Colorectal Cancer Screening Assessment Study in American Samoa
Phase: NA
Conditions: Colorectal Cancer
Sponsor: University of Hawaii

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Colorectal Cancer Screening Assessment Study in American Samoa  
NCT04500171- American Samoa Community Cancer Coalition and the UH Cancer Center 
Background / Statement of Need 
Brief Summary. 
Colorectal Cancer is the third most prevalent cancer in American Samoa for both men 
and women.  Fortunately, screening modalities such as FOBT, flexible sigmoidoscopy, and 
colonoscopy are available on island.  However, only 7% of eligible adults have reported 
receiving screening versus 62.9% in the U.S. (ASDOH, 20131).  Low and/or no participation in 
preventive health services is associated with knowledge deficits on health promotion behaviors. 
However, there were no studies to identify contributing knowledge risk factors and colorectal 
cancer screening within the indigenous Samoan population. In 2018 the Indigenous Samoan 
Partnership to Initiate Research Excellence (INSPIRE) conducted a pilot study to determine 
colorectal cancer (CRC) health literacy levels within the adult population 45 years or older in 
both English and Samoan using the Short-Test of Functional Health Literacy (S-TOFHLA). 
Results indicate 81% of the Samoan speaking (N=293) and 44% of the English speaking 
(N=418) participants demonstrated “inadequate” health literacy.  Accordingly, these groups are 
most likely to have difficulty reading, understanding, and interpreting health materials, directions 
for their health care and most likely to fail to follow prescribed diets or treatment regimens.  
Therefore, modifications must be made to CRC screening materials in order to enable the 
appropriate actions and understanding with these persons.    
Purpose and Primary Outcomes. 
This study, led by the American Samoa Community Cancer Coalition’s INdigenous 
Samoan Partnership to Initiatie Research Excellence (INSPIRE) and the UH Cancer Center’s 
project team including Dr. Cassel, will utilize a community-based and culturally relevant process 
to assess the uptake of fecal occult blood testing (FOBT) using tailored colorectal cancer patient 
education materials for those with inadequate health literacy.  Our primary outcomes include: 1) 
process to develop “suitable” and “comprehensible” health promotion materials for populations 
in English and Samoan with various health literacy levels, 2) commitment to use the FOBT 
Colocare home kit, and 3) use of a FOBT Colocare home kit.    
Study Overview  
Readability, Suitability, and Comprehensibility. 
Health literacy is defined by the Institute of Medicine as the “degree to which indivdiuals 
have the capacity to obtain, process, and understand basic health information and services 
needed to make appropriate health decisions.”  The s-TOFHLA has been used to determine 
individual health literacy in the indigenous population in American Samoa by the 2018 INSPIRE 
pilot study.  However, creating an effective health message that meets varying standards of 
health literacy levels is the next challenge in which this pilot project addresses.   
Creating appropriate messaging to initiate a behavior change involves more than 
readability.  The SMOG and Flesch-Kincaid tools determine grade level reading by the number 
of polysyllabic words in a paragraph or set number of sentences.  This is a limitation as it does 
not take into account factors that comprise a print message including numeric presentation, 
illustrations, motivators and reader interaction.  Realizing this, Doak et al., determined an 
improved method to assess the efficacy of patient education material (PEM) was the Suitability 
Assessment of Materials (SAM), and it evaluated 6 categories: content, literacy demand, 
graphics, layout/typography, learning stimulation and motivation, and cultural appropriateness.  
Helitzer et al. (2009), added terms to assess reading, calculating and solving problems creating 

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the Suitability and Comprehensibility Assessment of Materials (SAM + CAM).  The SAM + CAM 
is comprised of 22 evaluation items within the 6 original categories.  The instrument has been 
validated using 69 PEMs on cervical cancer care.  Thus, all PEM developed for this project will 
be evaluated using the SAM + CAM.               
 
Evidence-Based Model 
The proposed pilot study is a randomized controlled trial utilizing the evidence based 
program “Against Colorectal Cancer in Our Neighborhoods” (ACCION) for the Latino population 
in Texas as a guide. The health belief model and social cognitive theory were used as 
foundational principles to develop an intervention that builds awareness to initiate a CRC 
screening behavior modification.   
The program was administered in two separate counties (El Paso - intervention & Cameron - 
control) and used convenience smplaing methods.  Recruits in the intervention group were 
randomized into three areas: presentation only, video, only, or presentation plus video.  The 
control group was given the usual CRC screening protocol and no intervention components.  
Inclusion criteria were those age 50-75, being uninsured, lived in Texas, and being due for CRC 
screening.   
Results of the study show after a six month follow-up 80.5% (n=467) of the intervention 
group followed screening recommendations versus 17% (n=317) of the control group.  It is also 
notable there were no discernible differences in screening rates between the intervention 
methods.    
 
Material Development and Project Resources.  
 
Table 1 provides a brief summary of the Patient Education Materials (PEM) and the 
assessment tools that will be used to determine efficacy.  The project staff will use existing 
original materials developed by the ColoCARE manufacturer and the Centers for Disease 
Control and Prevention.  A brief instructional video will be created to accompany modified 
materials for the experiment group.   
 
 
 
Table 1. Brief Summary of Patient Education Material Development 
Control Group 
PEM 
English Original 
Assessment Tools 
Samoan Original 
Assessment Tools 
Colocare 
Instruction Sheet 
SAM + CAM 
SMOG  
SAM + CAM 
Cloze Procedure 
CDC Colorectal 
cancer screening 
for life brochure 
SAM + CAM 
SMOG 
SAM + CAM 
Cloze Procedure 
Experiment Group 
PEM 
English Modified 
Asessment Tools 
Samoan Modified 
Assessment Tools 
Colocare 
Instruction Sheet 
SAM + CAM – Superior rating 
SMOG – 5th Grade Level 
SAM + CAM – Superior rating 
Cloze Procedure 
CDC Colorectal 
Cancer Screening 
for Life Brochure 
SAM + CAM – Superior rating 
SMOG – 5th Grade Level 
SAM + CAM – Superior rating 
Cloze Procedure 
Colocare 
Instruction Video 
Modified SAM + CAM -Superior 
rating 
Modified SAM + CAM -Superior rating 

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ColoCARE Disposable Fecal Occult Blood Test 
The ColoCARE FOBT is cost effective and a simple way to detect presymptomatic bleeding 
caused by gastrointestinal diseases.  Based upon the design of a traditional guiac slide test, the 
test pad is placed in the toilet after a bowel movement.  The pad is treated with chomogen and if 
blood is detected will turn a blue and/or green color.  There is no requirement for lab staff or the 
handling of stool.  Each kit contains three pads, one large test square and two smaller control 
squares to verify the system is working properly.  Participants who are reported as symptomatic 
will be referred to the Lyndon Baines Johnson Tropical Medical Center (LBJTMC) for immediate 
follow up by clinical staff.     
 
Translation 
The translation of materials will be done in the following process: forward translation, 
synthesis, back translation, expert committee review and pretesting (Beaton et al., 2000).  The 
Samoan vocabulary can be described as limited compared to English.  The same Samoan 
word, or phrase, may be used to translate from English even if the PEM is revised to lower 
grade readability.  Consideration of the translations between the control and experiment groups 
will be discussed within the project staff and consulted with the expert committee.   
 
Assessment Tools: SAM + CAM, Samoan-s-TOFHLA, s-TOFHLA, and HINTS 
All original and modified PEMs in both languages will be administered by project staff and 
pre-testing group.  Each of the 22 items within the 6 identified categories are given a score of 0 
– 2 based upon certain criteria.  Total scores are calculated into percentages and 100% to 70% 
is superior, “69% to 40%” is “adequate”, while 39% - 0% is “not suitable”.The data gathered on 
the original materials will be used to develop the modified versions of the PEM.  The goal of the 
modified version is to achieve a rating of “superior”.  If the current PEM results in a “superior” 
rating efforts will be made to increase the modified versions to a higher percentage.        
The s-TOFHLA and Samoan-s-TOFHLA are timed reading comprehension tests that uses a 
modified Cloze procedure to measure understanding of the material.  Participants read 
sentences with missing words and circle the letter (either a, b, c, or d) in front of the word they 
feel would fit the best.  Individual results scored on a scale of 0 to 36. Participants are 
categorized as having “adequate” if the score is 23–36, “marginal” if it is 17–22, and 
“inadequate” health literacy if the score is 0–16 (Morris et al., 2006).  The s-TOFHLA is a 
reliable and valid instrument.  The Samoan-s-TOFHLA has been used in the INSPIRE study, 
however is currently being piloted tested in another study for validation. 
The Health Information National Trends Survey (HINTS) instrument was developed by the 
National Cancer Institute to monitor differential dynamics of communication in various cultural 
contexts to enhance communication strategies and messages effecting health behaviors. The 
instrument is capable of collecting data on over 23 cancer and health related topics. Our 
administration of HINTS will include items relevant towards improving the cancer prevention 
practices and health care utilization of the indigenous Samoan population.  The topics and items 
addressed by our use of HINTS will include: 1) Cancer Communications; 2) Cancer Perceptions 
and Knowledge; 3) Health Communications; 4) Internet Use; 5) Patient Provider 
Communications; 6) Risk Perceptions; 7) Social Networks; 8) Tobacco Use; 9) Health Services; 
10) Health Status. 
 
Simple Measure of Gobbledygook (SMOG) 
The SMOG is a readability assessment tool that uses a formula to calulate grade levels by 
the number of sentences, total number of words in the sentences, and the number of 
polysyllabic words.  The SMOG has been identified as reliable by the Centers for Medicare and 
Medicaid Services and considered a more appropriate metric for health materials.  The Joint 
Commission has recommended PEM is written at no higher then a 5th grade level for facilities 

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seeking accreditation.  However, the SMOG is not reliable to determine grade level of PEM 
translated into non-English languages.  Thus, SMOG will be used to determine the grade 
readability and number of polysyllabic words within the original English PEM.  The goal will be to 
modify the PEM for the experiment group to meet the Joint Commission’s recommendation.  
The modified PEM will be translated for use in the experiment group. 
 
Contextual Measure 
There is no known literature to determine the readability of the Samoan language.  
However, previous studies identify the cloze procedure, used in the s-TOFHLA, as a method to 
determine contextual meaning.  The use of a passage with missing text relies on the reader’s 
“redundancy utilization” or the knowledge of vocabulary, linguistic conventions, and general 
knowledge.  This allows for the reader to predict the context of the passage and is consistent 
with the natural reading process.  For this reason, all translated materials will be pretested using 
a cloze procedure.  Briefly, passages from the PEM will be provided to an individual who meets 
the eligibility criteria.  The PEM will have deleted words replaced by a blank line from the 
passage in regular intervals.  Under each blank line, the test taker will select one out of four 
options that will complete the passage.  The total score will reveal to the project staff if the 
translation is contextually understood.     
 
Sampling and Recruitment 
 
Program Sites.  
Project development, study recruitment and other related activities will take place at the 
American Samoa Community Cancer Coalition’s office in the village of Nu’uuli.  Centrally 
located, it is currently operating two separate studies utilizing RDS.  The use of a central point 
for the study and incentive payment makes it easier for participants to find.    
 
Recruitment of Participants.   
To recruit a final sample of 312 participants (English n=156, Samoan n=156), the project 
staff will initially recruit 24 participants as RDS seeds (12 men and 12 women; 12 English and 
12 Samoan).  Seeds will be required to meet eligibility requirements and known to have 
substantial social networks within the community.  These seeds will then each recruit a 
maximum of 3 additional community members. This recruitment pattern will continue to create 3 
consecutive recruitment waves (Wave 1, n=24; Wave 2, n=72; Wave 3, n=216).  This model will 
rely on the social networks of the paritipant to recruit and has been successful in the INSPIRE 
study that recruited 718 participants in 51 days.   
 
Participant Recruitment and Eligibility.  
Participants will be eligible if they: 1) are a resident of AS; 2) over age 50; 3) have not been 
diagnosed or treated for colon cancer; 4) are not high risk for CRC by having family history or 
diagnosed with irritable bowel syndrome; 5) can read and speak English and Samoan; 5) can 
provide written informed consent; 6) have a home address and working phone; and 7) are 
willing to provide information on their health behaviors. Exclusion criteria include persons who 
indicate they speak or read and write Samoan or English less than well.   
 
Intervention Participation 
 
Participants will be divided into English and Samoan subgroups based upon their RDS 
recruitment and language preference.  Next, participants will take the Samoan-s-TOFHLA or the 
s-TOFHLA, and the Heatlth Information National Trends Survey (HINTS).  Then, participants will 
be randomized into the control or experiment group (figure 1).  Participants in the control group 

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will receive a ColoCARE FOBT, ColoCARE Instruction Sheet, and the Centers for Disease 
Control and Prevention’s “Colorectal Cancer Screening Saves Lives” brochure in English and 
Samoan.  Participants selected in the experiment group will receive a ColoCARE FOBT, 
modified ColoCARE Instruction Sheet, ColoCARE instructional video, and a modified CDC 
“Colorectal Cancer Screening Saves Lives” brochure in English and Samoan.  The results will 
be reported to study staff by phone or in-person at the study center for data entry. 
Participants will be given a two week time period to complete the ColoCARE kit, report 
findings to program staff and recruit 3 additional participants. Participants will receive $10 during 
the initial intake screening and completion of the required assessments, $30 upon report of the 
ColoCARE results to study staff, and and additional $15 for each recruit who participates.  The 
total possible incentive for each participant is $85.  This tiered compensation plan is designed to 
address the increased burden on participants and reduce drop-out by incentivizing continued 
participation in the study.     
 
 
 
Figure 1.  Project Flowchart 

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RESEARCH SUBJECT INFORMATION AND CONSENT FORM 
 
TITLE: 
Colorectal Cancer Screening Assessment Study 
 
OFFICIAL TITLE:  
Colorectal Cancer Screening Assessment Study (Use this title for 
internet search on http://www.ClinicalTrials.gov) 
 
 
 
NCI PROTOCOL 
VERSION DATE: 
 
PROTOCOL NO.: 
Cassel-2020-1 
 
SPONSOR: 
University of Hawaii Cancer Center  
 
ClinicalTrials.gov 
IDENTIFIER: 
 
INVESTIGATOR: 
Victor Tofaeono, MD. 
 
American Samoa Community Cancer Coalition  
 
PO Box 1716 
 
Pago Pago, AS 96799 
 
STUDY-RELATED 
PHONE NUMBER(S): 
Victor Tofaeono, MD. 
 
(684) 699-0110 
 
 
University of Hawai‘i Cancer Center Clinical Trials Office 
 
808-586-2979 
 
 
 
 
 
 
 
 
 

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The University of Hawai’i Cancer Center and the American Samoa Community Cancer 
Coalition (ASCCC), are conducting a research study to explore the effectiveness of tailored 
colorectal cancer messaging to promoting healthy behaviors in Samoans. You have been 
preselected by the project staff or selected by a peer who believes that you meet the study 
criteria. 
PROCEDURES:   
Assessments: 
If you participate in this study, you will be first asked to take a brief survey about your 
knowledge of colorectal cancer.  Next, you will watch a five-minute educational video on 
colorectal cancer and take another brief survey about the video.  Then you will take the short-
Test of Functional Health Literacy in Adults (s-TOFHLA).  This assessment contains 
passages with missing words.  You must select the answer that best completes the passage.  
Your participation is strictly voluntary, and you can stop taking the survey at any time.  
Patient Education Materials (PEM): 
Upon your completion of the assessments, you will receive patient educational materials in 
the form of a brochure and instructional sheet on colorectal cancer and the ColoCARE Fecal 
Occult Blood Test (FOBT) home test kit. 
Colorectal Cancer (CRC) Screening: 
You will be provided a ColoCARE FOBT home test kit.  The research study staff will show 
you how to complete the test and how to use the reply card to report your results.  If a test has 
a positive result for possible blood in your stool, you will be referred to the Lyndon B. 
Johnson Tropical Medical Center (LBJ TMC) for further testing.    
Recruitment: 
You will be provided three coupons to recruit potential participants for the study.  The 
participants must also meet the eligibility criteria and provide consent. 
Time Commitment:  
Your participation in this study will take approximately one hour to complete the 
assessments, and two weeks for Colorectal Cancer Screening. Only the consenting 
participant will be permitted to take the assessment. 
 
BENEFITS AND RISKS:  
 
Assessments: 
We want to protect your privacy and ensure your comfort.  A possible risk of the study may be 
that answering certain survey questions may be uncomfortable.  Please let the researcher know at 
any time fi you do not feel comfortable taking the survey, talking about the survey or giving 
information for difficult questions, or if you would like to stop at any point. 

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Colorectal Cancer Screening: 
The ColoCARE test holds the potential benefit to find colorectal cancer at early stages when 
cure rates are higher.  As a result, there is a decrease in the percentage of colorectal cancer 
deaths using this early detection method.  However, no test is perfect.  Like any test or 
procedure, ColoCARE screening comes with risks.  The following risks may occur using the 
ColoCARE screening kit: 
 
1. The risk of a positive test that is colon cancer.   
2. The risk that the test will be negative, but colorectal cancer is present, also known as a 
false negative.   
3. The risk of a positive test but is not colorectal cancer, also known as a false positive. 
 
These risks are estimated to be low and, in some cases, have created anxiety.  However, in the 
event of a positive screening results, it may become necessary for further testing such as a 
colonoscopy, or flexible sigmoidoscopy, to make sure a positive test either represents 
colorectal cancer or does not.  If you have a positive result for blood in your stool, the project 
staff will take the necessary steps to ensure you are referred to a primary care physician at the 
LBJ Tropical Medical Center.  If you already have a primary care physician, it is highly 
recommended that you contact them immediately.   
 
Privacy and Confidentiality:  
All project data will be secured in a locked filing cabinet in a locked office or encrypted on a 
password protected computer. Only my supervisor or research mentor will have access to the 
information. Other agencies that have legal permission have the right to review research 
records. The institutional review board has the right to review records for this project. Your 
name will not be used in reporting the results of our project. Results will be used in a way that 
protects your privacy and confidentiality to the extent allowed by law. 
 
Voluntary Participation:  
Your participation in this project is completely voluntary. You may stop participating at any 
time. If you stop participation, there will be no penalty or loss to you. Your choice to 
participate or not participate will not affect your employment or rights to any services. 
 
Termination: 
At any point in time the investigators may terminate your participation in the study without 
your knowing or consent under certain circumstances including: 
- 
The sample size has been met 
- 
Your data file is incomplete 
- 
It is found that you have not met the eligibility criteria, after obtaining consent 
 
Any information you have provided will be removed from the study data set and will not be 
analyzed or published in any report or manuscript.   
 

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Options and Alternatives: 
Participation in the study is voluntary and you can leave at any time.  The only alternative is 
to not take part in this research study. 
 
Results: 
 
Assessments: 
For this study, your individual assessment results are being collected for research purposes 
and not to make a clinical diagnosis.  Additionally, results will not contain any identifiable 
indicators.  Therefore, your individual results will not be provided to you by the project staff.  
However, general study results will be disseminated to study participants first at a debriefing 
meeting.  The debriefing meeting date and location will be determined by the investigators.  
Afterwards, public release of study data will be done through various communication 
mediums including conferences, publications, newspapers, and social media.  
 
Colorectal Cancer Screening: 
For this study, you will be provided the results of your ColoCARE kit once completed as 
outlined in the instruction sheet.  You will be required to report those results via the Reply 
Card.  Although, these are your individual results they are being collected for research 
purposes and not to make a clinical diagnosis.  However, if you have a positive result 
during the study, then you will stop taking the study and be referred to your primary care 
physician or the Emergency Room at LBJ TMC by the project staff.  Any project data 
collected will be deidentified and grouped with other study participants by various 
demographics (e.g. education, age, gender, etc.) to be disseminated to study participants first 
at a debriefing meeting.  The debriefing meeting date and location will be determined by the 
investigators.  Afterwards, public release of study data will be done through various 
communication mediums including conferences, publications, newspapers, and social media.   
 
Additionally, you will be contacted by the investigators of any significant findings that are 
developed during the course of the research that may have an impact on your willingness to 
continue participating in the study via telephone call.   
 
 
What are the costs of taking part in this study? 
 
You may have transportation costs as part of your participation in this study.  Additionally, 
you will be responsible for any medical expenses resulting from participation in this study 
including but not limited to diagnostic, treatment, palliative care, and/or logistical expenses 
(e.g. airfare, gas, food, lodging, etc.) provided at LBJ TMC or outside of American Samoa.  
 
Sample size: The total number of participants needed for this study is 312.   
 

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Compensation: You will receive $10 in cash for when completing steps 1 & 2, $30 for step 3, 
and possibly $15 per individual recruit who successfully completes the project (maximum 3 
recruits). 
 
Questions: If you have any questions about this project, please call or email Mr. Va’a Tofaeono 
at (684) 699-0110 or vtofaeono@cancercoalition.as. 
 
Where can I get more information? 
 
You can talk to your doctor about any questions or concerns you have about this study. 
 
Contact your study doctor or Principal Investigator Victor Tofaeono, MD., at (684) 699-0110 
for any of the following reasons: 
 
• If you have any questions about this study or your part in it; or 
• If you feel you have had a research-related injury or bad reaction to the study drug. 
 
Contact the University of Hawai‘i Cancer Center Clinical Trials Office at 808-586-2979 for any 
of the following reasons: 
 
• If you have any questions about this study or your part in it; or 
• If you have questions, concerns or complaints about the research. 
 
If you have questions about your rights as a research subject or if you have questions, concerns or 
complaints about the research, you may contact: 
 
 
Western Institutional Review Board® (WIRB®) 
 
1019 39th Avenue SE Suite 120 
 
Puyallup, Washington  98374-2115 
 
Telephone:  1-800-562-4789 or 360-252-2500 
 
E-mail: Help@wirb.com 
 
WIRB is a group of people who independently review research. 
 
WIRB will not be able to answer some study-specific questions, such as questions about 
appointment times.  However, you may contact WIRB if the research staff cannot be reached or if 
you wish to talk to someone other than the research staff. 
 
You may also contact the University of Hawai‘i Cancer Center Compliance Office at: 
 
 
 

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University of Hawai‘i Cancer Center Compliance Office 
 
701 Ilalo St., Floor 6 
 
Honolulu, HI 96813 
 
Telephone:  1-808-564-5914 
 
For questions about your rights while in this study, you may call the Western Institutional 
Review Board at 1-800-562-4789.  You may also contact the Principal Investigator, Victor 
Tofaeono, MD., at (684) 699-0110, or the University of Hawai‘i Cancer Center Clinical Trials 
Office at 808-586-2979. 
sd 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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AUTHORIZATION TO USE AND DISCLOSE (RELEASE) IDENTIFIABLE HEALTH 
INFORMATION FOR RESEARCH 
 
1. What is the purpose of this form? 
 
University of Hawaii Cancer Center is an organization that does research to learn about the 
causes of cancer, and how to prevent and treat cancer. Researchers would like to use your 
personal health information for research. This information may include data that identifies you.  
 
The purposes of releasing your personal health information are to collect the data needed to 
complete the research, to properly monitor (watch) how the study is done, and to answer research 
questions related to this study. 
 
Please carefully review the information below. If you agree that researchers can use your 
personal health information, you must sign and date this form to give them your permission. 
 
2. What personal health information do the researchers want to use? 
 
The researchers want to copy and use the portions of your medical record that they will need for 
their research.  If you enter a University of Hawaii Cancer Center research study, information 
that will be used and/or released may include your complete medical record, and in particular, 
the following: 
• the history and diagnosis of your disease; 
• specific information about treatments you received, including previous treatment(s) you 
may have had; 
• information about other medical conditions that may affect your treatment; 
• medical data, including laboratory test results, tumor measurements, CT scans, MRIs, X-
rays, photographs of radiation therapy target areas, and pathology results; 
• information on side effects (adverse events) you may experience, and how these were 
treated; 
• long-term information about your general health status and the status of your disease; 
• data that may be related to tissue and/or blood samples that may be collected from you; 
and 
• numbers or codes that will identify you, such as your social security number, medical 
record number, initials, and date of birth. 
 
You may request a blank copy of the University of Hawaii Cancer Center data forms from the 
study doctor or his/her research staff to learn what information will be shared. 
 
3. Why do the researchers want my personal health information? 
 
The University of Hawai‘i Cancer Center will collect your health information and share it with 
the University of Hawaii Cancer Center  if you enter this research study. The University of 
Hawaii Cancer Center will use your information in their cancer research study. 
 

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TITLE: 
Colorectal Cancer Screening Assessment Study 
 
PROTOCOL NO.: 
Cassel-2020-1 
 
4. Who will be able to use my health information? 
 
By signing this form, you authorize the following parties to use and/or disclose your identifiable 
health information collected or created for this study: 
 
•  Victor Tofaeono, MD and his sub-investigators and research staff for the purposes of 
conducting this research study at research locations which have been approved by the 
Western Institutional Review Board. 
• Your primary care provider 
• Hospitals and providers that treat you 
• Laboratories that perform testing for the study 
• University of Hawai‘i Cancer Center 
 
Your medical records may contain information about AIDS or HIV infection, venereal disease, 
treatment for alcohol and/or drug abuse, or mental health or psychiatric services.  By signing this 
form, you authorize access to this information if it is in the records used by members of the research 
team. 
 
The University of Hawai‘i Cancer Center will use your health information for research.  As part 
of this research, they may give your information to the following groups taking part in the 
research.  The University of Hawai‘i Cancer Center may also permit the following groups to 
review your original records so that they can monitor their research study:  
• the University of Hawai‘i Cancer Center Operations Center; 
• the University of Hawai‘i Cancer Center Biostatistical Center; 
• the Cancer Trials Support Unit (CTSU), a research group sponsored by the National 
Cancer Institute that supports the research of University of Hawai‘i Cancer Center; 
• public health agencies and other government agencies, such as the U.S. Food and Drug 
Administration (FDA), and the Office for Human Research Protections (OHRP) in the 
U.S. Department of Health and Human Services (HHS), including non-U.S. agencies as 
authorized or required by law; 
• other people or organizations assisting with University of Hawai‘i Cancer Center 
research efforts. This may include drug manufacturers, drug companies that may provide 
partial support for the study, drug distributors, and/or their designees; 
• central laboratories, central review centers, and central reviewers.  The central 
laboratories and review agencies may also give your health information to those groups 
listed above; 
• the Western Institutional Review Board (WIRB), a group of people who review the 
research study to protect your rights; 
• the University of Hawai‘i Human Studies Program (UH IRB), the University’s review 
board; 

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• the University of Hawai‘i Cancer Center’s Office of Compliance for the purposes of 
overseeing the research study and making sure that your ethical rights are being 
protected; 
• IRBs and research groups of the medical institutions that work with the University of 
Hawai‘i Cancer Center; and 
• representatives of groups that audit studies to make sure the study is done as approved. 
 
5. How will information about me be kept private? 
 
University of Hawai‘i Cancer Center will keep all patient information private to the extent 
possible, even though University of Hawai‘i Cancer Center is not required to follow the federal 
privacy laws. Only researchers working with University of Hawai‘i Cancer Center will have 
access to your information. University of Hawai‘i Cancer Center will not release personal health 
information about you to others except as authorized or required by law. However, once your 
information is given to other organizations that are not required to follow federal privacy laws, 
we cannot assure that the information will remain protected.  When this happens, your 
information may lose its federal privacy protection and your information may be disclosed 
without your permission. 
 
6. What happens if I do not sign this permission form? 
 
If you do not sign this permission form, you will not be able to take part in the research study for 
which you are being considered.  If you choose not to be in the study or if you refuse to sign the 
authorization, it will not make a difference in your usual treatment, or your payment, and it will 
not change your eligibility for any health plan or health plan benefit that you are allowed. 
 
7. If I sign this form, will I automatically be entered into the research study? 
 
No, you cannot be entered into any research study without further discussion and separate 
consent. You must sign the study-specific consent form for this trial, Cassel-2020-1, “Colorectal 
Cancer Screening Assessment Study.” 
 
8. What happens if I want to withdraw my permission? 
 
You can change your mind at any time and withdraw your permission to allow your personal 
health information to be used in the research. If this happens, you must withdraw your 
permission in writing to the Principal Investigator listed on the first page of this form. Beginning 
on the date you withdraw your permission; no new personal health information will be used for 
research. However, researchers may continue to use the health information that was provided 
before you withdrew your permission.  
 
If you sign this form and enter the research study, but later change your mind and withdraw your 
permission, you will be removed from the research study at that time.  
 

Informed Consent for Clinical Research Protocols 
 
Cassel-2020-1 
 
Page 10 of 11 
To withdraw your permission, please contact the Principal Investigator. He will make sure your 
written request to withdraw your permission is processed correctly. 
 
INVESTIGATOR: 
Victor Tofaeono, MD. 
 
American Samoa Community Cancer Coalition  
 
PO Box 1716 
 
Pago Pago, AS 96799 
 
STUDY-RELATED 
PHONE NUMBER(S): 
Victor Tofaeono, MD. 
 
(684) 699-0110  
 
9. How long will this authorization last? 
 
If you agree by signing this form that researchers can use your identifiable health information, 
this authorization has no expiration date.  However, as stated above, you can change your mind 
and withdraw your permission at any time. 
 
10. What are my rights regarding my identifiable health information? 
 
You have the right to refuse to sign this authorization form.  You have the right to review and/or 
receive copies of your health records kept by the University of Hawai‘i Cancer Center.  You do 
not have the right to review and/or copy records kept by the University of Hawaii Cancer Center 
or other researchers associated with the research study. 
 
11. Who can answer questions related to my personal health information? 
 
You may contact the University of Hawai‘i Cancer Center Privacy Officer at: 
 
 
University of Hawai‘i Cancer Center Privacy Officer 
 
701 Ilalo St., Floor 6 
 
Honolulu, HI 96813 
 
Telephone:  1-808-564-5914 
 
 
Future contact 
 
I agree to be contacted by the University of Hawaii Cancer Center in the future regarding my 
participation in this study 
 
___________YES 
 
____________NO 
 
 
      (Please initial your choice) 
 
 
 

Informed Consent for Clinical Research Protocols 
 
Cassel-2020-1 
 
Page 11 of 11 
Signatures 
 
I have been given a copy of this consent form.  I have read it (or it has been read to me).  All my 
questions about the study and my part in it have been answered.  I freely consent to be in this 
research study. 
 
I authorize the use and disclosure of my health information to the parties listed in the HIPAA 
authorization section of this consent for the purposes described above.  
 
By signing this consent form, I have not given up any of my legal rights. 
 
 
 
Subject's Name  – PRINTED  
 
 
Date  
Signature of Subject  
 
 
 
Name of Person Conducting Informed Consent - PRINTED 
 
 
Date 
Signature of Person Conducting Informed Consent