diagnosed cancer and the third highest cause of mortality in Vietnamese and Asian Americans.
CRC incidence is rising rapidly in Vietnamese Americans, but they have among the lowest rates of CRC screening (14%) and are more likely to be diagnosed with advanced stage disease, which is highly preventable.
Over 85% of Vietnamese Americans in our region (PA, NJ, and NYC) are foreign-born with limited English proficiency, have low SES, and live in economically disadvantaged neighborhoods.
Many lack knowledge about CRC risks and screening benefits and have limited access to culturally appropriate preventive care.
Thus, a multilevel intervention is needed to address the multiple barriers to and determinants of CRC screening in this community.
Vietnamese community organizations (VCOs) serve dynamic social functions and represent an important resource for addressing this critical health disparity priority by promoting CRC screening.
This project builds on established partnerships and successful work of Center for Asian Health, Temple University with Vietnamese CBOs that address their overwhelming health disparities.
CBPR principles will be applied to engage 20 VCOs in all phases of planning, implementing, evaluating, and disseminating a culturally appropriate, theory- and evidence-based multilevel CRC intervention.
The proposed intervention will be guided by Social Ecological Model, which addresses sociocultural, behavioral and environmental determinants and intervention strategies at the individual, interpersonal, and community organizational levels.
CDC's Clinical Preventive Services Guidelines for adults 50+ (CPS) recommend that cancer screenings and other preventive services should be promoted.
The standard CPS will be provided to both intervention and control groups, and intervention group will receive CPS + multilevel CRC intervention.
Specific Aim 1 is to test the hypothesis that CPS + multilevel CRC intervention will yield higher CRC screening rates compared to CPS control at 12-month follow up; Aim 2 is to examine whether CPS + multilevel CRC intervention (which includes CHW-led group education, automated and interactive text messaging and phone-based peer support) is more effective in changing screening determinants (e.g.
KAB, self-efficacy, risk factors, lifestyles, social support, social norms, access barriers) than CPS control condition; and Aim 3 is to assess costs and cost-effectiveness of CPS + multilevel CRC intervention compared to CPS control condition in relation to CRC screening rates in order to inform future dissemination efforts.
In sum, this project represents the first large-scale community-based randomized controlled trial of a multilevel, culturally-appropriate CBPR intervention to increase CRC screening among underserved Vietnamese.
If effective, this innovative multilevel CRC intervention can be used as a model program that has potential generalizability and sustainability in Asian American and other underserved ethnic communities to impact preventive behaviors at the population level.
Study Type
Interventional
Enrollment (Actual)
801
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
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New Jersey
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Atlantic City, New Jersey, United States, 08401
- Vietnamese community center of Atlantic city
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19147
- Bo De Temple
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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:
- self-identified Vietnamese ethnicity,
- age 50 and above,
- accessible by cell telephone,
- presence in the same geographic study area for a period of one year (to minimize participant attrition);
- not enrolled in any CRC intervention (to prevent a potential program impact),
- do not have the colorectal polyp, CRC cancer or a family history of CRC (first-degree relative),
- non-adherent to CRC screening guidelines (never had CRC screening or are overdue for screening).
Exclusion Criteria:
- enrolled in any CRC intervention (to prevent a potential program impact)
- have the colorectal polyp, CRC cancer or a family history of CRC
- had CRC screening or adherent to CRC screening guidelines
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: a multilevel CBPR intervention
The intervention will be delivered in group-based education workshop format.
The education session is a curriculum-based group education; each group will be having about 15-20 participants.
We will allow 5-7 minutes for participants to get to know each other and to get comfortable talking to the group.
Education will have two major topics.(a)
CDC's standard Clinical Preventive Services Guidelines for adults 50+ (CPS).
(b) culturally tailored CRC information discussion.
This session is to increase knowledge, change cultural beliefs and attitudes on risks of CRC and benefits of screening by using interactive discussion approaches, visual aids, motivation video and print materials.
|
The intervention will be implemented through a group-based education workshop.
The education session is a curriculum-based group education; each group will be having about 15-20 participants.
All group education sessions will take place at collaborating Viet community partners sites, and delivered in Vietnamese language, with offering of refreshment.
We will allow 5-7 minutes for participants to get to know each other and to get comfortable talking to the group.
Education will have two major topics--- (a) CDC's standard Clinical Preventive Services Guidelines for adults 50+ (CPS).
(b) culturally tailored CRC information discussion.
|
No Intervention: control group
the standard CDC's Clinical Preventive Services Guidelines for adults 50+ (CPS) will be provided to control groups.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Colorectal Cancer Screening Rate
Time Frame: 12 months
|
percentage of subjects, who received colorectal screening at 12-month Follow Up
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Grace X Ma, PhD, Temple University
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)
June 1, 2016
Primary Completion (Actual)
April 28, 2021
Study Completion (Actual)
April 28, 2021
Study Registration Dates
First Submitted
December 11, 2017
First Submitted That Met QC Criteria
January 22, 2018
First Posted (Actual)
January 29, 2018
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
July 20, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U01 Viet CRC
- U01MD010627 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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