Utilizing Technology to Promote Cancer Prevention
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Sponsor: University of Arkansas

 
 
 
 
 
Utilizing Technology to Promote Cancer Prevention 
 
 
08/05/2019 
 
 
NCT03810053 
 
 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 1 
Study Title: 
Utilizing Technology to Promote Cancer Prevention 
 
Principal Investigator: 
Mayumi Nakagawa, MD, PhD 
Pathology, College of Medicine, University of Arkansas for 
Medical Sciences 
Telephone: 501-686-8635 
E-mail: MNakagawa@uams.edu 
 
Sub-Investigator (s): 
Kristie Hadden, PhD 
College of Public Health, University of Arkansas for Medical 
Sciences 
Telephone: 501-686-2594 
E-mail: KBHADDEN@uams.edu 
 
 
Milan Bimali, PhD 
College of Public Health, University of Arkansas for Medical 
Sciences 
Telephone: 501-686-8204 
E-mail: MBimali@uams.edu 
 
 
Sumit K Shah, MD, MPH 
Pathology, College of Medicine, University of Arkansas for 
Medical Sciences 
Telephone: 501-526-5891 
E-mail: SSHAH3@uams.edu 
 
Study location: 
University of Arkansas for Medical Sciences 
4301 W Markham Street 
Little Rock, AR 72205 
 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 2 
Background and Rationale 
The cancer incidences are similar between Arkansas and the United States (US) 
population, but cancer-associated mortality in Arkansas is considerably higher in 
comparison to the US averages. This poses a huge burden on the public health as well 
as the healthcare system. In comparison to the US population, Arkansans are 14% 
more likely to die from cancer. With regards to cervical cancer, Arkansans are 30% 
more likely to be diagnosed, and 48% more likely to face cervical cancer-associated 
mortality. For lung cancer, there are 24% more diagnoses and 35% more mortality; 6% 
and 21% more for colorectal cancer; and 10% LESS and 4% more for breast cancer, 
respectively (Arkansas Cancer Facts & Figures 2017). While there are many reasons 
that can explain cancer health disparity between Arkansas and the US population, some 
obvious reasons are underutilization of recommended cancer prevention and early 
detection measures mentioned above and a relatively higher tobacco smoking rate. We 
will be targeting cervical, breast, colorectal and lung cancers with a focus on reducing 
cancer incidence and mortality rates amongst Arkansas residents and thereby mitigating 
cancer disparities in Arkansas. 
Specific Aims/Objectives 
The goal of the program is to develop a health application for cell phones or an online 
module which will be disseminated among Arkansans to encourage them to take actions 
to reduce their chance of developing cancer. This is a pilot study to test the mobile 
app/online module with a small group of volunteers residing in Arkansas who are 
registered in ARResearch. They will also be asked to provide feedback. The application 
or the didactic module would encourage and assist age- and gender-eligible participants 
to follow a healthier lifestyle and adopt cancer preventative and early detection 
measures. Eventually, in the future, the project will be open to all Arkansas residents 
with a long-term focus on reducing cancer incidence and mortality rates amongst 
Arkansas residents and thereby mitigating cancer disparities in Arkansas. 
Study Design and Procedures 
The application or the online module will play a short didactic explainer video that will 
provide information about cancers and benefits of uptake of cancer prevention and early 
detection measures. It is currently unknown which method will be used, the online 
module or the application for the purpose. However, all the study participants will be 
subjected to only one method (once the method have been finalized and created). The 
video content will engulf information about cervical, breast, colorectal and lung cancer 
prevention and early detection. After the video, the application or the module will capture 
information on gender, age, smoking status, body mass index and positive cancer 
history in family. Watching the video and answering the questions will take 
approximately 5 minutes. The study participants will download the application on their 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 3 
personal cell phones and the data collected will be linked to identifying information in 
case they choose to receive the compensation and opt for the 6-month follow-up. Based 
on the responses provided, and the age and the gender, the participants will be 
provided with a list of cancer prevention and early detection measure(s). In addition to 
providing their feedback online, they will have an option to call (501-526-5891) or e-mail 
(CancerPrevention.uams.edu) to provide additional input. 
A subset of the study participants from ARResearch (only those who have agreed for 
the 6-month follow-up) will be asked if they are willing to be contacted by the study staff 
after 6 ±1 months (from the date of enrollment in the study) to enquire if they 
received/adopted the screening measures(s) that were suggested based on their age, 
gender and family history. They will be asked whether it is OK to call and/or e-mail them 
for more information to better describe barriers to obtaining cancer prevention and 
screening measures. Mailing address, e-mail address, and phone number will be 
requested for the purpose of processing payment. 
The participants will be provided with a compensation in the form of gift card(s) for their 
initial participation in the amount of $40. They may also be eligible for 6-month follow-up 
which will provide an additional $40 gift card in compensation. Name, mailing address, 
e-mail address, and phone numbers will be collected to process the compensation, 
which will be mailed. Downloading the application or clicking on the link directing to the 
online module will serve an informed consent process and also as a permission to 
contact them in the future for processing payments electronically and follow-up for the 
respective and eligible participants. The online cancer prevention module (Appendix 1), 
feedback questions (Appendix 2), and 6-month follow-up questions (Appendix 3) are 
listed in the appendix section. 
Study Population 
We will obtain names, contact information, and preferred method of being contacted 
from ARResearch. As volunteers with any research interests can benefit from cancer 
prevention and early detection recommendations, all ARResearch volunteers would be 
eligible. As per TRI, they are all ≥ 18 years old. They will receive communication 
soliciting participating via e-mail or letter depending on the preference provided to 
ARResearch. For those who chose to be contacted by phone, the initial contact will be 
made by phone. A study staff will ask for an e-mail address or mailing address for the 
purposes of sending the solicitation. Up to 300 people can participate in this study. 
Inclusion Criteria 
• Any ARResearch volunteer. 
• 18 years or older in age. 
• Have access to a personal cell phone and/or computer 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 4 
Exclusion Criteria 
• Unable to give an informed consent. 
Risks and Benefits 
All participants will have the right to withdraw their consent and reject their voluntary 
participation at any time during the study without any penalty. The health application or 
the online module will be collecting names, e-mails and contact information to process 
compensations with the permissions of the participants. All the participants will be 
assigned and referred by a participant ID and all identifying information will remain 
confidential will only limited access to the study staff and it will not be disclosed or 
published anywhere. While only study staff will have access to the identifying 
information, a possibility of breach cannot be ruled out. 
There are no anticipated risks for the participants but it can potentially prove beneficial 
to the study participants since it will encourage the adoption of a healthier lifestyle 
and/or uptake of cancer prevention and early detection screening measures. The video 
will provide the participants with knowledge about the importance of cancer prevention 
and early detection measure(s) and the questions will provide with a to-do action list for 
relevant cancer prevention and early detection measure(s). 
Data Handling and Recordkeeping 
Data will be stored on a password-secured UAMS server with only authorized personnel 
having limited access to the information. All data will be in the form of electronic files 
while any hard copies of source documents will be store in double-locked cabinets on 
UAMS campus. All data will be retained, and ultimately destroyed as per the UAMS 
policy. All the participants will be assigned and referred by a participant ID and all 
identifying information will remain confidential will only limited access to the study staff 
and it will not be disclosed or published anywhere. While only study staff will have 
access to the identifying information, a possibility of breach cannot be ruled out. 
Data Analysis 
Basic descriptive statistics will be used to summarize the data. The effectiveness of the 
online module will be assessed by asking whether the participants learned anything 
new, and whether they’ve identified interventions they have not yet adopted. If HPV 
vaccination, mammography, Pap smear, low-dose compute tomography (LDCT) and/or 
colorectal cancer screening was(were) identified as measure(s) the individual has not 
yet adapted, a 6-month follow-up questionnaire will be forwarded to assess progress if 
the participant agreed to participate in the 6-month follow-up survey. 
 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 5 
Future directions 
We intend to take this initiative further to increase cancer awareness and reduce cancer 
health disparity by seeking extramural funding in the future to develop similar 
applications or similar online modules which will be open for all Arkansas residents. 
Applications or modules will be submitted to organizations that support development of 
newer programs for promoting cancer prevention and early detection such as the 
National Cancer Institute (R01 and/or R21), American Cancer Society, and American 
Association for Cancer Research. In particular, investigators plan to prepare an 
application responding to PAR-18-639: Innovative Approaches to Studying Cancer 
Communication in the New Media Environment (R21- Clinical Trial Optional) or to PAR-
18-638: Innovative Approaches to Studying Cancer Communication in the New Media 
Environment (R01 Clinical Trial Optional). 
Ethical Considerations 
This study will be conducted in accordance with all applicable government regulations 
and UAMS research policies and procedures. This protocol and any amendments will be 
submitted and approved by the UAMS Institutional Review Board (IRB) to conduct the 
study. A waiver of documentation of consent is requested since there will be no in-
person contact between the respondents and the study staff. Voluntarily downloading 
the application or accessing the online module will serve as the informed consent 
process. 
Dissemination of Data 
Results of this study may be used for presentations, posters, or publications. The 
publications will not contain any identifiable information that could be linked to any 
participants. 
 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 6 
References: 
1. Arkansas Cancer Facts and Figures 2017. Arkansas Department of Health. 
 
 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 7 
Appendix 1: Online Cancer Prevention Module 
Animation Video Script 
No one wants cancer…. so, what is it exactly and how can you prevent it? 
 
Cancer is abnormal, uncontrolled cell growth that can start in different areas of the body. 
 
The growth is caused by changes in your genes that are inherited or from chemicals and 
viruses. 
 
Once it starts, cancer can spread and grow in other parts of the body… causing pain, loss 
of normal function, or even death. 
 
Only certain kinds of cancer can be prevented, and everyone’s chances of getting it are 
different. 
 
But there are things you can do right now, before cancer becomes a problem. 
 
Screenings like a mammography, pap smear, or a colorectal cancer screening can help 
doctors find signs of cancer early. 
 
Getting an HPV vaccination helps your body produce a substance that stops HPV if you’re 
ever exposed. 
 
Losing weight and quitting smoking can help too. 
 
To find out what you can do to lower your risk, answer the following questions. 
 
Questions 
1. What is your sex? 
a. Male 
b. Female 
c. Neither 
 
2. What is your age (enter a whole number)? 
 
3. Have you ever smoked? 
a. Yes (Go to question 4) 
b. No (Go to question 8) 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 8 
4. Do you currently smoke? 
a. Yes (Go to question 6) 
b. No (Go to question 5) 
 
5. When did you quit smoking? 
a. Less than or about 15 years ago 
b. More than 15 years ago 
 
6. How many packs per day do you smoke or did you smoke? 
0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, ≥20 
 
7. How many years have you or did you smoke? 
<1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 
27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, ≥50 
 
8. What is your weight, in pounds? 
 
9. What is your height, in feet and inches? 
 
10. (Women only) Has your mother, any of your sisters, or any of your daughters had breast 
cancer? 
a. Yes 
b. No 
 
11. Has anyone in your family ever had colon or rectal cancer? 
a. Yes 
b. No 
 
 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 9 
[List of action items for cancer prevention and early detection will appear here possibly 
including…] 
• 
These actions are recommended for you: 
• 
HPV vaccination (need 2 to 3 doses) 
• 
Mammography every 2 years 
• 
Pap smear every 3 or 5 years (if with HPV testing) 
• 
Colorectal cancer screening (every 1 to 10 years depending on method) 
• 
Low-dose computed tomography (LDCT), every year 
• 
Stop smoking 
• 
Lose weight 
 
12. Did this list help you learn about any actions you did not know about?  
a. Yes (If yes, which one: HPV vaccination, mammography, Pap smear, colorectal 
cancer screening, low-dose computed tomography (LDCT), stop smoking, lose 
weight) 
b. No 
 
13. Did this list help you learn about any actions you have not taken yet? 
a. Yes (If yes, which one: HPV vaccination, mammography, Pap smear, colorectal 
cancer screening, low-dose computed tomography (LDCT), stop smoking, lose 
weight) 
b. No 
 
14. [If Yes for question 13 and showed willingness to receive HPV vaccination, 
mammography, Pap smear, colorectal cancer screening or low-dose computed 
tomography] Can we contact you in about 6 months to see whether you were able to 
these take action (s)? If we are able to re-contact you, you’ll receive $40 worth of gift 
card(s) as a compensation for participating in the 6-month follow-up survey. 
a. Yes 
b. No 
 
 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 10 
Thank you for answering the survey. Since you have completed the survey and if you are 
willing to provide feedback, you will be eligible for $40 worth of gift card(s). Please provide 
more information below if you wish to proceed: 
 
15. Contact information 
1. Name: Free text 
2. E-mail address: Free text 
3. Phone number: Free text 
 
16. Race 
(a) American Indian or Alaska Native 
(b) Asian 
(c) Native Hawaiian or Other Pacific Islander 
(d) Black or African American 
(e) White 
(f) More than one race 
(g) Don’t know 
 
17. Ethnicity 
(a) Non-Hispanic or Latino 
(b) Hispanic or Latino 
(c) Don’t know 
 
18. How confident are you filling out medical forms by yourself? 
(a) Not at all 
(b) A little bit 
(c) Somewhat 
(d) Quite a bit 
(e) Extremely 
 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 11 
Appendix 2: Feedback Questions 
 
1. I liked the animation video. 
a. Strongly agree 
b. Agree 
c. Neutral 
d. Disagree 
e. Strongly disagree 
 
2. The animation video was entertaining. 
a. Strongly agree 
b. Agree 
c. Neutral 
d. Disagree 
e. Strongly disagree 
 
3. I learned something new from the animation video. 
a. Strongly agree 
b. Agree 
c. Neutral 
d. Disagree 
e. Strongly disagree 
 
4. After watching the video, I felt encourage to take actions towards reducing my changes 
of suffering from cancer. 
a. Strongly agree 
b. Agree 
c. Neutral 
d. Disagree 
e. Strongly disagree 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 12 
5. After watching the video, I felt encouraged to tell others about cancer prevention and 
early detection. 
a. Strongly agree 
b. Agree 
c. Neutral 
d. Disagree 
e. Strongly disagree 
 
6. The questions following the video were easy to answer. 
a. Strongly agree 
b. Agree 
c. Neutral 
d. Disagree 
e. Strongly disagree 
 
7. I found the list of recommendations to prevent cancer helpful for me personally. 
a. Strongly agree 
b. Agree 
c. Neutral 
d. Disagree 
e. Strongly disagree 
 
8. I would recommend this cancer prevention module to my friends and family through 
social media. 
a. Strongly agree 
b. Agree 
c. Neutral 
d. Disagree 
e. Strongly disagree 
 
 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 13 
9. Which social media would you use (choose all that apply). 
a. Facebook 
b. Twitter 
c. Instagram 
d. Snap Chat 
e. Other 
i. Specify [free text] 
 
10. Do you work and/or study in a healthcare field? 
a. Yes 
b. No 
 
11. What is your highest level of education? 
a. Less than high school 
b. Finished high school/GED 
c. Less than college 
d. Finished college 
e. More than college 
 
12. Which would be the most desirable compensation/prize for doing the online cancer 
prevention module when the module is widely disseminated to the general public? 
Please note as a participant in this pilot study through ARResearch, you will receive a 
$40 gift card for doing the module and providing a feedback. 
a. A chance to win a $500 gift card 
b. A chance to win an iPad 
c. A chance to win 2 Razorbacks football tickets 
d. Other 
i. Specify [free text] 
 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 14 
13. Which would be the most desirable compensation/prize for the 6-month follow-up when 
the module is widely disseminated to the general public? (as a participant from 
ARResearch you will be eligible to receive a $40 gift card if you decide to sign up). 
a. $10 gift card for each participant 
b. A chance to win $500 gift card 
c. A chance to win an iPad 
d. A chance to win 2 Razorbacks football tickets 
e. Other 
i. Specify [free text] 
 
14. If you have any additional suggestions to improve this program, please write here [free 
text]. 
You can also send an e-mail to CancerPrevention@uams.edu or call 501-526-5891 to 
provide feedback. 
 
15. Contact information for processing payment 
a. Name: Free text 
b. Address: Free text 
c. E-mail address: Free text 
d. Phone number: Free text 
 
 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 15 
Appendix 3: 6-month follow-up questions 
Only question(s) about cancer prevention measure(s) found not to be up to date in the 
original survey would be asked. 
1. HPV vaccination 
a. Were you able to receive at least one dose of HPV vaccination? 
i. Yes 
1. If yes, where did you get it? 
a. Doctor’s office 
b. Arkansas Department of Health 
c. Pharmacy 
d. Other [specify] 
ii. No 
1. If no, did you make any attempt? 
a. Yes 
i. What happened? [free text] 
b. No 
2. Mammography 
a. Were you able to get a mammography? 
i. Yes 
1. If yes, where did you get it? 
a. Doctor’s office 
b. Mammovan 
c. Other [specify] 
ii. No 
1. If no, did you make any attempt? 
a. Yes 
i. What happened? [free text] 
b. No 
 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 16 
3. Pap smear 
a. Were you able to get a Pap smear? 
i. Yes 
1. If yes, where did you get it? 
a. Doctor’s office 
b. Arkansas Department of Health 
c. Mammovan 
d. Other [specify] 
ii. No 
1. If no, did you make any attempt? 
a. Yes 
i. What happened? [free text] 
b. No 
4. Colorectal cancer screening 
a. Were you able to get any of the colorectal cancer screening tests? 
i. Yes 
1. If yes, which test did you get? 
a. Colonoscopy 
b. Colonography/Sigmoidoscopy 
c. FIT test 
d. Other [specify] 
2. If yes, where did you get it? 
a. Doctor’s office 
b. Gastroenterology center 
c. Hospital 
d. Other [specify] 
 
 

Title: 
Utilizing Technology to Promote Cancer Prevention 
PI: 
Mayumi Nakagawa, MD, PhD 
Site: 
University of Arkansas for Medical Sciences 
Version #: 1.7 
IRB# 228815 
Date: 
08/05/2019 
Page 17 
ii. No 
1. If no, did you make any attempt? 
a. Yes 
i. What happened? [free text] 
b. No 
5. Lung cancer screening (Low-dose computed tomography) 
a. Were you able to get a low-dose computed tomography? 
i. Yes 
1. If yes, where did you get it? 
a. Hospital/Healthcare institution 
b. Other [specify] 
ii. No 
1. If no, did you make any attempt? 
a. Yes 
i. What happened? [free text] 
b. No 
 
6. Is it OK to call and/or e-mail you for more information? 
a. Yes (fill out contact information below) 
b. No 
 
7. Please provide current contact information for processing your payment 
a. Name: Free text 
b. Address: Free text 
c. E-mail address: Free text 
d. Phone number: Free text