Increasing CRC Screening Using Audio and Video Brochures: A Pilot Randomized Controlled Trial
Phase: NA
Conditions: Colorectal Carcinoma
Sponsor: Ohio State University Comprehensive Cancer Center

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Increasing CRC Screening Using Audio and Video Brochures: 
A Pilot Randomized Controlled Trial 
 
 
Principal Investigator 
Mira L. Katz, PhD, MPH 
Professor 
Division of Health Behavior and Health Promotion 
College of Public Health 
Suite 525 Gateway 
mira.katz@osumc.edu 
 
 
 
Co-Investigators 
Paul L. Reiter, PhD 
Associate Professor 
Division of Health Behavior and Health Promotion 
College of Public Health 
359B Cunz Hall 
reiter.36@osu.edu 
 
Hisham Hussan, M.D. 
Assistant Professor 
College of Medicine 
410 W 10th Ave 
Hisham.Hussan@osumc.edu 
 
Abigail Shoben, PhD 
Associate Professor 
Division of Biostatistics 
College of Public Health 
249 Cunz Hall 
shoben.1@osu.edu 

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disposable gloves, a dish sample collection device, and a mailed reminder. Both developed FIT 
outreach interventions will be compared to usual care (FIT, manufacturer’s instructions). 
Currently, FIT outreach programs are used in the United States. It is important to mail the FIT kits to 
patients without prior consent to reduce the selection bias that would occur if consent was obtained 
prior to the mailing. Patients will be mailed a notification letter one week prior to mailing the FIT kits and 
may contact the health center to opt out of future mailings. 
 
2. SPECIFIC AIM 
The specific aim for this study is to: Conduct a pilot study of the two developed mail-based FIT 
outreach interventions vs. mailed usual care materials to establish acceptability and obtain 
preliminary efficacy data on increasing CRC screening. Hypothesis A. FIT return and CRC 
screening process (primary outcome) will be higher among mid-life adults in both intervention groups 
(audio or video brochures) compared to those in the usual care group (preliminary efficacy). Hypothesis 
B. Mid-life adults in both intervention groups will have higher satisfaction with materials compared to 
those in the usual care group (intervention acceptability). 
 
3. METHODS 
Pilot Study: Randomized Controlled Trial 
Conceptual Model. 
The intervention will be guided by 
the Protection Motivation Theory 
(PMT; 
Figure 
2).22 Constructs 
include: intrinsic/extrinsic rewards 
of 
the 
maladaptive 
response 
(concerns about adverse events, 
negative 
social 
norms); 
severity/susceptibility 
(perceived 
CRC severity and vulnerability); 
response 
efficacy 
(FIT 
effectiveness);  
self-efficacy 
(confidence to complete FIT); and 
response 
costs 
(screening 
barriers).  Fear  is  a  mediating 
variable between severity and vulnerability and intention and focuses on CRC worry. 
 
Eligibility/ Recruitment. 
A list of patients will be generated at the participating health system (COMPASS Community Health 
Center; letter of support Appendix A) of mid-life men and women (50-64 years old) who: 1) live in 
Appalachia; 2) had a medical visit in the past two years; 3) are at average-risk for CRC (no history of 
CRC, polyps, inflammatory bowel disease, family history of CRC or hereditary CRC syndromes); and 4) are not 
within CRC screening guidelines (no fecal occult blood test/FIT in the past year; flexible sigmoidoscopy 
in past five years; colonoscopy in past ten years).4 Only one person per household will be able to 
participate in the study to avoid any bias. The Compass Community Health Center will share patient 
names and addresses with Dr. Katz at OSU using secure email for all communication. 

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Randomization. 
The selected patients will be randomized to 
the: 1) usual care group; 2) audio brochure 
group; or 3) video brochure group. A random 
number generator will be used and a 1:2:2 
allocation scheme (stratified by gender). We 
will continue until 160 patients have been 
randomized (Figure 3). 
Intervention Groups. 
The intervention groups will be sent (Table 1) 
a Notification letter (Appendix B) about the 
CRC screening study. If an individual opts out 
of participation in the study, there information 
will not be retained and their information will 
be deleted from the file by Dr. Katz when she 
is notified by the health center. 
Approximately 7 days later, patients will be sent a kit that includes an Information Sheet (Appendix C) 
explaining the content of the kit and instructions on what to do depending on the group assignment. 
FIT. The test and postage-paid return addressed envelope is included with the manufacturer’s FIT 
instructions (Appendix D). An audio brochure or video brochure (described next) will be included in the 
kit. Participants only have to place their name, date of birth, and the date of their sample collection on 
the requisition form and the specimen collection bottle. They will be able to put the completed FIT in 
the mail using the return stamped addressed envelope. 
Audio Brochure or Video Brochure. The audio brochure cover (Appendix E) and audio script 
(Appendix F) or video brochure cover (Appendix G) and video script (Appendix H) will provide targeted 
CRC screening information (6 minutes and 45 seconds) and will include FIT instructions (5 minutes and 
30 seconds) in a format that will be engaging for individuals with limited health literacy. We enhanced 
the cultural appropriateness of the intervention by featuring pictures of individuals who look like adults 
from the Appalachian community and healthcare providers focusing on the CRC burden among 
Appalachian residents since targeted health information improves health outcomes.23-25 Due to COVID-
19, we were not able to film the videos in Appalachia. We are using narrative over high quality 
photographs that were reviewed and chosen by community input (community members and healthcare 
providers). The intervention content targets PMT constructs (described in Conceptual Model section). 
We included testimonials for likeness between source and receiver; improving cultural similarity and 
message relevance. 
Disposable Gloves. To address the screening barrier about the concern with the messiness 
associated with FIT completion, we will include disposable gloves that can be worn during specimen 
collection. 
Collection Device. To assist with the collection of the stool sample, we are also including a dish 
collection device that makes it easier to collect a stool sample. 
Patient survey (Appendix I: audio brochure group; Appendix J: video brochure group) and Medical 
Record Release (MRR) form (Appendix K) will be included in the kit with the FIT test. The survey 
assesses demographic characteristics (e.g. race, education, etc. and telephone number), PMT 
constructs (e.g. screening barriers)26, health literacy27, perception of access to quality medical care, 
and satisfaction with educational materials using modified items from an existing satisfaction scale 
(Likert-type items).28. Patients will be asked to complete the survey even if they do not complete and 
return the FIT. Return of the survey will imply consent and participants will receive a $25 gift card for 

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completing the survey and a $5 gift card for the return of the signed MRR (Appendix L). Gift cards will 
be mailed to participants within three business days after receipt of the signed documents. Participants 
will not have to answer any survey questions they do not want to answer. Participants will be allowed 
to return the FIT without the survey or MRR. We will call patients who return the survey to decrease 
missing data, if needed. Based on our previous research, we expect 85% will return the survey and 
70% will return a MRR. We will include a stamped addressed return envelope so individuals may return 
the documents. 
Mailed Reminder (if necessary). A mailed reminder (Appendix M) will be sent to participants who 
have not completed the FIT about two weeks after the initial FIT test mailing based on community input. 
Previous research has shown that FITs are usually returned within a few months.16, 19 Participants may 
request a 2nd FIT if they misplaced the first FIT. The study’s primary outcome is based on if an individual 
returns or does not complete the FIT test at two months. 
 
Table 1. Components of Usual Care Group and Intervention Groups 
Component 
Group(s) 
Description 
Theoretical Constructs 
Notification Letter 
All 
• Recommendation for CRC screening 
N/A 
Patient Survey 
All 
• Demographic information 
• CRC screening history 
• FIT barriers/facilitators 
• Satisfaction with materials 
• Severity, susceptibility 
• Rewards, response costs 
• Self-efficacy, Response-efficacy 
• Fear/worry 
Medical Record 
Release 
All 
• Release of CRC screening results 
N/A 
FIT 
Usual Care 
• Manufacturing company FIT instructions 
N/A 
FIT 
Audio 
• Provides information about CRC screening 
• Brochure with targeted CRC information for 
residents of Appalachia, and testimonials 
• Provides step by step FIT audio 
instructions 
• Severity, susceptibility, response efficacy 
• Rewards: Concerns and social norms 
• Fear/worry 
• Self-efficacy, response efficacy, response 
costs 
FIT 
Video 
• Provides information about CRC screening 
• Brochure with targeted CRC information for 
residents of Appalachia, and testimonials 
• Provides step by step FIT visual and audio 
instructions 
• Severity, susceptibility, response efficacy 
• Rewards: Concerns and social norms 
• Fear/worry 
• Self-efficacy, response efficacy, response 
costs 
Disposable Gloves 
Audio/Video • Addresses a common patient barrier 
(“messiness”) 
• Response Costs 
Dish Stool 
Collection Device 
Audio/Video • Addresses a common patient barrier 
(ease of collection) 
• Response Costs 
Screening 
reminders 
(if needed ) 
Audio/Video • Mailed reminder about the importance of 
completing CRC screening (FIT) 
• Rewards, response costs 
• Self-efficacy, Response-efficacy 
 
Usual Care Group. 
The usual care group will be sent a Notification letter. This letter will be Identical to intervention groups 
(Appendix B). 
One week later patients will be sent a kit (Table 1) that includes an Information Sheet (Appendix C) 
explaining the content of the kit and instructions on what to do based on the group assignment. 
FIT. The test and postage-paid addressed return envelope is included with the manufacturer’s FIT 
instructions (Appendix D). Participants only have to place their name, date of birth, and the date of their 
sample collection on the requisition form and specimen collection bottle. They will be able to put the 
completed FIT in the mail using the return stamped addressed envelope. The FIT test will be sent 

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directly to the laboratory that works with the community health center. The FIT test will not be sent to 
OSU. 
Patient survey (Appendix N) and Medical Record Release (MRR) form (Appendix K). The survey 
assesses demographic characteristics (e.g. race, education, etc. and telephone number), PMT 
constructs (e.g. screening barriers)26, health literacy27, perception of access to quality medical care, 
and satisfaction with educational materials using modified items from an existing satisfaction scale 
(Likert-type items).28 Patients will be asked to complete the survey even if they do not complete and 
return the FIT. Return of the survey will imply consent and participants will receive a $25 gift card for 
completing the survey and a $5 gift card for the return of a signed MRR (Appendix L). Gift cards will be 
mailed to participants within three business days after receipt of the signed documents. Participants 
will be allowed to return the FIT without the survey or MRR. We will call patients who return the survey 
to decrease missing data, if needed. Based on our previous research, we expect 85% will return the 
survey and 70% will return a MRR. We will include a stamped addressed return envelope with the 
documents. Identical to intervention groups, participants may request a 2nd FIT if they misplaced the 
first FIT. The study’s primary outcome is based on if an individual returns or does not complete the FIT 
test. 
Surveys. The surveys will be designed using Teleform software by the Recruitment, Intervention and 
Survey Shared Resource (RISSR). This paper-based data collection software reduces error associated 
with data entry and directly inputs data into a database that is saved behind the OSU firewall. 
Study Primary Outcome: FIT Return. 
FIT return at 2 months will be the primary outcome of this pilot study. 
 
FIT Results and Follow-Up. 
The laboratory will send FIT results to the health center and participants will be notified of results per 
the health center’s regular protocol. Participants with normal FITs will be mailed results including an 
explanation of the results and the importance of annual FIT completion. Participants with positive FITs 
will be called by the healthcare system to discuss results and will be referred for colonoscopy using 
current referral process. Participants with a positive FIT that cannot be reached by multiple attempts by 
telephone will be sent a letter instructing them to call the clinic for the FIT results. For participants who 
provide MRR, we will document FIT results. We will also document subsequent referral for colonoscopy, 
other CRC tests (e.g. colonoscopy) completed, and test results. Dr. Hussan will assist with issues 
associated with follow-up of positive FIT that may arise during the study, if needed (all participants). If 
we do not have a signed MRR, the healthcare system will send us group data by study arm. 
 
Data Analysis. 
The specific aim of this proposal is to conduct a pilot study of the two developed mail-based FIT 
outreach interventions vs. mailed usual care materials to establish acceptability and obtain preliminary 
efficacy data on increasing CRC screening. Large sample sizes will not be required to achieve these 
goals. Hypothesis A. Mid-life adults in both intervention groups will have higher satisfaction with 
materials compared to those in the usual care group (intervention acceptability). Linear regression will 
be used to compare means and estimate differences (intent-to-treat analysis). These acceptability data 
will be critical to our subsequent application. Hypothesis B. FIT return (primary outcome) will be higher 
among mid-life adults in both intervention groups (audio or video brochures) compared to those in the 
usual care group (preliminary efficacy). We will randomize 64 patients in each intervention arm and 32 
patients in the control arm (160 total, stratified for gender in each arm). This sample size will also allow 
us to characterize proportions +/-6% and means +/-0.13 standard deviation units in each intervention 
arm. We will estimate FIT return (primary outcome) using proportions for each study group. We assume 

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a return rate of 20% in control arm, 40% in audio brochure arm (OR=2.7), and 50% in video brochure 
arm (OR=4.0) based on the literature. Both comparisons (each intervention compared to control) will 
be a two-sample test of proportions (intent-to-treat analysis) using a one-sided alpha of 0.1 due to the 
preliminary nature of the study. With these assumptions, we have 96% power for the test of the video 
intervention and 77% power for the test of the audio intervention. We know that we will not be powered 
to detect small effect sizes or conduct sophisticated analyses (e.g. gender differences). We will estimate 
critical parameters with point estimates and 95% confidence intervals and provide a preliminary test of 
effectiveness on FIT completion. Results will provide preliminary data that will help power the future 
larger RCT. Data between the healthcare system and the OSU research team will be by secure 
encrypted email (Appendix O) 
 
Survey Non-Responders. 
Due to the low return of completed surveys, an additional follow-up will be conducted. A letter 
from the health center participating in this study will be sent to patients who have not returned a 
completed survey and: a) who have not completed the FIT test (Appendix AA), or b) who have 
completed the FIT test. If a patient calls the toll-free number and is willing to complete the 
telephone interview, a script (Appendix CC) will be read prior to starting the interview that will 
include obtaining verbal consent for the telephone interview.  
 
After verbal consent has been received, the interview will start. A few introductory questions 
and the interview guides (Appendix DD) are the approved surveys with a few less questions to 
decrease burden. The six different interview guides are based on what arm of the study (usual 
care, audio brochure, video brochure) the person was sent and whether they completed or did 
not complete the FIT test. Participants will be mailed the $25 gift card if they complete the 
telephone interview. This additional opportunity to collect information from patients is important 
for revising the intervention prior to testing in a future trial.  
4. Privacy of Participants. 
Precautions will be taken to protect the privacy of the participants. Identification numbers will be used 
instead of the names of participants on study forms and in the database containing survey data. The 
OSU study team will keep a separate file with study ID numbers and patient names (Appendix P). Only 
Dr. Katz at OSU will have access to the file with the names and addresses and participant ID numbers 
and this information will be password protected behind the OSU Medical Center firewall. The names, 
addresses, and participant ID numbers will also be known by the health center so that all further 
communication between Dr. Katz and the health center will be by using participant ID numbers. Patient 
surveys and signed medical record release forms will be stored in locked file cabinets behind locked 
doors in Dr. Katz’s office. All study-related databases will be password protected behind the OSU 
firewall and any other documents will be stored in locked file cabinets behind locked doors. In addition, 
all study-related activities will take place in the home of the participants, which helps to protect their 
privacy. 
We believe this study presents only minimal risk to participants, which is far outweighed by the potential 
benefit to both the participants and society in general. Colorectal cancer screening by a recommended 
screening test is an important health-related issue for adults living in Appalachia, and this study will 
provide knowledge about a new method to increase screening among this high-risk population. 
 
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