Reducing Colorectal Cancer Health Disparities: An mHealth Intervention to Improve Screening Among African American Men
Phase: NA
Conditions: Colorectal Cancer
Sponsor: ISA Associates, Inc.

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Protocol Number: R44CA246899 
National Clinical Trial (NCT) Identified Number:  NCT06052202 
Principal Investigator*: Samantha Leaf 
Sponsor: ISA Associates, Inc. 
 
Grant Title: Reducing Colorectal Cancer Health Disparities: An mHealth Intervention to Improve 
Screening among African American Men 
Grant Number: R44 CA246899-02A1 
Funded by: National Cancer Institute 
Version Number:  v.1 
10/19/2024 
 
 
 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
NIH terms of award.  
 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
INVESTIGATOR’S SIGNATURE .............................................................................................................................. 2 
1 
PROTOCOL SUMMARY ............................................................................................................................... 3 
1.1 
Synopsis ................................................................................................................................................ 3 
1.2 
Schema ................................................................................................................................................. 3 
1.3 
Schedule of Activities .......................................................................................................................... 5 
2 
INTRODUCTION ............................................................................................................................................ 6 
2.1 
Study Rationale .................................................................................................................................... 6 
2.2 
Background........................................................................................................................................... 6 
2.3 
Risk/Benefit Assessment .................................................................................................................... 8 
2.3.1 
Known Potential Risks ..................................................................................................... 9 
2.3.2 
Known Potential Benefits .............................................................................................. 10 
2.3.3 
Assessment of Potential Risks and Benefits .............................................................. 10 
3 
OBJECTIVES AND ENDPOINTS .............................................................................................................. 11 
4 
STUDY DESIGN ........................................................................................................................................... 13 
4.1 
Overall Design .................................................................................................................................... 13 
4.2 
Scientific Rationale for Study Design.............................................................................................. 13 
4.3 
Justification for Intervention ............................................................................................................. 13 
4.4 
End-of-Study Definition ..................................................................................................................... 14 
5 
STUDY POPULATION ................................................................................................................................ 14 
5.1 
Inclusion Criteria ................................................................................................................................ 14 
5.2 
Exclusion Criteria ............................................................................................................................... 14 
5.3 
Lifestyle Considerations .................................................................................................................... 14 
5.4 
Screen Failures .................................................................................................................................. 15 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 15 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............................................ 16 
6.1 
Study Intervention(s) or Experimental Manipulation(s) Administration ...................................... 16 
6.1.1 
Study Intervention or Experimental Manipulation Description ................................. 16 
6.1.2 
Administration and/or Dosing ....................................................................................... 16 
6.2 
Fidelity ................................................................................................................................................. 17 
6.2.1 
Interventionist Training and Tracking .......................................................................... 17 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 18 
6.4 
Study Intervention/Experimental Manipulation Adherence.......................................................... 18 
6.5 
Concomitant Therapy ........................................................................................................................ 19 
6.5.1 
Rescue Therapy ............................................................................................................. 19 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................................................................... 19 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation ............................................. 19 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 20 
7.3 
Lost to Follow-Up ............................................................................................................................... 20 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 20 
8.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 21 
8.2 
Safety Assessments .......................................................................................................................... 22 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 22 
8.3.1 
Definition of Adverse Events ........................................................................................ 23 
8.3.2 
Definition of Serious Adverse Events .......................................................................... 23 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
8.3.3 
Classification of an Adverse Event .............................................................................. 23 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 24 
8.3.5 
Adverse Event Reporting .............................................................................................. 24 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 25 
8.3.7 
Reporting Events to Participants ................................................................................. 25 
8.3.8 
Events of Special Interest ............................................................................................. 25 
8.3.9 
Reporting of Pregnancy ................................................................................................ 25 
8.4 
Unanticipated Problems .................................................................................................................... 25 
8.4.1 
Definition of Unanticipated Problems .......................................................................... 25 
8.4.2 
Unanticipated Problems Reporting .............................................................................. 26 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................... 26 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 26 
9.1 
Statistical Hypotheses ....................................................................................................................... 26 
9.2 
Sample Size Determination .............................................................................................................. 27 
9.3 
Populations for Analyses .................................................................................................................. 28 
9.4 
Statistical Analyses............................................................................................................................ 28 
9.4.1 
General Approach .......................................................................................................... 28 
9.4.2 
Analysis of the Primary Endpoint(s) ............................................................................ 28 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 29 
9.4.4 
Safety Analyses .............................................................................................................. 29 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 29 
9.4.6 
Planned Interim Analyses ............................................................................................. 29 
9.4.7 
Sub-Group Analyses ..................................................................................................... 29 
9.4.8 
Tabulation of Individual Participant Data .................................................................... 29 
9.4.9 
Exploratory Analyses ..................................................................................................... 29 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 30 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 30 
10.1.1 
Informed Consent Process ........................................................................................... 30 
10.1.2 
Study Discontinuation and Closure ............................................................................. 31 
10.1.3 
Confidentiality and Privacy ........................................................................................... 31 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 32 
10.1.5 
Key Roles and Study Governance .............................................................................. 32 
10.1.6 
Safety Oversight ............................................................................................................. 33 
10.1.7 
Clinical Monitoring .......................................................................................................... 33 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 33 
10.1.9 
Data Handling and Record Keeping ............................................................................ 33 
10.1.10 
Protocol Deviations ........................................................................................................ 34 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 34 
10.1.12 
Conflict of Interest Policy .............................................................................................. 35 
10.2 
Additional Considerations ................................................................................................................. 35 
10.3 
Abbreviations and Special Terms ................................................................................................... 35 
10.4 
Protocol Amendment History ........................................................................................................... 37 
11 
REFERENCES ............................................................................................................................................. 37 
 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
STATEMENT OF COMPLIANCE 
 
(1) [The trial will be carried out in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form(s) must be obtained before any participant is consented. Any amendment to the protocol 
will require review and approval by the IRB before the changes are implemented to the study. All 
changes to the consent form(s) will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form.] 
 
 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date: 
10/2/2025 
 
Name*:  Samantha Leaf 
 
Title*: Senior Research Scientist 
 
Investigator Contact Information 
Affiliation*: ISA Associates, Inc. 
Address: 4501 Fairfax Drive, Ste 601 Arlington VA, 22203 
Telephone: 703-739-0880 
Email: sleaf@isagroup.com 
 
 
 
 
 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title:
Reducing Colorectal Cancer Health Disparities: An mHealth Intervention 
to Improve Screening among African American Men 
Grant Number:
R44CA246899
Study Description:
Two-arm, parallel-group randomized controlled trial comparing a 
tailored, SMS-delivered mobile education program with attention-
control (CDC video links) to improve completion of any guideline-
concordant colorectal cancer (CRC) screening by ~6 months among 
Black/African American men who are non-adherent to CRC screening. 
Objectives*:
 
Objectives: Primary—evaluate effect on completion of any guideline-
concordant CRC screening since enrollment. Secondary—evaluate 
effects on CRC beliefs (severity, susceptibility, benefits/barriers), 
knowledge, self-efficacy, and medical trust. 
Endpoints*:
Endpoints: Primary—binary indicator of any CRC screening since 
enrollment assessed at follow-up. Secondary—validated scale scores at 
baseline and follow-up. 
Study Population:
Black/African American men who are aged 45–75, non-adherent to CRC 
screening, and smartphone owners in Washington, DC 
Phase* or Stage:
Phase II clinical trial
Description of 
Sites/Facilities Enrolling 
Participants: 
Single U.S. community health center in Washington, DC
Description of Study 
Intervention/Experimental 
Manipulation: 
The study intervention includes a structured series of text messages 
that deliver links to brief, mobile-friendly videos on colorectal cancer 
risk, guideline-recommended screening options (FIT/FOBT, FIT-DNA, 
colonoscopy, CT colonography, and flexible sigmoidoscopy), and 
strategies to overcome common barriers. Messages are automated and 
paced over approximately 6–9 weeks, resulting in an estimated total 
exposure of about two hours of content. Comparator: CDC-developed 
CRC education links delivered by SMS and paced over 6 weeks. 
Estimated video length is 30–40 minutes total. 
Study Duration*:
18 months
Participant Duration:
6 months
1.2 
SCHEMA  
 
 
 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
Flow Diagram 
 
Pre-Screening 
 
 
 
 
 
 
 
 
Appointment 1 
       Day 1 
 
 
 
 
 
 
 
 
 
 
 
 
Appointment 2 
   Day ~180 
 
 
Total N: 128 
Participants who were due for a colorectal screening were contacted by our partner clinic  
and provided information on the study.  
Conduct informed consent process. Perform baseline assessments. See Section 1.3, 
Schedule of Activities 
Final Assessments 
See Section 1.3, Schedule of 
Activities 
Arm 1 (experimental)
N = 63 
Mobile SMS+video CRC 
education intervention 
Randomize
Arm 2 (control)
N = 65 
CDC-developed CRC videos 
via SMS links  
Potential participants who contact the study team are screened for eligibility by inclusion 
and exclusion criteria; schedule Appointment 1. 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
1.3 
SCHEDULE OF ACTIVITIES  
 
The schedule below is provided as an example and should be modified or replaced as appropriate.   
 
 
 
 
 
 
Pre-screening 
(Pre-consent) 
 
Appointment 1 
Day 1 
Day 2-60 
Day 61-180 
Appointment 2 
 Day  ~180 
EHR Review Eligibility 
X 
 
 
Study information sent to 
potential participants 
X 
 
 
Confirmatory eligibility 
screening 
X 
 
 
Informed Consent 
 
X 
 
 
Demographics 
 
X 
 
 
Outcome Evaluation 
 
 
 
 
Receipt of guideline-
concordant CRC screening
 
X 
 
X
CRC severity scale
 
X
 
X
CRC susceptibility scale
 
X
 
X
Colonoscopy 
benefits/barriers scale
 
X
 
X
Stool test benefits/barriers 
scales
 
X
 
X
CRC Knowledge 
questionnaire
 
X
 
X
Self-efficacy scale
 
X
 
X
Medical trust scale
 
X 
 
X
EHR Record Review
 
 
 
X
Randomization 
 
X 
 
 
Control Intervention  
 
 
X
X 
 
Experimental Intervention 
 
 
X
 
 
Adverse Events Reporting 
 
X 
X 
X 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
2 
 
INTRODUCTION 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
The following subsections should include relevant background information and rationale for the clinical 
trial. This should be a brief overview (e.g., approximately 3-7 pages). Referring to relevant intervention 
manuals for more detail is appropriate. Text for Sections 2.1 and 2.2 may come from the Background and 
Significance section of the grant application. 
 
2.1 
STUDY RATIONALE  
Colorectal cancer (CRC), the second overall leading cause of cancer death, is particularly 
burdensome for African American men, who have high incidence of the disease with lower survival rates 
at all CRC stages. 
Screening (e.g., colonoscopy, stool-based tests) can prevent most cases of invasive CRC. However, 
uptake is inadequate, especially among low SES African American men. Most efforts to increase CRC 
screening in this group utilize in-person or telephone-based education and navigation. While effective, 
these approaches are resource intensive, limiting their adoption by organizations that serve low SES 
Black men, such as Federally Qualified Health Centers (FQHCs).   
To address the need for an effective, affordable, and scalable strategy to increase CRC screening 
among African American men, this project developed a mobile colorectal cancer screening intervention 
(m-CRCSI) for this group. m-CRCSI is based on the health belief model (HBM) and delivered via mobile 
phone. It includes text messages designed to improve CRC knowledge and health beliefs. Some text 
messages include links to videos, including educational instruction and unscripted peer narratives. 
Program content is designed to reduce health literacy barriers and promote CRC screening adherence.  
A prototype m-CRCSi was developed in Phase I. This development was informed by formative 
research with community-based care providers and target end-users. The results of Phase I far exceeded 
the proposed benchmarks and strongly support the usability, acceptability, and potential effectiveness 
of the intervention.  
During Phase II we completed development of the m-CRCSi. Then, in collaboration with Family and 
Medical Counseling Service (our partner FQHC), we examined the effectiveness of the m-CRCSi to 
increase CRC screening in African American men. Participants were randomly assigned to either the 
intervention condition or to a matched control condition. Secondary measures assessed health beliefs, 
trust in the medical system, and knowledge. 
 
2.2 
BACKGROUND  
CRC Screening Saves Lives 
Most CRCs develop from precancerous polyps. Because these polyps grow slowly, early detection 
and removal can prevent the majority of cases from becoming invasive cancer.2,9,10 For average risk 
adults, the US Preventive Services Task Force (USPSTF) recommends regular screening between 50 and 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
75.33 Several tests are approved to detect CRC or precancerous polyps. The “gold standard” is 
colonoscopy, a direct visualization of the colon and rectum.2 This is the only procedure that allows for 
simultaneous detection and removal of polyps throughout the entire colon and rectum. It also requires 
retesting only every 10 years.2,34 Despite these advantages, significant barriers associated with 
colonoscopy include availability, cost, transportation, and the need to fully cleanse the colon with 
laxatives prior to testing.2 As a result, stool-based screening methods, like the guaiac fecal occult blood 
test (gFOBT) and fecal immunochemical test (FIT), are popular alternatives.2,35,36 Both detect blood from 
CRC in stool but require annual rescreening. A newer fecal test, FIT-DNA, can detect either blood or 
genetic mutations shed by CRC and polyps and is recommended every 1-3 years.2 Irrespective of which 
fecal test is performed, any positive result should be followed by colonoscopy.2 Ultimately, most medical 
and research professionals agree that “the best test is the one that gets done.”37  
CRC Screening in African American Men 
Unfortunately, adherence to any of these CRC screening options is far too low. This is especially true 
among men, particularly those who are younger and low SES.38,39 Given this, it is not surprising that 
screening compliance is particularly poor among low SES African American men.2,11  
Socioeconomic disadvantage in the United States is associated with lower colorectal cancer 
screening rates.12-15 Contributing factors include inconsistent health insurance,40,41 out-of-pocket costs 
for CRC screening tests,40,42 and few interactions with primary care.43 In clinical settings, some patients 
report receiving less comprehensive counseling about screening and fewer screening 
recommendations,40,41,44 as well as feeling unheard or treated impersonally.45 Clinicians may also be less 
aware of practical barriers faced by patients with fewer resources46,47 and expectations about patient 
dependence or follow-through can vary by socioeconomic context.48 
In addition to institutional and provider-level concerns, many individuals with fewer socioeconomic 
resources face substantial cognitive and emotional challenges to colorectal cancer (CRC) screening. Lack 
of trust in the medical system, encompassing concerns about fairness in care and discomfort in clinical 
settings, is commonly reported,41,46,49-53 particularly among lower-SES populations.54 In addition, Black 
men and low income patients typically have lower health literacy (i.e., difficulty understanding health 
information to make health decisions) 25,55,56 and limited CRC knowledge.41,55,57 Finally, underestimation 
of personal CRC risk and confusion about available screening options (e.g., believing that a digital rectal 
exam screens for CRC) are frequent and can depress screening uptake.64-67  
Increasing CRC Prevention Efforts Among Low SES African American Men 
 
The Community Preventive Services Task Force (CPSTF) recommends patient education to increase 
CRC screening rates.68 Indeed, studies show that educational approaches, especially when culturally-
targeted, improve screening rates among low SES African Americans.58,69-71 Many of these initiatives 
involve in-person or phone-based education from nurses, health educators, or community health 
workers (CHWs). For example, Menon and colleagues developed a tailored, telephone-based 
intervention that focused on improving CRC knowledge and reducing screening barriers. Among a 
primarily male, unemployed African American sample, receipt of these counseling calls by health 
educators led to higher rates of CRC screening compared to usual care.72 Similarly, CHW-delivered group 
education among a sample of mostly publicly-insured African Americans increased screening at 6-month 
follow-up relative to controls.73  

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
 
Another common approach to delivering CRC education is through patient navigation (PN). Patient 
navigators are trained professionals who provide personalized education and assist with scheduling and 
completing cancer-related medical appointments. Research demonstrates that PN increases CRC 
screening adherence among low SES African American men.74-77 Unfortunately, PN and other in-person 
educational interventions are costly and resource intensive.69,78-80 Further, PN services are typically not 
reimbursable by insurance providers, requiring health care organizations to absorb their expense.69,79,80 
Until the return on investment of these services is established, these approaches will continue to have 
poor uptake.74,81-84 
 
In particular, resource- and cost-intensive interventions are unlikely to be practicable for health care 
organizations that serve low SES African American men, such as Federally Qualified Health Centers 
(FQHCs). FQHCs are community-based organizations that provide health care services regardless of an 
ability to pay. There are nearly 1,400 FQHCs operating 12,000 service delivery sites in all 50 states plus 
the District of Columbia. These health centers serve almost 30 million patients each year.85 In 2019, only 
45% of eligible patients seen in FQHCs were adherent to CRC screening.85 Researchers have suggested 
that implementing effective interventions at FQHCs may be particularly impactful on CRC incidence and 
mortality, given the role these centers play in serving low SES and underinsured populations.58 Indeed, 
the CDC’s Colorectal Cancer Control Program was created to increase CRC screening rates among these 
populations by funding cost-effective, evidence-based interventions in FQHCs and similar health care 
systems.86 
 
To address the need for an effective, affordable, and scalable intervention to increase CRC screening 
among African American men, we developed m-CRCSi: a theory-based, tailored mobile CRC screening 
intervention for this group. The Health Belief Model (HBM), a widely used theoretical framework for 
understanding health behavior, guided development.26,87 The HBM successfully predicts African 
American men’s CRC screening.72 More importantly, interventions based on this model significantly 
increased CRC screening rates among low-income African Americans.88 The HBM posits that a person is 
more likely to perform a health behavior when he: understands the seriousness of an illness (perceived 
severity) and feels there is a realistic chance he will develop it (perceived susceptibility), expects the 
health behavior will reduce risk of illness (perceived benefits) with relatively few costs (perceived 
barriers), is aware of the health behavior (cues to action), and believes he can perform it (self-efficacy).26 
Theory-based assessments of these health beliefs were used to tailor m-CRCSi. Moreover, the program 
contextualized HBM constructs consistent with the particular health beliefs and information needs of 
low SES African American men30,31 and integrated congruent imagery, language, and values.31 
Interventions targeted in this way are rated more positively, perceived as more credible, and lead to 
greater adherence to health behavior recommendations than generic interventions.89-91 
 
2.3 
RISK/BENEFIT ASSESSMENT  
 
The following subsections should include a discussion of known risks and benefits, if any, to human 
participants. Text from the corresponding sections of the Human Subjects section of the grant application, 
and/or IRB package may be used here.  

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
 
2.3.1 KNOWN POTENTIAL RISKS  
This behavioral study (surveys plus SMS-linked educational materials) is minimal risk. No drugs, devices, 
or invasive procedures are involved; therefore package inserts or an Investigator’s Brochure are not 
applicable. Risks align with published literature on health communication and mobile health interventions 
and fall into psychological and privacy domains, with negligible physical, social, legal, or economic risk. 
We believe that the potential risks of collecting the survey data are small. It is possible that as a result of 
completing the research survey questions, a participant may learn that he is at risk for CRC. This realization 
may be accompanied by distress.  If this should occur during the survey administration, participants will 
be encouraged to discuss their concerns with FMCS staff, who are trained to address these issues and to 
provide medical and psychological treatment as needed. They will also be provided with a list of resources 
in the informed consent that can provide information about CRC and recommended screening tests. To 
minimize this risk, participants will be completing their surveys on the computer. Their names will not be 
associated with their responses. In addition, the questions will be phrased in ways to minimize any 
potential discomfort and participants will be free to skip any question they do not wish to answer. Finally, 
the research team is using survey items that have been successfully used in past research with similar 
populations.    
While the m-CRCSi includes sensitive information about CRC and one’s risk for developing it, it is only 
accessible on a participant’s personal mobile phone. Before engaging with the intervention, all 
participants will be educated in mobile phone security best practices, including password-protecting one’s 
phone, erasing sensitive text messages, and turning off message preview functionality (i.e., so that text 
message content is not previewed on the phone’s lock screen). In addition, all participants must opt-in to 
receiving intervention messages by sending a text message to a study-provided number. Participants will 
be told that they may choose to opt-out of the intervention and messages at any time. Further, our strict 
security strategy will include transmitting data to participants from a secure server, which reads telephone 
numbers and then transmits data to a personal phone through a secure communication protocol HTTPS 
to a SMS text messaging gateway. HTTPS will provide authentication of the third-party SMS text messaging 
service that the program will use to transmit the text messages, ensuring that no data (e.g., phone 
numbers) are intercepted by a third party. In addition, all assessment items completed by experimental 
group participants will be encrypted in the program database, the program database will be hosted on a 
separate server from the web application, and the hosting servers will be behind a web application 
firewall. Access to content on the mobile webpages will require authentication and the text-based active 
links to web content will be set to expire after a set time or number of access attempts.  
We believe that the potential risks of going through either the experimental or control conditions is small. 
It is possible that, as a result of reviewing either the m-CRCSi or control materials, a participant may learn 
that he may have put himself at risk of developing CRC by not being screened. These realizations may be 
accompanied by distress. If this should occur, participants will be encouraged to discuss their concerns 
with FMCS staff, who are trained to address these issues and to provide medical and psychological 
treatment as needed. The informed consent will also provide information on alternative methods for 
receiving the type of information available in the m-CRCSi and control materials. 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
2.3.2 KNOWN POTENTIAL BENEFITS  
Include a discussion of known potential benefits from either clinical or nonclinical studies. For behavioral 
or social intervention studies, relevant published literature should provide relevant benefits information. 
For studies including a licensed or approved product, a package insert or device labeling should be used as 
a primary source of benefits information. If the study includes an investigational product, the Investigator’s 
Brochure (IB) should be a primary source of the benefits information.  
 
Describe any physical, psychological, social, legal, or any other potential benefits to individual participants 
or society in general, as a result of participating in the study, addressing each of the following:  
 
• 
Immediate potential benefits 
• 
Long-term potential benefits 
 
Note that payment to participants, whether as a non-coercive inducement to participate or as 
compensation for time and inconvenience, is not considered a “benefit.” Provision of incidental care is also 
not to be considered a benefit. For details of compensation see Section 5.5, Strategies for Recruitment 
and Retention. 
 
There are several benefits to participating in the proposed research to both the research participants and 
others. The first is the development of a state-of-the-art mobile intervention that can provide participants 
with valuable tailored information about CRC, the CRC screening tests that are available, the benefits of 
screening, and how to overcome barriers to screening. m-CRCSi is designed to improve CRC knowledge 
and health beliefs, with the ultimate goal of increasing CRC screening and reducing health disparities. 
Because the intervention is mobile, the information can be accessed at a time and place of the user’s 
choosing. This information should not only be of interest to participants but also help them understand 
the CRC screening tests that are available to them and the value of being screened. This research also has 
the potential to benefit many other African American men, as ISA will use participant input to make 
changes in the design of the m-CRCSi to better meet the needs of the larger community of African 
American men. Given that the potential risks are very small, the risk to participants seems quite 
reasonable in relation to the benefits. 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
Include an assessment of known potential risks and benefits, addressing each of the following: 
• 
Rationale for the necessity of exposing participants to risks 
• 
A summary of the ways that risks to participants were minimized in the study design 
• 
Justification as to why the value of the information to be gained outweighs the risks of 
participation in the study  
 
As indicated above, the risks to study participants are small. ISA will protect against any potential risk and 
ensure the confidentiality of the data using multiple methods. First, to protect against psychological risk 
or discomfort in completing the survey, participants will be informed of the confidentiality of the surveys 
(i.e., they will contain no personally identifying information) and the secure nature of the computer-based 
survey tool. In addition, questions will be phrased in a way to minimize discomfort and participants will 
be free to skip questions they do not wish to answer. No one outside the study team will have access to 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
the data. Moreover, participants will be told specifically that if, because of reviewing their assigned 
materials or completing the research surveys, they are feeling distressed about their physical health, they 
should discuss their concerns with an FMCS staff member. They will also be provided with a list of 
resources in the informed consent that can provide information about CRC and screening.  
 
To maintain confidentiality of all data collected, no names or other identifying information will be included 
with the recorded MRR screening data, on the survey, or as part of m-CRCSi or the control materials. As 
noted earlier, the file that will link the participant name to the user ID and study phone number will be 
maintained on a password protected computer that will not house the survey data. The only people that 
will have access to the linking file will be the Principal Investigator and her staff. Finally, we will utilize 
strict security protocols – described previously – to protect the confidentiality of all information 
transmitted via SMS and stored on our secure server as part of the m-CRCSi intervention.  
 
To protect against any breaches of confidentiality, all project staff proposed to conduct the data collection 
have received or will receive training on the protection of research participants and are or will be well 
versed in the Code of Federal Regulations (including 45 CFR 46 and 42 CFR) and the Belmont Report. ISA 
continually obtains information from the Office for Human Research Protections (OHRP) at NIH on new 
regulations regarding the protection of human subjects, which is disseminated to all staff. Further, 
participants will have the MRR procedure explained to them and will be asked to complete a medical 
release form before any medical records are extracted. In addition, any ISA staff proposed to work on the 
MRR and EHR extraction are or will be trained in all applicable HIPAA regulations. 
 
After all participants have completed follow-up surveys, the linking file housed on the ISA computer – the 
only file that contains participant’s personal information (e.g., name, phone number) – will be deleted. In 
addition, the Windows Eraser program will be used to completely remove (i.e., “wipe”) the linking file 
from the computer by overwriting it several times using government-sanctioned deletion algorithms.  
Deidentified participant research data from the baseline and follow-up surveys will be retained for 3 years 
from the submission of the final financial report to NIH, in keeping with guidelines described in the NIH 
Grants Policy Statement. 
 
The Phase II evaluation will provide very important information about the efficacy of the m-CRCSi to 
improve health beliefs and increase completion of recommended CRC screening tests among low SES 
African American men. This data is critical to developing a successful program that can help men prevent 
CRC or find it early when treatment is most successful. Knowledge gained from this field test will be 
integrated into the final program prior to marketing to FQHCs and other health care organizations. We 
believe that the risks associated with this Phase II effort are reasonable in relation to the valuable 
information we will receive. 
3 
OBJECTIVES AND ENDPOINTS  
Provide a description of the study objectives and endpoints, as well as a justification for selecting the 
particular endpoints, in the table format included below. This will provide clear articulation of how the 
selected primary and secondary endpoint(s) are linked to achieving the primary and secondary objectives 
and an explanation of why endpoint(s) were chosen. Data points collected in the study should support an 
objective or have a regulatory purpose. Therefore, careful consideration should be given prospectively to 
the amount of data needed to support the study’s objectives. 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
 
An objective is the purpose for performing the study in terms of the scientific question to be answered. 
Express each objective as a statement of purpose (e.g., to assess, to determine, to compare, to evaluate) 
and include the general purpose (e.g., feasibility, acceptability, engagement of the intervention target, 
identifying mechanisms of action, mediation, moderation, efficacy, effectiveness, dissemination, 
implementation). 
 
A study endpoint is a specific measurement or observation to assess the effect of the study intervention. 
Study endpoints should be prioritized and should correspond to the study objectives and hypotheses being 
tested. Give succinct and precise definitions of the study endpoints used to address the study’s primary 
objective and secondary objectives (e.g., specific diagnostic tests that define safety or efficacy, clinical 
assessments of disease status, assessments of psychosocial characteristics, patient reported outcomes, 
behaviors or health outcomes). A full description of study endpoints, including administration, scoring, 
psychometrics, adjudication of endpoints, etc., belongs in Section 8, Study Assessments and Procedures.   
 
A putative mechanism of action is the theorized explanation for how the intervention functions.   
 
Consider whether primary and secondary endpoints should be adjusted for multiple comparisons, family-
wise error rates, alpha inflation, etc. Details of any such adjustments should be included in Section 9.4.2, 
Analysis of the Primary Endpoint(s) and Section 9.4.3, Analysis of the Secondary Endpoint(s).   
 
OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR 
ENDPOINTS 
Primary
To evaluate whether the 
intervention increases CRC 
screening in noncompliant African 
American men. 
 
 
 
Medical Records Review 
verification of colorectal 
cancer screening since 
study entry 
 
Self-report of CRC 
screening since study 
entry 
 
Tests causal mechanism  
Secondary
To evaluate whether the 
intervention improves health beliefs 
and knowledge in noncompliant 
African American men. 
 
 
Perceived severity of CRC 
 
Perceived susceptibility to 
CRC 
 
Perceived barriers to 
colonoscopy and stool 
tests 
 
Perceived benefits of 
colonoscopy and stool 
tests 
 
Trust in the medical 
system 
Tests causal mechanism or 
potential moderating effects 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR 
ENDPOINTS 
 
CRC knowledge 
 
4 
STUDY DESIGN 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
4.1 
OVERALL DESIGN 
 
This is a Phase II single-site randomized, 2-arm between-subjects study examining differences in CRC 
screening and related beliefs between participants randomized to the experimental intervention and 
those randomized to the attention control condition (text messages providing CRC information and links 
to CDC-developed videos). Outcomes were assessed at baseline and again at 6-months post-baseline. We 
hypothesized that experimental participants would be more likely to get screened for CRC and report 
more positive beliefs about screening than control participants. Participants were assigned to conditions 
by an algorithm programmed into the study computer using a permuted blocks randomization scheme. 
Blocks of size 4 and 6 were used. Assignments within blocks was be random but balanced among the two 
conditions and the order of the blocks (4 vs 6) also was random. This procedure will ensure that the 
number of participants randomized to each condition was equal, that any imbalance among the 
conditions at any point during the recruitment and randomization was modest, and that it would be very 
difficult to guess the assignment of the next participant. Randomization was administered via computer-
based admin system and triggered by the study coordinator.   
 
The intervention – m-CRCSi – combines text messages with brief educational and motivational videos to 
provide CRC education, reduce screening barriers, and promote timely screening.  
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
Participants in the control condition received a text explaining that over the next several weeks they 
would be receiving information about CRC developed by the CDC. Over the next 8 weeks, users receive 
16 text messages with either information about CRC or links to CDC-developed videos about CRC. These 
texts and videos include information about CRC, CRC screening tests, barriers and benefits to CRC 
screening, and other health-related beliefs about CRC. This control condition was chosen to provide a 
close match to the content, format, and delivery schedule of the experimental intervention. This study 
design was chosen to allow for a comparison between the m-CRCSi intervention and widely available 
video-based content developed by the leading public health agency protecting the health of Americans.  
 
4.3 
JUSTIFICATION FOR INTERVENTION 
 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
m-CRCSi is an effective, affordable, and scalable intervention to increase CRC screening among African 
American men. The intervention is based on the Health Belief Model (HBM). The HBM posits that a person 
is more likely to perform a health behavior when he: understands the seriousness of an illness (perceived 
severity) and feels there is a realistic chance he will develop it (perceived susceptibility), expects that the 
health behavior will reduce risks from the illness (perceived benefits) with relatively few costs (perceived 
barriers), is aware of the health behavior (cues to action), and believes he can perform it (self-efficacy). 
The intervention integrates text messages and videos because the majority of African American men own 
and use smartphones. Delivered across 5 “chapters,” the videos are designed to address potential health 
literacy concerns by providing brief and clear information about CRC and screening options. It is expected 
that men will engage with all intervention content.  
 
4.4 
END-OF-STUDY DEFINITION 
 
A participant is considered to have completed the study if he or she has completed the baseline 
assessment and the 6-month follow-up assessment. 
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Provision of signed and dated informed consent form 
2. Stated willingness to comply with all study procedures and lifestyle considerations and 
availability for the duration of the study  
3. Males; ages 45-75 
4. Self-identify as Black or African American 
5. Noncompliant with CRC screening recommendations via medical records review 
6. Access to a smartphone 
 
5.2 
EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this study: 
 
1. Lack of limited English literacy skills 
2. Presence of colorectal cancer or a previous colorectal cancer diagnosis 
5.3 
LIFESTYLE CONSIDERATIONS 
 
N/A 
 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
5.4 
SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or entered in the study. Re-screening is permitted if 
circumstances change.  
 
 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Participants will be recruited by 2-3 community health workers employed by our partner medical 
clinic. The partner clinic serves Washington, DC communities east of the Anacostia River and are an 
integral part of the community with extensive outreach efforts including a needle exchange mobile 
van program and oral rapid HIV testing at DMV sites. Based on the clinic’s wide range of services, it is 
likely that participants’ health status will range from those who are healthy to those who are 
managing one or more chronic diseases or infections (e.g., Hepatitis C, diabetes, hypertension). 
Recruitment will occur at the partner clinic and in the surrounding community where outreach 
activities are conducted. Specifically, 2-3 community health workers will hand out palm cards to 
African American men in the primary care waiting rooms and at community outreach events (e.g., 
health fairs). The recruiters, as well as the text on the palm card, will instruct interested participants 
to contact the onsite field test coordinator for more information about the project and will provide 
the room number, a telephone number, and the hours during which the field test coordinator is 
available. We successfully used this strategy to recruit African American men from the same clinic for 
a recent randomized trial of a computer-based HIV behavioral intervention. 
 
To maximize retention, this study will employ several techniques that have proven successful in 
previous research projects conducted at the clinic with similar populations. First, the onsite field test 
coordinator will collect as much contact information as the participant feels comfortable providing 
(e.g., additional phone numbers, email address, preference for calls v. text messages). This will include 
asking about secondary contacts – these are alternate phone numbers where the participant can be 
reached, such as the number of a parent, spouse, or friend. To protect participant’s privacy, the field 
test coordinator will record how the project should be identified when calling each secondary contact 
(e.g., “the colorectal cancer project” v. “the phone study”). We have successfully retained participants 
whose personal phones were temporarily unavailable (e.g., the phone was broken or disconnected, 
the participant got a new number) using this strategy. Second, we will offer reminder texts or calls the 
day before a scheduled appointment. Third, if a participant misses a scheduled appointment, the field 
test coordinator will implement the retention protocol with the goal of rescheduling the missed 
appointment. Specifically, the field test coordinator will contact the participant via his preferred 
contact method the day of the missed appointment and – if he is not reached – every two business 
days thereafter for one week. If the participant is not reached within a week, the ISA field test 
coordinator will begin calling the alternate contacts’ phone numbers. If the participant is not reached 
after calling each alternate contact once, the field test coordinator will continue contacting the 
primary number every two days for an additional week. If the participant is not reached after two 
weeks, the field test coordinator and the Principal Investigator will meet to determine whether 
additional contacts are warranted or if the participant should be categorized as “lost to follow up.” 
 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
In general, retention rates for projects conducted at the clinic have been high. The clinic is well 
regarded in the community and many participants visit regularly for medical care or other services. 
We believe the proposed study will have similarly favorable retention rates. 
 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
No text is to be entered in this section; rather it should be included under the relevant subheadings below.   
 
6.1 STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
No text is to be entered in this section; rather it should be included under the relevant subheadings below.   
 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
 
m-CRCSi is an effective, affordable, and scalable intervention to increase CRC screening among African 
American men. The Health Belief Model (HBM) will guide intervention development. The HBM posits that 
a person is more likely to perform a health behavior when he: understands the seriousness of an illness 
(perceived severity) and feels there is a realistic chance he will develop it (perceived susceptibility), 
expects that the health behavior will reduce risks from the illness (perceived benefits) with relatively few 
costs (perceived barriers), is aware of the health behavior (cues to action), and believes he can perform it 
(self-efficacy). Theory-based assessments of these health beliefs will be used to tailor the intervention. It 
will also be targeted by contextualizing HBM constructs with the health beliefs and information needs of 
African American men and by integrating congruent imagery, language, and values. 
 
Participants meet “William,” a Black health educator, who hosts five short video chapters: CRC basics; 
personalized screening guidance; colonoscopy deep-dive; stool-test options; and real-world roadblocks 
(cost, access, distrust, logistics) with practical workarounds. Content mixes host segments, expert Q&A 
(Dr. Malcolm), and men’s roundtables to normalize screening, name fears, and model solutions. After 
Chapter 1, a brief health history routes men to tailored messages: average-risk vs high-risk; unscreened 
vs up-to-date; under-45 paths; symptom prompts. Chapter 2 scripts change accordingly, then branch into 
colonoscopy vs stool-test education with concrete prep tips, tradeoffs, and “which test fits you” framing. 
A participant learns the basics, receives a personalized plan, selects a test that fits, uses reminders and 
resources to overcome barriers, and confirms screening via “SCREEN”—all with minimal clinic lift and high 
resonance. 
 
Attention-control materials consist of a series of text messages including information and links to CDC-
produced videos covering CRC risk, screening options, and general prevention. Over 8 weeks, users receive 
16 text messages with either information about CRC or links to CDC-developed videos about CRC. These 
texts and videos include information about CRC, CRC screening tests, barriers and benefits to CRC 
screening, and other health-related beliefs about CRC.  
6.1.2 ADMINISTRATION AND/OR DOSING 
 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
Participants in the intervention arm receive a fully automated, mobile program that blends short, pre-
recorded video chapters with behaviorally informed SMS prompts. Delivery is remote and device-based 
(links arrive by text; videos open on the participant’s phone), so all exposure occurs in participants’ 
everyday settings rather than in clinic (video host “William,” a health educator, introduces and guides the 
experience). The curriculum phase consists of a sequenced video pathway with five content areas: (0) 
Orientation/how-to; (1) CRC basics and screening rationale; (2) a tailored “Your Screening Plan”; (3) 
colonoscopy skills/support; and (4) stool-test skills/support, followed by (5) “Roadblocks” with practical 
workarounds. This structure (multiple brief videos per chapter) is scripted and enumerated in the master 
outline. A complete (“full-dose”) curriculum exposure is defined as viewing the core chapter set (0–5) with 
the tailored branch in Chapter 2 (average- vs high-risk; screened vs unscreened) and the colonoscopy 
and/or stool-test micro-modules appropriate to that branch. Immediately after education, participants 
enter a Post-Education Screening Assistance (PESA) phase driven by SMS logic. This phase checks status, 
offers tips/resources, and schedules periodic reminders keyed to whether a colonoscopy or stool test is 
planned, scheduled, completed, or not planned. Example schedules include check-ins and supports at 2, 
3, 5, 6, 8, 10, 12, 14 days and beyond, with the system extending supportive messaging out to roughly 16 
weeks (e.g., 88, 94, 100, 108, and 116 days since the initial PESA trigger). 
 
Curriculum frequency/intensity. Videos are brief (micro-learning format) and delivered via SMS links in 
sequence; the program advances if a user stalls, with nudges to keep momentum. The curriculum 
comprises multiple short videos across Chapters 0–5; for dose accounting, we treat each chapter as a 
“session,” yielding ~5 sessions for a full curriculum dose (with additional sub-sessions in the tailored 
Chapter 2 branch and the chosen test-skills modules).  
PESA frequency/intensity. After education, SMS prompts occur on a fixed timer and/or when users report 
milestones (e.g., “scheduled in 2–4 weeks,” “don’t know date yet,” “planning to schedule”). Messages 
cluster early (2–10 days), then taper while extending for up to ~116 days if screening has not yet occurred.  
Engagement prompts and escalations. If the post-education questionnaire is not completed within 5 
days, targeted nudges are sent to re-engage and route the appropriate support stream.  
 
There are no live interventionists and no participant-to-participant interaction after randomization. All 
contact is one-to-one, automated, and virtual: a pre-recorded health educator hosts the videos; the SMS 
engine personalizes cadence and content based on responses (e.g., keywords such as SCREEN) and 
branching logic. No face-to-face or group sessions are conducted. 
 
Control arm receives 1–2 SMS per week for 8 weeks providing information about CRC and linking to CDC 
materials. 
 
6.2 
FIDELITY 
No text is to be entered in this section; rather it should be included under the relevant subheadings below.  
This section refers to efforts made to confirm that the intervention is appropriately conducted by the 
interventionist(s).  It is distinct from the content of Section 6.4, Study Intervention Adherence, which is 
intended to capture a study participant’s adherence to an intervention. 
 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
 
Timed text messages – called nudges – are sent to experimental participants at pre-specified intervals if 
they have not engaged with or completed a video chapter. After 7 days, an autodrop of the next chapter 
is triggered even if participants have not completed the previous chapter. Although no one “administers” 
the intervention content, study staff may assist with enrollment logistics and basic tech support. Staff will 
not advise on screening choices or alter message timing/content. If a participant becomes “stalled” (i.e., 
they have not engaged with intervention content in over 7 days and have not completed the intervention), 
an email message is sent to the study coordinator. The study coordinator then contacts the participant to 
inquire about any issues or questions and reinforce the importance of engaging with the intervention.  
 
To ensure consistent delivery across arms, we will perform routine quality control (QC) checks using the 
SMS platform’s audit logs and dashboards. QC procedures include: (a) automated monitoring of send 
failures (hard/soft bounces) with daily review and same-day re-send or number verification; (b) timing-
drift checks comparing scheduled vs. actual send times (tolerance ±5 minutes for fixed-time sends; ±24 
hours for week-based sequences) with corrective action logged; (c) weekly link-uptime validation (HTTP 
status and redirect integrity) for all URLs in both arms, with broken links replaced from a preapproved list; 
and (d) parity audits to confirm equivalent contact frequency and timing windows across study arms. All 
QC activities are documented in an audit trail (issue, detection date, corrective action, verification). 
Responsibility: Study Technologist (daily automated checks) and Project Manager (weekly parity audit); 
oversight by the PI. 
 
Control fidelity is tracked via delivery logs, weekly link checks, and audit reports confirming scheduled 
sends and link availability. 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
Participants will be assigned to conditions by an algorithm programmed into the computer-based research 
portal. Randomization will utilize a permuted-blocks randomization scheme. Blocks of size 4 and 6 will be 
used. Assignments within blocks will be random but balanced among the two conditions and the order of 
the blocks (4 vs 6) also will be random. This procedure will ensure that the number of participants 
randomized to each condition will be equal, that any imbalance among the conditions at any point during 
the recruitment and randomization will be modest, and that it will be very difficult to guess the assignment 
of the next participant. Because the intervention and control materials are inherently different, 
participants and research staff cannot be blinded to assignment. To limit bias, primary outcome 
ascertainment (MRR-verified receipt of CRC screening within 6 months) will be conducted by clinic staff 
who abstract electronic health records without reference to group assignment; two abstractors will 
review each record and reconcile discrepancies, providing an additional safeguard against bias. 
 
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
Participants’ adherence is tracked entirely through platform telemetry. During the curriculum phase, the 
SMS system records each linked video open and completion at the chapter/video level, issues time-based 
nudges when progress stalls (e.g., Day 2/4/6/7 rules for Chapter 1), and—if needed—auto-advances to 
the next assessment to preserve momentum. In the post-education phase, completion of the brief status 
questionnaire is monitored; automated reminders are sent at 2, 4, and 5 days if incomplete. Thereafter, 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
scheduled check-ins and resources continue on a fixed cadence (extending to ~116 days for 
noncompleters), and participant replies (including the keyword SCREEN) are logged as adherence signals 
and to close out the program when screening is reported. 
 
Mandatory activities to remain an active participant are: consent, baseline questionnaire completion, 
randomization, and provision of a working mobile number (to enable delivery). All subsequent educational 
exposures (video views) and assessments are encouraged and tracked but not required for continued 
participation; the system’s escalation (nudges/auto-drops) is designed to maximize exposure without 
removing participants for nonresponse.  
 
Source records for adherence include the SMS platform logs (timestamps, message types, 
opens/completions, replies) and assessment completion flags. Optional activities available to participants 
(and tracked when used) include engaging the built-in reminder system and revisiting resources/videos; 
use is captured by link launches and elapsed time triggers. 
 
No in-person visits are required for adherence. For transparency in reporting dose/exposure, we will 
summarize: number of curriculum videos delivered/opened, assessment completion and days-to-
completion, number of SMS messages delivered and proportion eliciting a reply, days retained in the 
assistance stream, and whether/when screening was confirmed via SMS. 
 
Control-arm adherence (e.g., link click-throughs or time on page) is not collected. To minimize participant 
burden and maintain parity with standard informational outreach, we verify delivery only, using SMS send 
logs. Primary analyses are intention-to-treat and do not rely on control exposure metrics. 
6.5 
CONCOMITANT THERAPY 
 
N/A 
 
6.5.1 RESCUE THERAPY 
 
N/A 
 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
When a subject discontinues from the intervention but not from the study, remaining study procedures 
will be completed as indicated by the study protocol.  If a clinically significant finding is identified 
(including, but not limited to changes from baseline) after enrollment, the investigator or qualified 
designee will determine if any change in participant management is needed. Any new clinically relevant 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
finding will be reported as an adverse event (AE). The data to be collected at the time of study intervention 
discontinuation will include the following: the reason(s) for discontinuing the participant from the 
intervention, and methods for determining the need to discontinue 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue a participant from the study for the following reasons: 
 
 
Lost-to-follow up; unable to contact subject  
 
Participant withdraws consent for further participation and/or data use. 
 
Participant texts “STOP” to the experimental intervention phone number. 
 
Safety concerns: any SAE or AE judged related to participation that warrants removal, per the 
Data and Safety Monitoring Plan and IRB reporting rules. 
 
Ineligibility discovered post-enrollment, duplicate enrollment, or other protocol violations that 
compromise data integrity. 
 
Investigator decision that continued participation poses undue burden or risk (e.g., credible 
threats of harm), consistent with IRB policies. 
 
The reason for participant discontinuation or withdrawal from the study will be recorded on a dedicated 
Case Report Form (CRF). Participants who withdraw or are discontinued after randomization will not be 
replaced; enrollment continues until the target sample size is reached. 
 
7.3 
LOST TO FOLLOW-UP 
 
A participant will be considered lost to follow-up if he or she fails to respond for the 6-month follow-up 
call and study staff are unable to contact the participant after at least 3 attempts.  
 
The following actions must be taken if a participant fails to respond for a required study appointment: 
 
 
The site will attempt to contact the participant, reschedule the missed baseline or follow-up 
appointment, counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain if the participant wishes to and/or should continue in the study 
 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls including to a 
secondary contact number). These contact attempts will be documented in the participant’s study 
file.  
 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
 
This individually randomized, remote trial evaluates a mobile, video+SMS colorectal cancer (CRC) 
screening education program versus a standard-materials control. All study activities are conducted 
virtually; no study-specific physical exams, imaging, or biospecimen collection occur. Outcome 
verification uses medical record review (MRR) and self-report. 
 
Screening, eligibility, and enrollment 
 
Eligibility confirmation window. Up to 30 days prior to enrollment. Site staff confirm basic 
eligibility from clinic records (e.g., age, overdue for CRC screening per guidelines, active phone 
number). 
 
Consent & MRR authorization. Participants complete electronic informed consent and provide 
HIPAA authorization for MRR. 
 
Baseline survey. Immediately post-consent, participants complete a baseline questionnaire. 
 
Randomization. After baseline completion, participants are assigned to intervention or control. 
Interventions begin (initial administration conditions) 
 
Intervention arm. Participants receive an SMS link to the curriculum hub and proceed through 
brief, pre-recorded videos with tailored branches, followed by a post-education screening 
assistance (PESA) text sequence. 
 
Control arm. Participants receive text messages, some with links to standard educational 
materials via SMS. A working mobile number and ability to receive texts are required for 
delivery; there are no in-person or group sessions. 
Measures and assessments (non-safety) 
Baseline (pre-randomization) 
 
Demographics and contact details (mobile number required for delivery). 
 
CRC screening history (ever screened; modality and timing if applicable). 
 
Psychosocial measures (e.g., CRC knowledge; perceived risk/severity; perceived 
benefits/barriers for stool tests and colonoscopy; medical trust; self-efficacy). 
During intervention (process/dose) 
 
Platform telemetry: timestamps for each SMS, link launches, chapter/video opens (percent 
viewed), assessment completions, participant replies (including keyword confirmations), and 
time in the assistance stream. These are used for exposure/dose summaries and adherence 
monitoring (not safety). 
Follow-up (primary outcome window) 
 
Primary outcome ascertainment: Receipt of any guideline-concordant CRC screening within 6 
months post-randomization, verified by MRR (test type, date, and result if available) and self-
report. 
 
Follow-up questionnaire: repeat of key psychosocial measures to explore mechanisms and 
acceptability. 
Outcome definitions (non-safety) 
 
CRC screening completion: Documentation in the medical record or self-report of colonoscopy, 
FIT, FIT-DNA, CT colonography, or flexible sigmoidoscopy performed within the 6-month window 
(plus any pre-specified grace period). 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
 
Exposure/dose metrics: Number of SMS delivered; proportion eliciting a response; 
number/proportion of videos opened by chapter; completion of the immediate post-education 
questionnaire; and elapsed days in PESA until closeout. 
Administration, scoring, and data quality 
 
Administration. All questionnaires are administered via telephone. 
 
Scoring. Multi-item scales are scored per codebook (sum or mean of valid items; higher scores 
reflect greater endorsement or knowledge, as defined). Missing-data rules (e.g., minimum items 
required) are pre-specified. 
 
Data capture. Survey responses and SMS telemetry are time-stamped and stored on the study 
platform; MRR uses standardized abstraction forms with dual review and reconciliation. 
Qualified personnel 
 
MRR: Conducted by trained study staff (e.g., clinic research coordinators) using a standardized 
abstraction guide; complex clinical ambiguities are adjudicated by a qualified clinician (e.g., 
physician or advanced practice provider). 
 
Telephone-based assessment: Conducted by trained study staff. 
Use of existing clinical data and HIPAA 
The study uses existing medical charts to verify CRC screening. HIPAA, applicable federal/state laws, and 
local institutional requirements are followed. MRR variables include test type and date (and result if 
available). No central lab is used; no CLIA-covered testing is performed by the study. 
Standard of care procedures 
All screening tests are ordered and performed as part of routine clinical care, independent of the 
research team. The study does not alter clinical pathways, rescue therapy, or provider decision-making. 
Results returned to participants 
Participants receive general educational messages and resource links through the intervention or 
control SMS sequences. The study does not generate new clinical test results; any clinical results (e.g., 
from a colonoscopy) are communicated by the healthcare system per usual care. 
 
8.2 
SAFETY ASSESSMENTS 
 
No physical examinations, performance tests, imaging, biospecimen collection, special assays, sensors, or 
EMA are performed by the study. Safety procedures consist of: (1) AE/SAE identification and follow-up; 
(2) monitoring for distress potentially triggered by educational content; and (3) privacy/technology 
safeguards (e.g., wrong-number texting, shared phones). AEs are any unfavorable or unintended 
psychological or practical effect temporally associated with participation in the study’s activities (videos, 
SMS, surveys), whether or not considered related. Examples include: heightened anxiety/distress about 
CRC risk, dissatisfaction with messaging frequency, perceived breach of privacy (e.g., texts seen by others 
on a shared device), or escalation of medical mistrust that prompts clinical concern. SAEs would be rare 
in this context and are defined per IRB policy (e.g., death, life-threatening event, hospitalization) 
regardless of attribution. 
 
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
No text is to be entered in this section; rather it should be included under the relevant subheadings below.  
 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
8.3.1 DEFINITION OF ADVERSE EVENTS 
 
An AE is defined as an event that is unexpected, related or possibly related to research participation, and 
suggests that the research places subjects or others at a greater risk of harm than was previously known 
or recognized. 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
 
An SAE is defined as an event that results in death, is life-threatening, results in inpatient hospitalization 
or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results 
in a congenital anomaly/birth defect, or may jeopardize the subject’s health and may require medical or 
surgical intervention to prevent one of the other outcomes listed. 
 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
8.3.3.1 SEVERITY OF EVENT 
 
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines will 
be used to describe severity.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”. 
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed based on temporal relationship. The degree of certainty about causality will be graded using the 
categories below.  
 
• 
Related – The AE is known to occur with the study procedures, there is a reasonable possibility 
that the study procedures caused the AE, or there is a temporal relationship between the study 
procedures and the event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study procedures and the AE. 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
• 
Not Related – There is not a reasonable possibility that the study procedures caused the event, 
there is no temporal relationship between the study procedures and event onset, or an alternate 
etiology has been established. 
 
8.3.3.3 EXPECTEDNESS  
 
A member of the research team with appropriate expertise will be responsible for determining whether 
an adverse event (AE) is expected or unexpected. An AE will be considered unexpected if the nature, 
severity, or frequency of the event is not consistent with the risk information previously described for the 
study procedures. 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study appointments. 
 
All AEs, not otherwise precluded per the protocol, will be captured on the appropriate case report form 
(CRF). Information to be collected includes event description, time of onset, assessment of severity, 
relationship to study procedures (assessed only by those with the training and authority to make a 
diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on study will be 
documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
 
Any medical or psychiatric condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s condition 
deteriorates at any time during the study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. Documentation of onset and duration of each episode will be 
maintained for AEs characterized as intermittent. 
 
The study coordinator will record events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.  At 
each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit.  Events 
will be followed for outcome information until resolution or stabilization. 
 
8.3.5 ADVERSE EVENT REPORTING  
 
Any AE or SAE, whether or not related to study intervention, will be reported to the IRB, NCI, and the 
Office for Human Research Protections (OHRP). SAE’s will be reported to the IRB within 24 hours and AEs 
will be reported to the IRB within 72 hours. All SAE’s and AE’s will be reported to NCI and OHRP within 
two weeks. The initial report will be followed by submission of a completed report to all institutions. 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
 
Any AE or SAE, whether or not related to study intervention, will be reported to the IRB, NCI, and the 
Office for Human Research Protections (OHRP). SAE’s will be reported to the IRB within 24 hours and AEs 
will be reported to the IRB within 72 hours. All SAE’s and AE’s will be reported to NCI and OHRP within 
two weeks. The initial report will be followed by submission of a completed report to all institutions. 
 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
 
N/A 
 
8.3.8 EVENTS OF SPECIAL INTEREST  
 
N/A 
 
8.3.9 REPORTING OF PREGNANCY  
 
N/A 
 
8.4 
UNANTICIPATED PROBLEMS 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
 
8.4.2  UNANTICIPATED PROBLEMS REPORTING  
 
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB). The UP report will include the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number 
• 
A detailed description of the event, incident, experience, or outcome  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP 
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
 
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB within 24 hours and to the 
funding agency within two weeks of the investigator becoming aware of the event  
• 
Any other UP will be reported to the IRB within 72 hours and to the funding agency within two 
weeks of the investigator becoming aware of the problem  
• 
All UPs should be reported to appropriate institutional officials (as required by an institution’s 
written reporting procedures), the supporting agency head (or designee), and the Office for 
Human Research Protections (OHRP) within two weeks of the IRB’s receipt of the report of the 
problem from the investigator. 
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 
N/A 
 
9 
STATISTICAL CONSIDERATIONS  
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
9.1 
STATISTICAL HYPOTHESES 
 
 
Primary Endpoint(s):  
We hypothesize that, compared to participants who receive standard educational materials via SMS 
(control), participants who receive the tailored mobile video+SMS intervention (m-CRCSi) will have a 
higher proportion completing any guideline-concordant colorectal cancer (CRC) screening within 6 
months post-randomization. Alternatively, our null hypothesis is that there will be no difference between 
arms in screening completion at 6 months. 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
 
 
Secondary Endpoint(s): 
 
Self-reported proxy screening composite (6 months): 
We hypothesize that the intervention arm will report a higher rate of any guideline-concordant CRC 
screening by 6 months than the control arm; the null hypothesis is that there will be no difference 
between arms. 
 
CRC knowledge (baseline→6 months): 
We hypothesize that intervention participants will show greater improvement in CRC knowledge from 
baseline to 6 months than control participants; the null hypothesis is that there will be no difference in 
change between arms. 
 
Perceived susceptibility and severity (baseline→6 months): 
We hypothesize that intervention participants will report greater increases in perceived susceptibility and 
severity from baseline to 6 months than control participants; the null hypothesis is that there will be no 
difference in change between arms. 
 
Perceived benefits and barriers for colonoscopy and stool testing (baseline→6 months): 
We hypothesize that intervention participants will report greater increases in perceived benefits and 
greater decreases in perceived barriers from baseline to 6 months than control participants; the null 
hypothesis is that there will be no difference in change between arms. 
 
Medical trust (baseline→6 months): 
We hypothesize that intervention participants will report greater increases in trust in the medical 
profession from baseline to 6 months than control participants; the null hypothesis is that there will be 
no difference in change between arms. 
 
Self-efficacy (overall; colonoscopy; stool test) and advocacy (baseline→6 months): 
We hypothesize that intervention participants will demonstrate greater improvements from baseline to 
6 months than control participants; the null hypothesis is that there will be no difference in change 
between arms. 
9.2 
SAMPLE SIZE DETERMINATION 
To determine the adequate sample size for our study, we examined achieved power and treatment 
effects for a study examining the efficacy of a conceptually similar intervention with an equivalent data 
analysis plan. Specifically, Miller et al. developed a digital decision aid to help patients select a CRC 
screening test before a primary care appointment. Compared to controls, participants assigned to the 
decision aid were twice as likely to get screened at 6-month followup (30% [67/223] vs. 15% [34/227], 
difference=15%, 95% CI 7% to 23%; OR = 2.5). Follow-up analyses with only nonwhite participants 
continued to show a significant positive effect on screening (34% [33/98] vs. 19% [18/94], difference = 
15%, 95% CI 6% to 25%; OR=1.79). Based on the similarity of this research to our own, we anticipate 
similar screening proportions in our study. To estimate power for the binomial logistic regression 
analysis on the primary outcome measure (MRR-verified CRC screening), we relied on the sub-analysis 
from Miller et al.’s data. Importantly, the OR in this analysis (1.79) is consistent with the average effect 
size of SMS-based interventions on health behaviors (OR=1.81). The G*Power 3.1 program was used to 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
determine that an odds ratio of 1.79, a two-tailed α error probability of 0.05, and 80% power requires a 
final sample size of 154 to detect an expected difference in screening rates of 15% at the 6-month 
follow-up. While unlikely, we will anticipate a conservative 20% attrition rate and set our sample size at 
193 (n= 154 post-attrition). 
 
As screening-related health beliefs are important secondary outcomes, we also examined power using 
treatment effects for screening self-efficacy from the Miller et al. decision aid study. Researchers found 
that participants in the intervention group reported significantly higher screening self-efficacy (n=223, 
M=3.89, SD=.84) than control participants (n=227, M=3.64, SD=1.00), p=.004. This difference is 
associated with a Cohen’s d = .27. To detect a difference of this size in screening self-efficacy, our study 
will require a final sample size of 110 participants (α = 0.05 two-tailed; power = .80). The 154 
participants remaining in the analyses post-attrition will be sufficient to detect differences health beliefs 
across the two survey time points. 
9.3 
POPULATIONS FOR ANALYSES 
 
Because randomization carries the expectation of creating treatment groups equivalent with respect to 
known and unknown prognostic factors, removing randomized participants from the analysis runs the risk 
of tampering with this balance and introducing bias into the treatment comparisons. As a result, an 
intention-to-treat analytic approach will be followed such that all participants randomized into the study 
will be included in all analyses irrespective of protocol violations post randomization. Even with our best 
efforts, we can expect some missing data. For the primary outcome, missing data will be limited to cases 
where we are unable to complete an MRR review. Because we will have medical releases for all 
participants on our primary outcome, very little missing data is anticipated. For secondary measures, 
missing data will consist of those who fail to complete the 6-month follow-up survey. We will conduct an 
initial evaluation of missingness by performing a series of logistic regression analyses where the indicator 
of missing data is the outcome and potential explanatory variables (e.g., condition, screening status, 
demographic characteristics) serve as predictors. We will then use imputation to manage missing data. 
 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
 
Binomial logistic regression will be the main analytic technique for the primary outcome (MRR-verified 
completion of a recommended CRC screening test). Logistic regression analyses will also examine 
treatment differences in type of screening received. For secondary outcomes, linear regression will be 
used. All analyses will control for any confounding variables not managed through randomization (i.e., 
group difference p <.10).  
 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 
For the primary outcome, if any missing data is identified, both negative and multiple imputation methods 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
will be used to estimate CRC screening completion. This approach to missing data was successfully used 
by Vernon and colleagues (Kinney et al, 2014; Steffen et al, 2015). Negative outcome imputation will 
assume that if there was no MRR-verified CRC screening, the procedure did not occur. Multiple imputation 
will be based on experimental condition, age at baseline, income, health insurance coverage, and any 
other covariates predictive of missingness in the imputation model. Twenty imputed datasets will be used 
to provide a combined estimate for missing values. We will employ SAS PROC MI and SAS PROC 
MIANALYZE, Version 9.4, to implement these imputation procedures. We will also conduct a complete 
case analysis including only those participants with a known primary outcome.  
 
 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
Linear regression will be used to assess secondary outcomes. All analyses will control for any confounding 
variables not managed through randomization (i.e., group difference p <.10). For the secondary outcomes, 
we will conduct multiple imputation for any missing data using the procedures described for the primary 
outcome. 
 
9.4.4 SAFETY ANALYSES 
 
N/A 
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
All analyses will control for any confounding variables not managed through randomization (i.e., group 
difference p <.10). 
 
9.4.6 PLANNED INTERIM ANALYSES  
 
N/A 
9.4.7 SUB-GROUP ANALYSES 
 
Study intervention is only for men. 
 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
Individual participant data will not be listed by measure and time point. 
 
9.4.9 EXPLORATORY ANALYSES 
 
N/A 
 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
10.1.1 INFORMED CONSENT PROCESS 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
 
 
Consent forms describing in detail the study intervention, study procedures, and risks will be given to the 
participant and written documentation of informed consent will be completed prior to starting the study 
intervention. 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
The field test coordinator will provide eligible men with a detailed overview of the main points of the 
study. First, participants will be reminded that, although health information of a sensitive nature will be 
included in the intervention or control materials and the survey, their names will not be associated with 
their survey responses or their assigned materials. The field test coordinator will also explain the flow of 
the study procedures and what will be asked of participants. Participants will be told that the two 
surveys – the baseline survey and a follow-up survey six months later – will take approximately one hour 
to complete. They will also be informed that their medical records will be checked again at the end of 
the study to verify whether they received CRC screening since the study began. Further, men will be told 
that half of the participants will be asked to go through the m-CRCSi after the first survey while the 
other half will review CRC materials developed by the CDC via a link texted to their study phone number. 
Those who do not go through the m-CRCSi will be given access to it after the second survey. All 
participants will be informed that they will complete the research surveys via telephone with the study 
coordinator reading the questions and recording participant responses. They will also be told that their 
assigned materials can all be reviewed remotely on their smartphones. Procedures for mobile phone 
safety will be reviewed. Finally, the field test coordinator will also explain that participants will receive 
$75 for completing the baseline survey and $100 for completing the 6-month follow-up survey. Once 
any participant questions are answered, eligible men will be sent a text message linking to the informed 
consent form. Next, the potential participant will review the informed consent document. The ISA staff 
member will remain on the phone while potential participants review the informed consent and will 
encourage them to ask any questions they may have about the study.  

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
Men who agree to participate will acknowledge their consent by tapping a button labeled “I have read 
the above and AGREE to participate.” Men who choose not to participate will click a button labeled “I DO 
NOT AGREE and do not want to participate.” Those who choose not to participate after reading the 
informed consent will be thanked for their time and released. All participants will receive a copy of the 
text message via their preferred channel (e.g., mailed paper copy, texted PDF) for their personal records. 
The copy will be identical to the digital version. In addition, the consent form will have the name and toll-
free telephone number of the Principal Investigator and the IRB Chairperson if participants have any 
additional questions. 
 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. If the study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly 
inform study participants, the Institutional Review Board (IRB), and sponsor/funding agency and will 
provide the reason(s) for the termination or suspension. Study participants will be contacted, as 
applicable, and be informed of changes to study appointment schedule. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
 
Determination of unexpected, significant, or unacceptable risk to participants 
 
Insufficient compliance of study staff to the protocol (ie, significant protocol violations) 
 
Determination that the primary endpoint has been met 
 
Determination of futility 
 
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency, sponsor, IRB, , or other relevant regulatory or oversight bodies (OHRP). 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
the safety and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a specific 
study participant will be held in strict confidence within the research team. No personally-identifiable 
information from the study will be released to any unauthorized third party without prior written approval 
of the sponsor/funding agency.  
 
All research activities will be conducted in as private a setting as possible. 
To maintain confidentiality of all data collected, no names or other identifying information will be 
included with the recorded MRR screening data, on the survey, or as part of m-CRCSi or the control 
materials. As noted earlier, the file that will link the participant name to the user ID and study phone 
number will be maintained on a password protected computer that will not house the survey data. The 
only people that will have access to the linking file will be the Principal Investigator and her staff. Finally, 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
we will utilize strict security protocols – described previously – to protect the confidentiality of all 
information transmitted via SMS and stored on our secure server as part of the m-CRCSi intervention.  
To protect against any breaches of confidentiality, all project staff proposed to conduct the data 
collection have received or will receive training on the protection of research participants and are or will 
be well versed in the Code of Federal Regulations (including 45 CFR 46 and 42 CFR) and the Belmont 
Report. ISA continually obtains information from the Office for Human Research Protections (OHRP) at 
NIH on new regulations regarding the protection of human subjects, which is disseminated to all staff. 
Further, participants will have the MRR procedure explained to them and will be asked to complete a 
medical release form before any medical records are extracted. In addition, any ISA staff proposed to 
work on the MRR and EHR extraction are or will be trained in all applicable HIPAA regulations. 
After all participants have completed follow-up surveys, the linking file housed on the ISA computer – 
the only file that contains participant’s personal information (e.g., name, phone number) – will be 
deleted. In addition, the Windows Eraser program will be used to completely remove (i.e., “wipe”) the 
linking file from the computer by overwriting it several times using government-sanctioned deletion 
algorithms.  
It is NIH policy that the results and accomplishments of the activities that it funds should be made available 
to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms used to 
share data will include proper plans and safeguards for the protection of privacy, confidentiality, and 
security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be 
traceable to a specific study participant). Plans for archiving and long-term preservation of the data will 
be implemented, as appropriate.  
 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
Deidentified participant research data from the baseline and follow-up surveys will be retained for 3 
years from the submission of the final financial report to NIH, in keeping with guidelines described in the 
NIH Grants Policy Statement. 
 
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
Provide the name and contact information of the Principal Investigator and the Medical Monitor or 
Independent Safety Monitor. Update table heading to remove non-relevant role. 
Principal Investigator
Samantha Leaf, Ph.D.
ISA Associates, Inc.
4501 Fairfax Dr, Ste 601
Arlington, VA 22203 
703-739-0880
sleaf@isagroup.com
 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
10.1.6 SAFETY OVERSIGHT 
 
Samantha Leaf, Ph.D., the PI, has the responsibility for assessing adverse events (AEs) and serious adverse 
events (SAEs) and the ultimate responsibility for all data and safety monitoring. She will conduct weekly 
reviews of any problems related to quality of data collection, transmission, or analyses and of any AEs and 
SAEs that occurred in the past week.  Further, she will conduct annual reviews of SAEs associated with 
renewal of IRB approval. 
10.1.7 CLINICAL MONITORING 
 
N/A 
 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
We will perform internal quality management of study conduct, data collection, documentation and 
completion.  
 
Quality control (QC) procedures will be implemented as follows: 
 
Informed consent --- Study staff will review both the documentation of the consenting process as well as 
a percentage of the completed consent documents.  This review will evaluate compliance, accuracy, and 
completeness.  Feedback will be provided to the study team to ensure proper consenting procedures are 
followed.  
 
Source documents and the electronic data --- Baseline and follow-up survey data will be captured directly 
in the study database.  MRR data will be initially captured via a secure file and transcribed into the study 
database. All MRR entries will be checked for accuracy by a second study team member. 
 
Intervention Fidelity — Intervention is delivered electronically. Periodic monitoring will check for errors.  
 
Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern. 
10.1.9 DATA HANDLING AND RECORD KEEPING  
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
Data collection will be the responsibility of the study staff under the supervision of the site investigator. 
The investigator will be responsible for ensuring the accuracy, completeness, legibility, and timeliness of 
the data reported. 
 
All source data will be completed electronically to ensure legibility.   
 
10.1.9.2 STUDY RECORDS RETENTION  
 
Deidentified participant research data from the baseline and follow-up surveys will be retained for 3 years 
from the submission of the final financial report to NIH, in keeping with guidelines described in the NIH 
Grants Policy Statement. No records will be destroyed without the written consent of the sponsor/funding 
agency, if applicable. It is the responsibility of the sponsor/funding agency to inform the investigator when 
these documents no longer need to be retained. 
 
10.1.10 
PROTOCOL DEVIATIONS   
 
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council on Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) 
requirements. The noncompliance may be either on the part of the participant, the investigator, or the 
study site staff. As a result of deviations, corrective actions will be developed by the site and implemented 
promptly.  
 
These practices are consistent with ICH GCP:  
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3  
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1  
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.  
 
It will be the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 5 working days of identification of the protocol deviation. All deviations will be 
addressed in study source documents. Protocol deviations will be sent to the reviewing Institutional 
Review Board (IRB) per their policies. The site investigator will be responsible for knowing and adhering 
to the reviewing IRB requirements.  
10.1.11 
PUBLICATION AND DATA SHARING POLICY  
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed 
journals.  Data from this study may be requested from other researchers 10 years after the completion of 
the primary endpoint by contacting ISA.   
 
10.1.12 
CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence is critical. Therefore, any actual 
conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect 
of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict of interest 
will be required to have such conflicts managed in a way that is appropriate to their participation in the 
design and conduct of this trial. The study leadership has established policies and procedures for all study 
group members to disclose all conflicts of interest and will establish a mechanism for the management of 
all reported dualities of interest. 
10.2 ADDITIONAL CONSIDERATIONS 
 
N/A 
 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
 
AE
Adverse Event
CFR
Code of Federal Regulations
CLIA
Clinical Laboratory Improvement Amendments
CRC
Colorectal Cancer
CRF
Case Report Form
DHHS
Department of Health and Human Services
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act 
ICH
International Council on Harmonisation
IRB
Institutional Review Board
ITT
Intention-To-Treat
MOP
Manual of Procedures
NCT
National Clinical Trial
NIH 
National Institutes of Health
NIH IC
NIH Institute or Center

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
OHRP
Office for Human Research Protections
PI
Principal Investigator
QA
Quality Assurance
QC
Quality Control
RCT
Randomized Controlled Trial
SAE
Serious Adverse Event
SOP
Standard Operating Procedure
UP
Unanticipated Problem
US
United States
 
 
 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
10.4 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 
Version
Date
Description of Change 
Brief Rationale
n/a
n/a
n/a
n/a
 
11 REFERENCES  
1. 
Singh GK, Jemal A. Socioeconomic and Racial/Ethnic Disparities in Cancer Mortality, Incidence, and 
Survival in the United States, 1950–2014: Over Six Decades of Changing Patterns and Widening 
Inequalities. J Environ Public Health. 2017;1-19. doi:10.1155/2017/2819372 
2. 
American Cancer Society. Colorectal Cancer Facts & Figures 2017-2019. Atlanta: American Cancer 
Society; 2017. 
3. 
American Psychological Association. (n.d.) Ethnic and Racial Minorities & Socioeconomic Status. 
https://www.apa.org/pi/ses/resources/publications/minorities. Accessed April 1, 2019. 
4. 
World Health Organization. (n.d.). Social determinants of health. http://www.who.int/ 
social_determinants/sdh_definition/en/. Accessed September 1, 2018. 
5. 
U.S. Department of Health and Human Services. The Secretary’s Advisory Committee on National 
Health Promotion and Disease Prevention Objectives for 2020. Phase I report: Recommendations 
for the framework and format of Healthy People 2020. 2008. 
http://www.healthypeople.gov/sites/default/ files/PhaseI_0.pdf. Accessed September 1, 2018. 
6. 
Fontenot K, Semega J, Kollar M. U.S. Census Bureau, Current Population Reports, P60-263, Income 
and Poverty in the United States: 2017, U.S. Government Printing Office, Washington, DC, 2018. 
7. 
American Cancer Society. Cancer Facts & Figures for African Americans 2016-2018. Atlanta: 
American Cancer Society, 2016. 
8. 
Surveillance Epidemiology and End Results Program. SEER Stat Facts Sheet: colon and rectum. 
Available at: http://seer.cancer.gov/statfacts/html/colorect.html. Accessed March 1, 2019. 
9. 
Ransohoff DF. How much does colonoscopy reduce colon cancer mortality? Ann Intern Med. 2009.  
150(1): 50-52. 
10. 
Doubeni CA, Corley DA, Quinn VP, Jensen CD, Zauber AG, Goodman M, Johnson JR, Mehta SJ, 
Becerra TA, Zhao WK, Schottinger J, Doria-Rose VP, Levin TR, Weiss NS, Fletcher RH. Effectiveness 
of screening colonoscopy in reducing the risk of death from right and left colon cancer: a large 
community-based study. Gut. 2018 Feb;67(2):291-298. doi: 10.1136/gutjnl-2016-312712. Epub 
2016 Oct 12. PMID: 27733426; PMCID: PMC5868294. 
11. 
Lansdorp-Vogelaar I, Kuntz KM, Knudsen AB, van Ballegooijen M, Zauber AG, Jemal A. Contribution 
of screening and survival differences to racial disparities in colorectal cancer rates. Cancer 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
Epidemiol Biomarkers Prev. 2012 May;21(5):728-36. doi: 10.1158/1055-9965.EPI-12-0023. Epub 
2012 Apr 18. PMID: 22514249; PMCID: PMC3531983. 
12. 
Bromley EG, May FP, Federer L, Spiegel BM, van Oijen MG. Explaining persistent under-use of 
colonoscopic cancer screening in African Americans: a systematic review. Prev Med. 2015 
Feb;71:40-8. doi: 10.1016/j.ypmed.2014.11.022. Epub 2014 Dec 4. PMID: 25481094; PMCID: 
PMC4329030. 
13. 
Jerant AF, Fenton JJ, Franks P. Determinants of racial/ethnic colorectal cancer screening 
disparities. Arch Intern Med. 2008 Jun 23;168(12):1317-24. doi: 10.1001/archinte.168.12.1317. 
PMID: 18574089. 
14. 
Rogers CR, Goodson P, Dietz LR, Okuyemi KS. Predictors of Intention to Obtain Colorectal Cancer 
Screening Among African American Men in a State Fair Setting. Am J Mens Health. 2018 
Jul;12(4):851-862. doi: 10.1177/1557988316647942. Epub 2016 May 8. PMID: 27161985; PMCID: 
PMC5101175. 
15. 
Klasko-Foster LB, Jandorf LM, Erwin DO, Kiviniemi MT. Predicting Colonoscopy Screening Behavior 
and Future Screening Intentions for African Americans Older than 50 Years. Behav Med. 2019 Jul-
Sep;45(3):221-230. doi: 10.1080/08964289.2018.1510365. Epub 2018 Nov 14. PMID: 30427773; 
PMCID: PMC6517076. 
16. 
Rogers CR, Matthews P, Xu L, Boucher K, Riley C, Huntington M, et al. (2020) Interventions for 
increasing colorectal cancer screening uptake among African-American men: A systematic review 
and meta-analysis. PLoS ONE 15(9): e0238354. https://doi.org/10.1371/journal.pone.0238354 
17. 
Smith A, Page D. U.S. Smartphone Use in 2015. 2015. http://www.pewinternet.org/files/2015/03/ 
PI_Smartphones_0401151.pdf. Accessed September 1, 2016. 
18. 
Anderson M. Technology Device Ownership: 2015. 2015. 
http://www.pewinternet.org/2015/10/29/ technology-device-ownership-2015. Accessed 
September 1, 2016. 
19. 
Pew Research Center. Millennials stand out for their technology use, but older generations also 
embrace digital life. May 2018. https://www.pewresearch.org/fact-tank/2018/05/02/millennials-
stand-out-for-their-technology-use-but-older-generations-also-embrace-digital-life/. Accessed 
March 26, 2019. 
20. 
Pew Research Center. American Trends Panel Experience Sampling Survey. In The Smartphone 
Difference, 8. 2014. Washington, DC: Pew Research Center. 
21. 
Uy C, Lopez J, Trinh-Shevrin C, Kwon SC, Sherman SE, Liang PS. Text Messaging Interventions on 
Cancer Screening Rates: A Systematic Review. J Med Internet Res. 2017 Aug 24;19(8):e296. doi: 
10.2196/jmir.7893. PMID: 28838885; PMCID: PMC5590008. 
22. 
Weaver KE, Ellis SD, Denizard-Thompson N, Kronner D, Miller DP. Crafting Appealing Text 
Messages to Encourage Colorectal Cancer Screening Test Completion: A Qualitative Study. JMIR 
Mhealth Uhealth. 2015 Nov 4;3(4):e100. doi: 10.2196/mhealth.4651. PMID: 26537553; PMCID: 
PMC4704950. 
23. 
Jones AR, Moser DK, Hatcher J. Using text messages to promote health in African-Americans: 
#HeartHealthyandCancerFree. Ethn Health. 2018 Apr;23(3):307-320. doi: 
10.1080/13557858.2016.1263289. Epub 2016 Nov 29. PMID: 27897049. 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
24. 
Mehta SJ, Oyalowo A, Reitz C, et al. Text messaging and lottery incentive to improve colorectal 
cancer screening outreach at a community health center: A randomized controlled trial. Prev Med 
Rep. 2020;19:101114. Published 2020 May 8. doi:10.1016/j.pmedr.2020.101114 
25. 
Higgins AY, Doubeni AR, Phillips KL, Laiyemo AO, Briesacher B, Tjia J, Doubeni CA. Self-reported 
colorectal cancer screening of Medicare beneficiaries in family medicine vs. internal medicine 
practices in the United States: a cross-sectional study. BMC Gastroenterol. 2012 Mar 21;12:23. 
doi: 10.1186/1471-230X-12-23. PMID: 22436107; PMCID: PMC3352176. 
26. 
Becker MH. The health belief model and personal health behavior. Health Educ Monogr. 1974. 
Vol. 2 No. 4. 
27. 
Coughlin SS, Blumenthal DS, Seay SJ, Smith SA. Toward the Elimination of Colorectal Cancer 
Disparities Among African Americans. J Racial Ethn Health Disparities. 2016 Dec;3(4):555-564. doi: 
10.1007/s40615-015-0174-z. Epub 2015 Oct 28. PMID: 27294749; PMCID: PMC4911324. 
28. 
Friedman DB, Hoffman-Goetz L. Assessment of cultural sensitivity of cancer information in ethnic 
print media. J Health Commun. 2006 Jun;11(4):425-47. doi: 10.1080/10810730600671920. PMID: 
16720539.  
29. 
Coleman C. Teaching health care professionals about health literacy: a review of the literature. 
Nurs Outlook. 2011 Mar-Apr;59(2):70-8. doi: 10.1016/j.outlook.2010.12.004. PMID: 21402202. 
30. 
Rogers CR, Goodson P. Male Role Norms, Knowledge, Attitudes, and Perceptions of Colorectal 
Cancer Screening among Young Adult African American Men. Front Public Health. 2014 Nov 
27;2:252. doi: 10.3389/fpubh.2014.00252. PMID: 25506049; PMCID: PMC4245902. 
31. 
Williams RM, Wilkerson T, Holt CL. The role of perceived benefits and barriers in colorectal cancer 
screening in intervention trials among African Americans. Health Educ Res. 2018 Jun 1;33(3):205-
217. doi: 10.1093/her/cyy013. PMID: 29757376; PMCID: PMC5961187. 
32. 
Kreuter MW, Lukwago SN, Bucholtz RD, Clark EM, Sanders-Thompson V. Achieving cultural 
appropriateness in health promotion programs: targeted and tailored approaches. Health Educ 
Behav. 2003 Apr;30(2):133-46. doi: 10.1177/1090198102251021. PMID: 12693519. 
33. 
US Preventive Services Task Force, Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, 
Epling JW Jr, García FAR, Gillman MW, Harper DM, Kemper AR, Krist AH, Kurth AE, Landefeld CS, 
Mangione CM, Owens DK, Phillips WR, Phipps MG, Pignone MP, Siu AL. Screening for Colorectal 
Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jun 
21;315(23):2564-2575. doi: 10.1001/jama.2016.5989. Erratum in: JAMA. 2016 Aug 2;316(5):545. 
Erratum in: JAMA. 2017 Jun 6;317(21):2239. PMID: 27304597. 
34. 
Uraoka T, Hosoe N, Yahagi N. Colonoscopy: is it as effective as an advanced diagnostic tool for 
colorectal cancer screening? Expert Rev Gastroenterol Hepatol. 2015 Feb;9(2):129-32. doi: 
10.1586/17474124.2015.960397. Epub 2014 Sep 25. PMID: 25252803. 
35. 
DeBourcy AC, Lichtenberger S, Felton S, Butterfield KT, Ahnen DJ, Denberg TD. Community-based 
preferences for stool cards versus colonoscopy in colorectal cancer screening. J Gen Intern Med. 
2008 Feb;23(2):169-74. doi: 10.1007/s11606-007-0480-1. Epub 2007 Dec 21. PMID: 18157581; 
PMCID: PMC2359177. 
36. 
Peipins LA, Soman A, Berkowitz Z, White MC. The lack of paid sick leave as a barrier to cancer 
screening and medical care-seeking: results from the National Health Interview Survey. BMC 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
Public Health. 2012 Jul 12;12:520. doi: 10.1186/1471-2458-12-520. PMID: 22788387; PMCID: 
PMC3433348. 
37. 
Gupta S, Sussman DA, Doubeni CA, Anderson DS, Day L, Deshpande AR, Elmunzer BJ, Laiyemo AO, 
Mendez J, Somsouk M, Allison J, Bhuket T, Geng Z, Green BB, Itzkowitz SH, Martinez ME. 
Challenges and possible solutions to colorectal cancer screening for the underserved. J Natl Cancer 
Inst. 2014 Apr;106(4):dju032. doi: 10.1093/jnci/dju032. Epub 2014 Mar 28. PMID: 24681602; 
PMCID: PMC3982886. 
38. 
Hall IJ, Tangka FKL, Sabatino SA, Thompson TD, Graubard BI, Breen N. Patterns and Trends in 
Cancer Screening in the United States. Prev Chronic Dis. 2018 Jul 26;15:E97. doi: 
10.5888/pcd15.170465. PMID: 30048233; PMCID: PMC6093265. 
39. 
National Cancer Institute. Cancer Trends Progress Report: Colorectal Cancer Screening. 
https://progressreport.cancer.gov/detection/colorectal_cancer. Accessed March 19, 2019. 
40. 
Wilkins T, Gillies RA, Harbuck S, Garren J, Looney SW, Schade RR. Racial disparities and barriers to 
colorectal cancer screening in rural areas. J Am Board Fam Med. 2012 May-Jun;25(3):308-17. doi: 
10.3122/jabfm.2012.03.100307. PMID: 22570394. 
41. 
James AS, Daley CM, Greiner KA. Knowledge and attitudes about colon cancer screening among 
African Americans. Am J Health Behav. 2011 Jul;35(4):393-401. doi: 10.5993/ajhb.35.4.2. PMID: 
22040586; PMCID: PMC3724401. 
42. 
Holt CL, Shipp M, Eloubeidi M, Clay KS, Smith-Janas MA, Janas MJ, Britt K, Norena M, Fouad MN. 
Use of focus group data to develop recommendations for demographically segmented colorectal 
cancer educational strategies. Health Educ Res. 2009 Oct;24(5):876-89. doi: 10.1093/her/cyp024. 
Epub 2009 Apr 24. PMID: 19395624. 
43. 
Lukin DJ, Jandorf LH, Dhulkifl RJ, Thélémaque LD, Christie JA, Itzkowitz SH, Duhamel KN. Effect of 
comorbid conditions on adherence to colorectal cancer screening. J Cancer Educ. 2012 
Jun;27(2):269-76. doi: 10.1007/s13187-011-0303-2. PMID: 22351374; PMCID: PMC3778660. 
44. 
Coughlin SS, Thompson T. Physician recommendation for colorectal cancer screening by race, 
ethnicity, and health insurance status among men and women in the United States, 2000. Health 
Promot Pract. 2005 Oct;6(4):369-78. doi: 10.1177/1524839905278742. PMID: 16210678. 
45. 
Kangovi S, Barg FK, Carter T, Long JA, Shannon R, Grande D. Understanding why patients of low 
socioeconomic status prefer hospitals over ambulatory care. Health Aff (Millwood). 2013 
Jul;32(7):1196-203. doi: 10.1377/hlthaff.2012.0825. PMID: 23836734. 
46. 
Ruggieri DG, Bass SB, Rovito MJ, Ward S, Gordon TF, Paranjape A, Lin K, Meyer B, Parameswaran L, 
Wolak C, Britto J, Ruzek SB. Perceived colonoscopy barriers and facilitators among urban African 
American patients and their medical residents. J Health Commun. 2013;18(4):372-90. doi: 
10.1080/10810730.2012.727961. Epub 2013 Jan 23. PMID: 23343400. 
47. 
Ward SH, Parameswaran L, Bass SB, Paranjape A, Gordon TF, Ruzek SB. Resident physicians' 
perceptions of barriers and facilitators to colorectal cancer screening for African Americans. J Natl 
Med Assoc. 2010 Apr;102(4):303-11. doi: 10.1016/s0027-9684(15)30602-7. PMID: 20437737. 
48. 
van Ryn M, Burke J. The effect of patient race and socio-economic status on physicians' 
perceptions of patients. Soc Sci Med. 2000 Mar;50(6):813-28. doi: 10.1016/s0277-9536(99)00338-
x. PMID: 10695979. 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
49. 
Beeker C, Kraft JM, Southwell BG, Jorgensen CM. Colorectal cancer screening in older men and 
women: qualitative research findings and implications for intervention. J Community Health. 2000 
Jun;25(3):263-78. doi: 10.1023/a:1005104406934. PMID: 10868818.  
50. 
Winterich JA, Quandt SA, Grzywacz JG, Clark P, Dignan M, Stewart JH, Arcury TA. Men's knowledge 
and beliefs about colorectal cancer and 3 screenings: education, race, and screening status. Am J 
Health Behav. 2011 Sep;35(5):525-34. doi: 10.5993/ajhb.35.5.2. PMID: 22040614; PMCID: 
PMC3670612. 
51. 
Greiner KA, Born W, Nollen N, Ahluwalia JS. Knowledge and perceptions of colorectal cancer 
screening among urban African Americans. J Gen Intern Med. 2005 Nov;20(11):977-83. doi: 
10.1111/j.1525-1497.2005.00165.x. PMID: 16307620; PMCID: PMC1490251. 
52. 
Adams LB, Richmond J, Corbie-Smith G, Powell W. Medical Mistrust and Colorectal Cancer 
Screening Among African Americans. J Community Health. 2017 Oct;42(5):1044-1061. doi: 
10.1007/s10900-017-0339-2. PMID: 28439739; PMCID: PMC5654700. 
53. 
Sly JR, Edwards T, Shelton RC, Jandorf L. Identifying barriers to colonoscopy screening for 
nonadherent African American participants in a patient navigation intervention. Health Educ 
Behav. 2013 Aug;40(4):449-57. doi: 10.1177/1090198112459514. Epub 2012 Oct 19. PMID: 
23086556; PMCID: PMC3695062. 
54. 
Armstrong K, Ravenell KL, McMurphy S, Putt M. Racial/ethnic differences in physician distrust in 
the United States. Am J Public Health. 2007 Jul;97(7):1283-9. doi: 10.2105/AJPH.2005.080762. 
Epub 2007 May 30. PMID: 17538069; PMCID: PMC1913079. 
55. 
Brittain K, Christy SM, Rawl SM. African American patients' intent to screen for colorectal cancer: 
Do cultural factors, health literacy, knowledge, age and gender matter? J Health Care Poor 
Underserved. 2016 Feb;27(1):51-67. doi: 10.1353/hpu.2016.0022. PMID: 27182187; PMCID: 
PMC4862574. 
56. 
Rikard RV, Thompson MS, McKinney J, Beauchamp A. Examining health literacy disparities in the 
United States: a third look at the National Assessment of Adult Literacy (NAAL). BMC Public 
Health. 2016 Sep 13;16(1):975. doi: 10.1186/s12889-016-3621-9. PMID: 27624540; PMCID: 
PMC5022195. 
57. 
Kiviniemi MT, Klasko-Foster LB, Erwin DO, Jandorf L. Decision-making and socioeconomic 
disparities in colonoscopy screening in African Americans. Health Psychol. 2018 May;37(5):481-
490. doi: 10.1037/hea0000603. Epub 2018 Mar 29. PMID: 29595298; PMCID: PMC5920714. 
58. 
Powe BD, Faulkenberry R, Harmond L. A review of intervention studies that seek to increase 
colorectal cancer screening among African-Americans. Am J Health Promot. 2010 Nov-
Dec;25(2):92-9. doi: 10.4278/ajhp.080826-LIT-162. PMID: 21039289. 
59. 
Ward SH, Lin K, Meyer B, Bass SB, Parameswaran L, Gordon TF, Ruzek SB. Increasing colorectal 
cancer screening among African Americans, linking risk perception to interventions targeting 
patients, communities and clinicians. J Natl Med Assoc. 2008 Jun;100(6):748-58. doi: 
10.1016/s0027-9684(15)31356-0. PMID: 18595582. 
60. 
Niederdeppe J, Levy AG. Fatalistic beliefs about cancer prevention and three prevention 
behaviors. Cancer Epidemiol Biomarkers Prev. 2007 May;16(5):998-1003. doi: 10.1158/1055-
9965.EPI-06-0608. PMID: 17507628. 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
61. 
Powe BD, Finnie R. Cancer fatalism: the state of the science. Cancer Nurs. 2003 Dec;26(6):454-65; 
quiz 466-7. doi: 10.1097/00002820-200312000-00005. PMID: 15022977. 
62. 
Philip EJ, DuHamel K, Jandorf L. Evaluating the impact of an educational intervention to increase 
CRC screening rates in the African American community: a preliminary study. Cancer Causes 
Control. 2010 Oct;21(10):1685-91. doi: 10.1007/s10552-010-9597-3. Epub 2010 Jun 10. PMID: 
20535541; PMCID: PMC3621716. 
63. 
Miles A, Rainbow S, von Wagner C. Cancer fatalism and poor self-rated health mediate the 
association between socioeconomic status and uptake of colorectal cancer screening in England. 
Cancer Epidemiol Biomarkers Prev. 2011 Oct;20(10):2132-40. doi: 10.1158/1055-9965.EPI-11-
0453. Epub 2011 Sep 27. PMID: 21953115; PMCID: PMC3199581. 
64. 
Taylor V, Lessler D, Mertens K, Tu SP, Hart A, Chan N, Shu J, Thompson B. Colorectal cancer 
screening among African Americans: the importance of physician recommendation. J Natl Med 
Assoc. 2003 Sep;95(9):806-12. PMID: 14527047; PMCID: PMC2594456.  
65. 
James AS, Campbell MK, Hudson MA. Perceived barriers and benefits to colon cancer screening 
among African Americans in North Carolina: how does perception relate to screening behavior? 
Cancer Epidemiol Biomarkers Prev. 2002 Jun;11(6):529-34. PMID: 12050093. 
66. 
Palmer RC, Midgette LA, Dankwa I. Colorectal cancer screening and African Americans: findings 
from a qualitative study. Cancer Control. 2008 Jan;15(1):72-9. doi: 10.1177/107327480801500109. 
PMID: 18094663. 
67. 
Lipkus IM, Lyna PR, Rimer BK. Colorectal cancer risk perceptions and screening intentions in a 
minority population. J Natl Med Assoc. 2000 Oct;92(10):492-500. PMID: 11105730; PMCID: 
PMC2608546. 
68. 
U.S. Preventive Services Task Force. Increasing Colorectal Cancer Screening: Multicomponent 
Interventions. Bethesda (MD): August 2016. https://www.thecommunityguide.org/sites/default/ 
files/assets/Cancer-Screening-Multicomponent-Colorectal.pdf. Accessed February 28, 2019. 
69. 
Naylor K, Ward J, Polite BN. Interventions to improve care related to colorectal cancer among 
racial and ethnic minorities: a systematic review. J Gen Intern Med. 2012 Aug;27(8):1033-46. doi: 
10.1007/s11606-012-2044-2. PMID: 22798214; PMCID: PMC3403155. 
70. 
Rawl SM, Menon U, Burness A, Breslau ES. Interventions to promote colorectal cancer screening: 
an integrative review. Nurs Outlook. 2012 Jul-Aug;60(4):172-181.e13. doi: 
10.1016/j.outlook.2011.11.003. Epub 2012 Jan 18. PMID: 22261002; PMCID: PMC3366042. 
71. 
Morgan PD, Fogel J, Tyler ID, Jones JR. Culturally targeted educational intervention to increase 
colorectal health awareness among African Americans. J Health Care Poor Underserved. 2010 
Aug;21(3 Suppl):132-47. doi: 10.1353/hpu.0.0357. PMID: 20675951. 
72. 
Menon U, Belue R, Wahab S, Rugen K, Kinney AY, Maramaldi P, Wujcik D, Szalacha LA. A 
randomized trial comparing the effect of two phone-based interventions on colorectal cancer 
screening adherence. Ann Behav Med. 2011 Dec;42(3):294-303. doi: 10.1007/s12160-011-9291-z. 
PMID: 21826576; PMCID: PMC3232176. 
73. 
Blumenthal DS, Smith SA, Majett CD, Alema-Mensah E. A trial of 3 interventions to promote 
colorectal cancer screening in African Americans. Cancer. 2010 Feb 15;116(4):922-9. doi: 
10.1002/cncr.24842. PMID: 20052732; PMCID: PMC2819540. 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
74. 
Lasser KE, Murillo J, Lisboa S, Casimir AN, Valley-Shah L, Emmons KM, Fletcher RH, Ayanian JZ. 
Colorectal cancer screening among ethnically diverse, low-income patients: a randomized 
controlled trial. Arch Intern Med. 2011 May 23;171(10):906-12. doi: 
10.1001/archinternmed.2011.201. PMID: 21606094. 
75. 
Percac-Lima S, Grant RW, Green AR, Ashburner JM, Gamba G, Oo S, Richter JM, Atlas SJ. A 
culturally tailored navigator program for colorectal cancer screening in a community health 
center: a randomized, controlled trial. J Gen Intern Med. 2009 Feb;24(2):211-7. doi: 
10.1007/s11606-008-0864-x. PMID: 19067085; PMCID: PMC2628981. 
76. 
Baker DW, Brown T, Buchanan DR, Weil J, Balsley K, Ranalli L, Lee JY, Cameron KA, Ferreira MR, 
Stephens Q, Goldman SN, Rademaker A, Wolf MS. Comparative effectiveness of a multifaceted 
intervention to improve adherence to annual colorectal cancer screening in community health 
centers: a randomized clinical trial. JAMA Intern Med. 2014 Aug;174(8):1235-41. doi: 
10.1001/jamainternmed.2014.2352. PMID: 24934845. 
77. 
Davis T, Arnold C, Rademaker A, Bennett C, Bailey S, Platt D, Reynolds C, Liu D, Carias E, Bass P 3rd, 
Wolf M. Improving colon cancer screening in community clinics. Cancer. 2013 Nov 1;119(21):3879-
86. doi: 10.1002/cncr.28272. Epub 2013 Aug 20. PMID: 24037721; PMCID: PMC3805687. 
78. 
Carethers JM. Clinical and Genetic Factors to Inform Reducing Colorectal Cancer Disparitites in 
African Americans. Front Oncol. 2018 Nov 20;8:531. doi: 10.3389/fonc.2018.00531. PMID: 
30524961; PMCID: PMC6256119. 
79. 
Bensink ME, Ramsey SD, Battaglia T, Fiscella K, Hurd TC, McKoy JM, Patierno SR, Raich PC, Seiber 
EE, Warren-Mears V, Whitley E, Paskett ED, Mandelblatt S; Patient Navigation Research Program. 
Costs and outcomes evaluation of patient navigation after abnormal cancer screening: evidence 
from the Patient Navigation Research Program. Cancer. 2014 Feb 15;120(4):570-8. doi: 
10.1002/cncr.28438. Epub 2013 Oct 25. PMID: 24166217; PMCID: PMC3946403. 
80. 
Liss DT, French DD, Buchanan DR, Brown T, Magner BG, Kollar S, Baker DW. Outreach for Annual 
Colorectal Cancer Screening: A Budget Impact Analysis for Community Health Centers. Am J Prev 
Med. 2016 Feb;50(2):e54-61. doi: 10.1016/j.amepre.2015.07.003. Epub 2015 Sep 9. PMID: 
26362405. 
81. 
Leone LA, Reuland DS, Lewis CL, Ingle M, Erman B, Summers TJ, Dubard CA, Pignone MP. Reach, 
usage, and effectiveness of a Medicaid patient navigator intervention to increase colorectal cancer 
screening, Cape Fear, North Carolina, 2011. Prev Chronic Dis. 2013 May 23;10:E82. doi: 
10.5888/pcd10.120221. PMID: 23701719; PMCID: PMC3670641. 
82. 
Ali-Faisal SF, Colella TJ, Medina-Jaudes N, Benz Scott L. The effectiveness of patient navigation to 
improve healthcare utilization outcomes: A meta-analysis of randomized controlled trials. Patient 
Educ Couns. 2017 Mar;100(3):436-448. doi: 10.1016/j.pec.2016.10.014. Epub 2016 Oct 17. PMID: 
27771161.  
83. 
Cole H, Thompson HS, White M, Browne R, Trinh-Shevrin C, Braithwaite S, Fiscella K, Boutin-Foster 
C, Ravenell J. Community-Based, Preclinical Patient Navigation for Colorectal Cancer Screening 
Among Older Black Men Recruited From Barbershops: The MISTER B Trial. Am J Public Health. 
2017 Sep;107(9):1433-1440. doi: 10.2105/AJPH.2017.303885. Epub 2017 Jul 20. PMID: 28727540; 
PMCID: PMC5551599. 

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men 
Version 1  
Protocol R44CA246899 
 
02 Oct 2025 
 
 
 
84. 
Jandorf L, Stossel LM, Cooperman JL, Graff Zivin J, Ladabaum U, Hall D, Thélémaque LD, Redd W, 
Itzkowitz SH. Cost analysis of a patient navigation system to increase screening colonoscopy 
adherence among urban minorities. Cancer. 2013 Feb 1;119(3):612-20. doi: 10.1002/cncr.27759. 
Epub 2012 Jul 25. PMID: 22833205; PMCID: PMC3492525. 
85. 
HRSA. 2019 National Health Center Data. https://data.hrsa.gov/tools/data-reporting/program-
data/national/table?tableName=Full&year=2019. Accessed December 28, 2020.  
86. 
DeGroff A, Sharma K, Satsangi A, Kenney K, Joseph D, Ross K, Leadbetter S, Helsel W, Kammerer 
W, Firth R, Rockwell T, Short W, Tangka F, Wong F, Richardson L. Increasing Colorectal Cancer 
Screening in Health Care Systems Using Evidence-Based Interventions. Prev Chronic Dis. 2018 Aug 
9;15:E100. doi: 10.5888/pcd15.180029. PMID: 30095405; PMCID: PMC6093266. 
87. 
Champion VL. Instrument development for health belief model constructs. ANS Adv Nurs Sci. 1984 
Apr;6(3):73-85. doi: 10.1097/00012272-198404000-00011. PMID: 6426380. 
88. 
Rawl SM, Skinner CS, Perkins SM, Springston J, Wang HL, Russell KM, Tong Y, Gebregziabher N, 
Krier C, Smith-Howell E, Brady-Watts T, Myers LJ, Ballard D, Rhyant B, Willis DR, Imperiale TF, 
Champion VL. Computer-delivered tailored intervention improves colon cancer screening 
knowledge and health beliefs of African-Americans. Health Educ Res. 2012 Oct;27(5):868-85. doi: 
10.1093/her/cys094. Epub 2012 Aug 27. PMID: 22926008; PMCID: PMC3442380. 
89. 
Herek GM, Gillis JR, Glunt EK, Lewis J, Welton D, Capitanio JP. Culturally sensitive AIDS educational 
videos for African American audiences: effects of source, message, receiver, and context. Am J 
Community Psychol. 1998 Oct;26(5):705-43. doi: 10.1023/a:1022157914906. PMID: 9861691. 
90. 
Matthews AK, Sánchez-Johnsen L, King A. Development of a culturally targeted smoking cessation 
intervention for African American smokers. J Community Health. 2009 Dec;34(6):480-92. doi: 
10.1007/s10900-009-9181-5. PMID: 19728056; PMCID: PMC3712791. 
91. 
Shaikh AR, Vinokur AD, Yaroch AL, Williams GC, Resnicow K. Direct and mediated effects of two 
theoretically based interventions to increase consumption of fruits and vegetables in the Healthy 
Body Healthy Spirit trial. Health Educ Behav. 2011 Oct;38(5):492-501. doi: 
10.1177/1090198110384468. Epub 2011 May 19. PMID: 21596903.