Culturally Adapted Multilevel Decision Support Navigation Trial To Reduce Colorectal Cancer Disparity Among At-Risk Asian American Primary Care Patients
Phase: NA
Conditions: Colorectal Cancer
Sponsor: University of California, Irvine

 
 
 
 
 
STOP CRC Program (NIH R01) Protocol 
 
 
Official Trial Title: Culturally Adapted Multilevel Decision Support Navigation Trial To 
Reduce Colorectal Cancer Disparity Among At-Risk Asian 
American Primary Care Patients 
Unique Protocol ID: R01MD012778 
Lead Organization: 
Document Date: 
University of Maryland 
   9/25/2018 
Participating Site Information: University of Maryland School of Public Health 
 
NCT Number: NCT03481296 
 
 
 
 
 
 
CONTACT INFORMATION: 
 
Sunmin Lee, ScD, Principal Investigator 
2234C School of Public Health Building 
Department of Epidemiology and Biostatistics 
University of Maryland School of Public Health 
College Park, MD 20742-2611 
Telephone: 301-405-7251 
sunmin@umd.edu 
 
Yan Qiao, Central Contact 
2366 School of Public Health Building 
Department of Epidemiology and Biostatistics 
University of Maryland School of Public Health 
College Park, Maryland 20742-2611 
Telephone: 240-484-3945 
yqiao805@umd.edu 

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Contents 
Introduction .................................................................................................................................................. 3 
Public Health Relevance ............................................................................................................................ 3 
Study Aim ...................................................................................................................................................... 4 
Study Design ................................................................................................................................................. 4 
Study Population ........................................................................................................................................... 4 
Enrollment ................................................................................................................................................ 4 
Inclusion Criteria ....................................................................................................................................... 4 
Exclusion Criteria ....................................................................................................................................... 4 
Procedures .................................................................................................................................................... 5 
Outcomes ...................................................................................................................................................... 5 
Primary Outcome Measure ....................................................................................................................... 6 
Ethical Considerations ................................................................................................................................... 7 
Potential Risks and Discomforts ................................................................................................................ 7 
Benefits ..................................................................................................................................................... 7 
Confidentiality ........................................................................................................................................... 7 

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Introduction 
Cancer is the leading cause of death among Asian Americans, and mortality from colorectal cancer is 
ranked as the second most common in cancer deaths among Asian Americans. However, recent data 
show that colorectal cancer screening rates are substantially lower for Chinese and Korean Americans 
compared with other racial/ethnic groups. To date, a small number of community-based studies have 
reported on the use of single level (participant level only) interventions to increase colorectal cancer 
screening rates among Chinese and Korean Americans; however, very little is known about the impact of 
multi-level (patient-oriented and provider-oriented) interventions on colorectal cancer screening 
adherence among Chinese and Korean American patients in primary care setting. Furthermore, our 
preliminary data indicate physician's recommendation as the strongest facilitator of colorectal cancer 
screening among Chinese and Korean Americans. Thus, the primary objective of the study is to address 
this important knowledge gap by conducting a randomized controlled trial to determine the impact of a 
multi-level culturally-sensitive decision support intervention on colorectal cancer screening adherence 
among 400 Chinese and Korean American primary care patients. Previous studies found that facilitating 
patient decision-making through decision support and providing patient navigation can increase 
colorectal cancer screening among diverse primary care patients. 
 
 
Public Health Relevance 
Cancer is the leading cause of death among Asian Americans, but colorectal cancer screening rate 
remains low in this population. The goal of this study is to increase colorectal cancer screening among 
underserved Chinese and Korean Americans through cultural adaptation and implementation of a 
decision support navigation trial provided in primary care setting. With growing need for linguistically 
and culturally competent care, more decision support, language facilitation, and navigation efforts may 
come into care settings; therefore, having tested interventions ready for the target population will be 
timely, and medical systems may benefit from having multilevel best practices known and tested for 
Chinese and Korean Americans. 

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Study Aim 
The aim of the study is to determine the impact of a multi-level culturally-sensitive intervention on 
colorectal cancer screening adherence among 400 Chinese and Korean American primary care patients. 
The specific aims are to: 
(1) Implement a randomized controlled trial among 400 Chinese and Korean American primary care 
patients to compare colorectal cancer screening outcomes between the culturally-adjusted decision 
support navigation intervention and advanced control; 
(2) Determine overall colorectal cancer screening adherence and change in colorectal cancer screening 
decision stage in the culturally adapted decision support navigation intervention versus advanced 
control; and 
(3) Evaluate intervention reach, effectiveness, adoption, implementation, and maintenance. 
 
Study Design 
This study employed a cluster randomized control trial intervention study design. Participants were 
assigned to either the advanced control group or culturally adapted decision support navigation 
intervention group 
 
Study Population 
Enrollment 
Twenty Chinese and Korean primary care physicians will participate in the study. Twenty Chinese and 
Korean American participants will be recruited from each participating primary care physicians’ clinics in 
Maryland and Northern Virginia (in total, 400 Chinese and Korean American patients will participate in 
the study). 
 
 
Inclusion Criteria 
Eligible participations met the following inclusion criteria: male and female Chinese and Korean 
American patients aged 50 to 75, who are not up to date for colorectal cancer screening. 
 
Exclusion Criteria 
Those with a family history, previous history of removing polyps, inflammatory bowel disease, or 
diagnosis of colorectal cancer. 

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Procedures 
(1) Ten primary care physician clinics will be randomized to advanced control and other 10 primary care 
physician clinics will be randomized to the culturally adapted decision support navigation intervention. 
Accordingly, 200 Chinese and Korean Americans (20 participants from 10 primary care physician clinics) 
will be randomized to the advanced control and other 200 Chinese and Korean Americans (20 
participants from 10 primary care physician clinics) will be randomized to the culturally adapted decision 
support navigation intervention. In total, 400 Chinese and Korean Americans will participate in this 
project. 
 
(2) All 400 participants will be invited to primary care physician’s clinic or community organization, 
where the participant will provide informed consent and HIPAA authorization form and complete a 
baseline survey (see sample). Participants’ height, weight and waist/hip circumference, blood pressure, 
blood glucose and cholesterol levels will be measured by trained research staff. 
 
(3) Those randomized to the advanced control group will receive informational booklet regarding 
colorectal cancer and colorectal cancer screening, colonoscopy instructions, stool blood test kit and a 
result of body measurements as a free service. They will receive a reminder by mail after 45 days of 
random assignment. 
 
(4) Those randomized to the culturally adapted decision support navigation intervention group will 
receive everything the advanced control receives, and will receive a phone call from a patient navigator. 
The patient navigator will verify the participant’s preferred colorectal cancer screening test. During this 
encounter, the patient navigator will also use a theory-based online Decision Counseling Program© to 
identify barriers to and facilitators of preferred test performance, determine the likelihood of test 
performance, and develop a personal screening plan. The counseling call will take about 45 minutes. The 
patient navigator will print out this screening plan and share it with the participant and primary care 
physician’s office. After 45 days of random assignment, those in the culturally adapted decision support 
navigation intervention group will receive a reminder by mail. 
 
(5) Six months after randomization, trained and blinded bilingual survey interviewers will contact each 
participant by telephone and administer a 6-month Survey. This will take about 20 minutes. Six-month 
medical record review will be also completed by the survey interviewer. 
 
(6) The patient navigator will create a colorectal cancer screening status report for participants in the 
culturally adapted decision support navigation intervention, and share it with the primary care physician 
and office manager. The report will indicate whether the participant adhered to the screening, and if the 
participant needs diagnostic follow-up for an abnormal stool blood test result. 
 
(7) At 12 months after randomization, an endpoint medical record review will be performed on all study 
participants to assess colorectal cancer screening adherence. Self-reported colorectal cancer screening 
data will be collected by phone. Survey interviewer will ask participants if they had colorectal cancer 
screening in past 6 months. 
 
Outcomes 
Participants will complete a pen and pencil questionnaire at baseline. At 6-month follow-up, 
participants will participate in phone survey and their medical records will be reviewed. At 12-months 
after randomization, the medical records of all participants will be reviewed by research team staff. 
Phone follow-up will be conducted to collect self-reported data on colorectal cancer screening. 
Previously validated measures to assess belief, attitude, cohesion, self-resilience and knowledge about 

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colorectal cancer screening and colorectal cancer, health literacy, religion, social support, acculturation 
and colorectal cancer screening adherence will be used in baseline and 6-month surveys. 
 
Primary Outcome Measure: 
• 
Colorectal Cancer Screening Adherence 
o Description: measure to assess colorectal cancer adherence among participants 
o Time Frame: at 6-month and at 12-month 
• 
Overall colorectal cancer screening adherence by self-report and medical record review 
o Description: measure overall colorectal cancer screening adherence by self-report and 
medical record review 
o Time Frame: at 6 months and at 12 months 
• 
Colorectal cancer screening decision stage for stool blood test and colonoscopy 
o Description: measure colorectal cancer screening decision stage for stool blood test at 
baseline and 6 month 
o Time Frame: Baseline and 6-month 
• 
Change in colorectal cancer screening decision stage for stool blood test and colonoscopy 
o Description: measure change in colorectal cancer screening decision stage for stool 
blood test and colonoscopy 
o Time Frame: 6 months 
• 
Colorectal cancer screening test-specific adherence for stool blood test and colonoscopy 
o Description: measure the fraction of participants who undergo a stool blood test and 
colonoscopy 
o Time Frame: at 6 months and at 12 months 

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Ethical Considerations 
This study was reviewed and approved by the University of Maryland, College Park Institutional Review 
Board. Prior to participation in the study, participants will provide informed consent. 
 
Potential Risks and Discomforts 
There are minimal risks to participants involved in this study. It is possible that thinking about cancer 
could cause stress or anxiety for some participants. Some participants may feel uncomfortable when 
the research team conducts body measurement. These are routine procedures that participants usually 
go through in their check-up; however, if they feel uncomfortable, participants can choose not to 
participate in it. Although somewhat likely, these risks are not considered serious because the 
questionnaires and body measurement assess only minimally sensitive issues and they pose little risk. 
Lastly, loss of confidentiality is always a risk with human participants; however we consider this risk 
minimal and have adopted multiple safeguards to ensure that confidentiality is protected. 
 
Benefits 
We believe there are benefits associated with learning about cancer screening and other health 
promotion behaviors. The intervention may increase the salience or awareness of the importance of 
these behaviors to participants. We also believe that learning about one’s body measurements will help 
them to maintain healthy lifestyle. Furthermore, the study may work as a reminder for participating 
primary care physicians to recommend colorectal cancer screening to their other patients who are not 
participating in the study. 
 
Confidentiality 
Confidentiality will be assured in the following way. Participants will be assigned a four-digit participant 
identification number, at the time of enrollment. Participant identifiers will be stored electronically in 
password-protected databases and in hard copies stored in locked file cabinets. In order to reduce the 
risk of loss of confidentiality, access to personal identification information will be limited to the study’s 
Principal Investigator (Dr. Lee) and the research staff. We have used these methods in past research and 
they have been extremely effective in protecting against potential risks. All research records will be kept 
for 10 years. After 10 years, all electronic records will be deleted from computer and all hard copies of 
data will be shredded.