A Multilevel CBPR Intervention to Improve Colorectal Cancer Screening in Underserved Vietnamese Americans
Phase: NA
Conditions: Colorectal Cancer
Sponsor: Temple University

Protocol Template for Minimal Risk Studies not Regulated by FDA 
 
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Official title of the study 
 
 
A Multilevel CBPR Intervention to Improve 
Colorectal Cancer Screening in Underserved 
Vietnamese Americans 
 
 
 
NCT number: NCT03413605 
 
 
 
Date of the study protocol with SAP: May 8, 2020 
 
 
 

Protocol Template for Minimal Risk Studies not Regulated by FDA 
 
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  Revision: May 08, 2020 
 
1)  Abstract of the study 
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. Specific Aim is to 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 generalizability and 
sustainability in Asian American and other underserved ethnic communities to impact 
preventive behaviors at population level.  
 
2) Objectives 
The overall goal is to use a CBPR approach to collaborate with Vietnamese CBO partners 
to increase CRC screening by reducing multilevel healthcare access barriers for 
underserved Vietnamese Americans. 
 
The purpose of the study is to determine the effectiveness of a multilevel, theory- 
and evidence-based CBPR intervention to increase CRC screening in 
underserved Vietnamese. The proposed multilevel CRC intervention will be guided 
by Social Ecological Model that addresses sociocultural, behavioral and 
environmental 
determinants 
and 
intervention 
strategies 
at 
individual, 
interpersonal, and community organizational levels for obtaining CRC screening. 
Specific Aims: 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.  
It is hypothesized that the multilevel CRC intervention will yield higher CRC 
screening rates compared to CPS control at 12-month follow up. 
 
3) Resources and Setting  

Protocol Template for Minimal Risk Studies not Regulated by FDA 
 
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All key personal involved in this study were trained for this protocol, have meetings 
regarding the materials development, timeline and process of this study to ensure that all 
key personals were on the same page along with the study progress. The study PI and 
senior key staff members will provide detailed training about the study to all personal 
involved in this study including project coordinator, community health workers, 
collaborating community leaders and designated staff from collaborating partners.  
 
The study will be conducted in greater Philadelphia area including (south NJ, DE and PA 
areas) and New York City with our long collaborating community partners. All participants 
in the described study will be identified and recruited by collaborating community partners, 
and consented by trained team staff of Center for Asian Health, Temple University.  
 
4) Study Design 
a) Recruitment Methods 
In total, 900 participants will be recruited, including:  
• 800 study participants 
• 40 CBO leaders/staff from 20 collaborating CBO partners 
• 60 family members or close friends of study participants.  
 
The research team will recruit subjects after the TU IRB office approves the protocol. 
 
 
Participants will be recruited through collaboration with Vietnamese community-based 
organization partners located in greater Philadelphia area including (south NJ, DE and PA 
areas) and New York City. Over the past 16 years, the Center for Asian Health has 
established solid collaboration relationships with these partners. In this study’s recruitment 
effort, the Center has received collaboration commitment from the community leaders 
during grant proposal development stage. Planning meeting will be conducted with 
collaborating community leaders.   
 
A total of $45 incentive for completing all survey forms before and after 
workshop and the telephone interview (or in-person survey form 
collection) at 12-month after the workshop (additional $20 incentive will be 
provided for completing the expanded 12-month follow up survey form).   
 
b) Inclusion and Exclusion Criteria 
 
Inclusion Criteria:  
• 
Study participants (N=800) will be included in the study if they meet the following 
criteria:  
1) self-identified Vietnamese ethnicity, 2) age 50 and above, 3) accessible by cell 
telephone, 4) presence in the same geographic study area for a period of one year 

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(to minimize participant attrition); 5) not enrolled in any CRC intervention (to 
prevent a potential program impact), 6) do not have colorectal polyp, CRC cancer 
or a family history of CRC (first degree relative). The guidelines recommended by 
American Cancer Society will be used to determine participants’ screening 
eligibility: No FIT in past year or no sigmoidoscopy in past 5 years, no double-
contrast barium enema in the past 5 years, or no colonoscopy within the past 10 
years 
• 
CBO leaders/staff (n=40) will be included in the study if they meet the 
following criteria: 1) Self-identified Vietnamese ethnicity, 2) CBO leader 
involved in the study, 3) Accessible by telephone or cell telephone.  
• 
Family members or close friends of study participants (n=60) will be included in 
the study if they self-identified as a family member or a close friend of the study 
participant, who provided help to study participant during his/her health care 
activities. 
 
c) Study Procedures, Method, and Data Analysis Plan 
 
Research design/method- This is a 2-arm randomized controlled trial with baseline, post-
education test and 12-month assessments.  Collaborating Viet community partners will be 
randomly assigned into either intervention group, or comparison group; participants 
enrolled from each participating community partner will be automatically assigned to their 
CBO study group: intervention or comparison.  
 
Group education workshops will be arranged in working collaborating community partners. 
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.  
 
In addition to information collection from study participants, we will conduct 
telephone interview with 40 leaders/staff from 20 collaborating CBO partners (2 
persons per partner site) to gain feedback about the intervention when field 
research activities is completed.  
 
Feedback about the intervention will also be gathered from 60 family members 
(or close friends) of 60 study participants. 
For data analysis approach, first, we will perform analysis using Viet community 
organization as unit of analysis. For testing main null hypothesis of no difference 
in primary endpoint (conversion to screening compliant) and secondary endpoints, 
we will use randomization tests with a randomization distribution in accord with 
stratified randomization of the experimental design.  Second, we will also perform 
statistical analyses using individual as unit of analysis. For these analyses, we will 
use the generalized linear mixed models for the regression analysis of correlated 
binary response data with covariates specific to the individual.