Multilevel Intervention Based on CRC and Cervical Cancer Self-screening in Rural, Segregated Areas
Phase: NA
Conditions: Colorectal Cancer Screening, Cervical Cancer Screening
Sponsor: Milton S. Hershey Medical Center

Pennsylvania State University, College of Medicine, 
Department of Family and Community Medicine Research 
Division 
Document  
Protocol 
Official 
Study Title  
Multilevel Intervention Based on Colorectal Cancer 
(CRC) and Cervical Cancer Self-Screening in Rural, 
Segregated Areas 
Document 
date 
March 1, 2021  
NCT  
04471194 
 

Page 1 of 21 (V.01/21/2019) 
HRP-591 - Protocol for  
Human Subject Research 
Protocol Title: 
Increasing cancer screening among women in rural and segregated areas: A multilevel intervention based on self-
screening and adapted educational materials 
Principal Investigator: 
Name: Jennifer Moss, PhD 
Department: Family and Community Medicine 
Telephone: 717-531-0003 x323429 
E-mail Address: jmoss1@pennstatehealth.psu.edu
Version Date: 
March 1, 2021 
Clinicaltrials.gov Registration #: 
NCT04471194 
Important Instructions for Using This Protocol Template: 
This template is provided to help investigators prepare a protocol that includes the necessary information needed by the 
IRB to determine whether a study meets all applicable criteria for approval. 
1.
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•
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protocol template version date in the footer of this document with the current version provided in the
CATS IRB Library.
•
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•
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indicate as such or skip question(s) if indicated in any of the instructional text.
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o
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section or item is not applicable, indicate not applicable.
o
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from the final version of the protocol prior to upload to CATS IRB (http://irb.psu.edu).
o
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final version of the protocol.
•
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2.
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•
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accessed by clicking the Library link in CATS IRB (http://irb.psu.edu).
3.
PROTOCOL REVISIONS:
•
When making revisions to this protocol as requested by the IRB, please follow the instructions outlined in
the Study Submission Guide available in the Help Center in CATS IRB (http://irb.psu.edu) for using track
changes.
•
Update the Version Date on page 1 each time revisions are made.

Page 2 of 21 (V.01/21/2019)  
 
 
If you need help… 
University Park and other campuses: 
Office for Research Protections Human Research 
Protection Program 
The 330 Building, Suite 205 
University Park, PA 16802-7014 
Phone: 814-865-1775 
Fax: 814-863-8699 
Email: irb-orp@psu.edu 
College of Medicine and Penn State Health: 
Human Subjects Protection Office 
90 Hope Drive, Mail Code A115, P.O. Box 855 
Hershey, PA 17033 
(Physical Office Location: Academic Support Building 
Room 1140) 
Phone: 717-531-5687 
Email: irb-hspo@psu.edu   
 
 
 
 

Page 3 of 21 (V.01/21/2019)  
Table of Contents 
1.0 
Objectives 
2.0 
Background 
3.0 
Inclusion and Exclusion Criteria 
4.0 
Recruitment Methods 
5.0 
Consent Process and Documentation 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
7.0 
Study Design and Procedures 
8.0 
Subject Numbers and Statistical Plan 
9.0 
Data and Safety Monitoring Plan 
10.0 
Risks 
11.0 
Potential Benefits to Subjects and Others 
12.0 
Sharing Results with Subjects 
13.0 
Subject Payment and/or Travel Reimbursements 
14.0 
Economic Burden to Subjects 
15.0 
Resources Available 
16.0 
Other Approvals 
17.0 
Multi-Site Study 
18.0 
Adverse Event Reporting 
19.0 
Study Monitoring, Auditing and Inspecting 
20.0 
Future Undetermined Research: Data and Specimen Banking 
21.0 
References 
22.0 
Confidentiality, Privacy and Data Management 
 
 
 

Page 4 of 21 (V.01/21/2019)  
1.0 
Objectives 
 
1.1 
Study Objectives 
In this study, we will deliver self-sampling HPV tests and FIT kits, as well as adapted cancer screening 
educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal 
cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated 
counties of Pennsylvania. A control group of 110 women, also recruited through FQHCs in rural, 
segregated counties of Pennsylvania, will be used for comparison; these women will receive standard-
of-care reminders for cancer screening and complete the baseline and follow-up surveys.  
 
The hypothesis is that delivering self-sampling HPV tests and FIT, as well as adapted educational 
materials, to women in rural, segregated areas could help overcome environment- and person-level 
barriers and thereby increase cancer screening, reduce geographic cancer disparities, and improve 
public health. 
 
1.2 
Primary Study Endpoints 
Differences in overall cervical cancer screening rate and the overall colorectal cancer screening rate at 
the end of the study between the two arms.  
2.0 
Background  
 
2.1 
Scientific Background and Gaps 
In 2018, an estimated 4,100 women in the United States died from cervical cancer, and 23,240 women 
died from colorectal cancer.1 It is possible to prevent many of these deaths through screening (e.g., with 
the human papillomavirus [HPV] test for cervical cancer or fecal immunochemical test [FIT] for 
colorectal cancer).2,3 Women ages 50-65 are eligible for routine screening for both cancers, yet 
screening for both cancers falls below national goals. Mortality and screening patterns for these cancers 
vary by geographic factors. For example, colorectal cancer mortality is 16% higher,4 and screening is 9% 
lower,5 in rural than in urban areas. Furthermore, urban/rural differences in screening may be greatest 
in areas that are also racially segregated,6 i.e., areas with high spatial concentrations of a given racial 
group. 
 
Women in areas that are both rural and segregated face unique barriers to screening for cervical and 
colorectal cancers. Social Cognitive Theory7 posits that environment-, person-, and behavior-level 
factors influence health. Interventions that target determinants at only one level fail to adequately 
address screening barriers and to account for geographic differences in behaviors.  
 
 
2.2 
Previous Data 
The principal investigator (PI) has conducted several studies on geographic disparities in cancer 
prevention and control relevant to this proposal. Most broadly, the PI published a research study 
demonstrating that, while cancer incidence is only 3% higher in rural compared to metropolitan areas, 
cancer mortality is 10% higher4; this mortality disparity increases to 13% for cervical cancer and 16% for 
colorectal cancer. Another study focused on cervical cancer described a clustering of risks for women in 
rural areas, including lower density of primary care providers, lower participation in Pap screening, and 
higher cervical cancer incidence.8 Further, the authors demonstrated that eliminating urban/rural 
differences in access to and utilization of screening would completely eliminate the disparity in 
incidence.  
 
The PI has also led research studies that incorporate other dimensions of the social environment into 
the analysis of rural cancer control (e.g., socioeconomic status, racial residential segregation). The PI has 

Page 5 of 21 (V.01/21/2019)  
a forthcoming study describing urban/rural differences in cervical and colorectal cancer screening, which 
were greatest in counties that were highly racially segregated (Moss & Landrine, in prep). In addition, an 
upcoming study describes geographic patterns in “complete” participation in cancer screening, i.e., 
receiving all of the recommended screenings for a given gender and age group (Moss & Cronin, in prep). 
The finding most relevant to this proposal is that more than 50% of women ages 45-65 living in rural and 
highly-segregated counties were out-of-date with both cervical and colorectal cancer screenings. 
Extending these findings, the PI and collaborators have demonstrated that cancer risk perceptions, 
healthcare access, and participation in cervical cancer screening were lowest in areas that were both 
rural and segregated (although colorectal cancer screening was lower in rural areas, the interaction 
between rurality and segregation did not reach statistical significance)9. 
 
Most recently, the PI has conducted several formative research studies of the target population, 
including surveys, in-depth interviews, and focus groups. These studies aimed to identify factors that 
affect cancer screening within rural, segregated counties of Pennsylvania. These studies are in the final 
phases of data collection and analysis. Preliminary results show that the target study population is 
receptive to using home cancer screening kits for both cervical and colorectal cancer (>90% willing to 
use a self-sampling test). Person- and environment-level barriers to care have been identified. Finally, 
data collected during the focus groups were used to tailor the educational materials that will be utilized 
in the proposed study.  
 
Taken together, these preliminary studies emphasize the urgent need for interventions to improve 
cervical and colorectal cancer screening behaviors in these communities. Individual-level barriers (e.g., 
attitudes) and environment-level barriers (e.g., access to care) both play an important role in explaining 
the associations of screening with rurality and racial residential segregation. 
 
2.3 
Study Rationale 
The impact of the proposed project is to improve cancer screening in vulnerable communities, 
specifically women living in rural, segregated areas of Pennsylvania through the use of home cancer 
screening kits for cervical and colorectal cancer. This will be achieved through the use of adapted 
educational materials while addressing environment- and person-level barriers to screening. 
 
For the purposes of this study, target areas are those designated as “rural” by the United States 
Department of Agriculture and with a dissimilarity index of racial residential segregation greater than 
the national mean. These counties in Pennsylvania include Clarion, Clearfield, Crawford, Forest, Greene, 
Huntingdon, Indiana, Lawrence, McKean, Northumberland, Schuylkill, Somerset, Union, and Wayne. 
3.0 
Inclusion and Exclusion Criteria 
3.1 
Inclusion Criteria 
1. Female 
2. 50-65 years of age at time of study enrollment 
3. Lives in rural, segregated county of Pennsylvania 
4. Able to speak, read, and communicate well in English 
5. Out of date for both cervical and colorectal cancer screening 
6. Active patient at selected Primary Health Network clinics 
 
3.2 
Exclusion Criteria 
1. Has had a partial or complete hysterectomy 
2. Has a family history of colorectal cancer (family member diagnosed 40 years of age or younger) 
3. Has a personal history of cervical or colorectal cancer 
4. Males 

Page 6 of 21 (V.01/21/2019)  
5. Persons who are cognitively impaired 
6. Persons who are incarcerated 
 
3.3 
Early Withdrawal of Subjects 
3.3.1 
Criteria for removal from study 
There are no foreseeable reasons why a study participant might be removed by the investigators 
from the study. Participants can voluntarily withdraw from the study at any time and for any 
reason.   
3.3.2 
Follow-up for withdrawn subjects 
The withdrawal will be documented and the subject will be replaced if the timeline allows.  
4.0 
Recruitment Methods 
4.1 
Identification of subjects 
Potentially-eligible women will be identified from the electronic health record (EHR) of partner FQHC 
clinics by an employee of the FQHC.   
 
4.2 
Recruitment process 
4.2.1 
How potential subjects will be recruited. 
Once identified via the means listed under section 4.1, an employee of the FQHC will send all 
potentially-eligible women an initial invitation letter and email to participate in the study. This initial 
invitation letter will include information from both the FQHC and the study team, and will be signed by 
both the PI and a representative of the FQHC. Included in this mailing will be directions about how to 
contact the study team if interested in study participation, and a copy of the summary explanation of 
research. The email will contain the same information as the letter, but without the summary 
explanation of research as this cannot be sent as an attached file. The email message will indicate that 
the summary explanation of research document has been included in the mailed invitation they have 
received. If the response rate is low, as assessed 6 weeks after mailing the initial invitation letter, an 
employee of the FQHC will do follow-up calls to women who were initially contacted but did not 
respond to the initial invitation letter or email.  
4.2.2 
Where potential subjects will be recruited. 
Potential participants will be recruited from participating FQHC patient populations using EHR data. 
4.2.3 
When potential subjects will be recruited. 
An employee of the FQHC will contact potentially-eligible women by mail and email using the initial 
invitation letter within one month of identification from the EHR data. Interested women will contact a 
member of the study team to express their desire to participate in the study via phone, email, the study 
website, or by completing and returning an included post card. A member of the study team will follow-
up with the potentially-eligible women by phone to screen for eligibility and complete the baseline 
survey. 
 
4.2.4 
Describe the eligibility screening process and indicate whether the screening process will 
occur before or after obtaining informed consent. Screening begins when the investigator 
obtains information about or from a prospective participant in order to determine their 
eligibility.  In some studies, these procedures may not take place unless HIPAA Authorization 
is obtained OR a waiver of HIPAA Authorization when applicable for the screening procedures 

Page 7 of 21 (V.01/21/2019)  
is approved by the IRB.  [For FDA regulated studies, consent for any screening activities would 
need to be obtained prior to screening unless specifically waived by the IRB.] 
 
A member of the study team will contact potentially-eligible women by phone to discuss the 
study, screen for eligibility, and obtain verbal consent from interested individuals.  
5.0 
Consent Process and Documentation  
5.1 
Consent Process: 
Check all applicable boxes below: 
 
 Informed consent will be sought and documented with a written consent form [Complete Sections 
5.2 and 5.6]  
 
 Implied or verbal consent will be obtained – subjects will not sign a consent form (waiver of 
written documentation of consent) [Complete Sections 5.2, 5.3 and 5.6]  
 
  Informed consent will be sought but some of the elements of informed consent will be omitted or 
altered (e.g., deception). [Complete section 5.2, 5.4 and 5.6]  
 
 Informed consent will not be obtained – request to completely waive the informed consent 
requirement. [Complete Section 5.5] 
 
 
The following checkbox is for all locations EXCEPT Penn State Health and College of Medicine:  
 
 
 Exempt Research at all Locations Except Penn State Health and the College of Medicine: If you 
believe that the research activities outlined meet one or more of the criteria outlined in “HRP-312- 
Worksheet- Exemption Determination.” Please verify by checking this box that if conducting an 
exempt research study, the consent process will disclose the following (all of which are included in 
“HRP-590- Consent Guidance for Exempt Research”): 
 
Penn State affiliation; name and contact information for the researcher and advisor (if the 
researcher is a student); the activities involve research; the procedures to be performed; 
participation is voluntary; that there are adequate provisions to maintain the privacy interests of 
subjects and the confidentiality of the data; and subjects may choose not to answer specific 
questions.   
 
 
If the research includes the use of student educational records include the following language in 
this section (otherwise delete): The parent or eligible student will provide a signed and dated 
written consent that discloses: the records that may be disclosed; the purpose of the disclosure; the 
party or class of parties to whom the disclosure may be made; if a parent or adult student requests, 
the school will provide him or her with a copy of the records disclosed; if the parent of a student 
who is not an adult so requests, the school will provide the student with a copy of the records 
disclosed. 
 
 
Note: If this box has been checked, skip the remainder of section 5 and proceed to section 6 of this 
protocol. If the investigator’s assessment is inaccurate, an IRB Analyst will request revision to the 
protocol and that an informed consent form be submitted for review and approval. Except for 
exemptions where Limited IRB Review (see “HRP-312- Worksheet- Exemption Determination”) is 
required or where otherwise requested by the IRB, informed consent forms for research activities 
determined to be exempt without Limited IRB Review are generally not required to be submitted 
for review and approval by the University Park IRB.  
 

Page 8 of 21 (V.01/21/2019)  
 
5.2 
Obtaining Informed Consent  
5.2.1 
Timing and Location of Consent  
Participants will be consented by a member of the research team over the phone, after 
eligibility is confirmed, using the Summary Explanation of Research. Participants will have 
previously received a copy of the Summary Explanation of Research in the mail with recruitment 
materials.  
5.2.2 
Coercion or Undue Influence during Consent  
After a review of the research study via the Summary Explanation of Research, participants will 
be asked if they would like to continue to participate in the baseline survey. They will be 
reminded that participation in the study will not alter or impact their care in any way. 
Participants will be reminded that they may refuse to answer any question, and may end their 
participation at any time. 
 
5.3 
Waiver of Written Documentation of Consent  
5.3.1 
Indicate which of the following conditions applies to this research: 
  The research presents no more that minimal risk of harm to subjects and involves no 
procedures for which written consent is normally required outside of the research context. 
OR 
  The only record linking the subject and the research would be the consent document and the 
principal risk would be potential harm resulting from a breach of confidentiality. Each subject 
will be asked whether the subject wants documentation linking the subject with the research, 
and the subject’s wishes will govern. (Note: This condition is not applicable for FDA-regulated 
research. If this category is chosen, include copies of a consent form and /or parental 
permission form for participants who want written documentation linking them to the 
research.) 
OR 
  If the subjects or legally authorized representatives are members of a distinct cultural group 
or community in which signing forms is not the norm, that the research presents no more 
than minimal risk of harm to subjects and provided there is an appropriate alternative 
mechanism for documenting that informed consent was obtained.  (Note: This condition is not 
applicable for FDA-regulated research.)  
 
Describe the alternative mechanism for documenting that informed consent was obtained: 
5.3.2 
Indicate what materials, if any, will be used to inform potential subjects about the research 
(e.g., a letter accompanying a questionnaire, verbal script, implied consent form, or summary 
explanation of the research) 
 
Potential participants identified via the means outlined in section 4.1 will receive the initial 
invitation letter, initial invitation email, and the initial invitation post card inviting them to 
participate in the research. These documents will direct them to the study team website 
(research.med.psu.edu/casper). The FQHC recruitment script will be used to as a secondary 
means of recruitment, if necessary. The summary explanation of research will be sent to 
participants with the mailed recruitment materials. 

Page 9 of 21 (V.01/21/2019)  
5.4 
Informed consent will be sought but some of the elements of informed consent will be omitted or 
altered (e.g., deception). 
5.4.1 
Indicate the elements of informed consent to be omitted or altered 
Not applicable. 
5.4.2 
Indicate why the research could not practicably be carried out without the omission or 
alteration of consent elements 
Not applicable. 
5.4.3 
Describe why the research involves no more than minimal risk to subjects. 
Not applicable. 
5.4.4 
Describe why the alteration/omission will not adversely affect the rights and welfare of 
subjects. 
Not applicable. 
5.4.5 
If the research involves using identifiable private information or identifiable biospecimens, 
describe why the research could not be practicably be carried out without using such 
information or biospecimens in an identifiable format. 
Not applicable. 
5.4.6 
Debriefing  
Not applicable. 
5.5 
Informed consent will not be obtained – request to completely waive the informed consent 
requirement 
5.5.1 
Indicate why the research could not practicably be carried out without the waiver of consent 
Not applicable. 
5.5.2 
Describe why the research involves no more than minimal risk to subjects. 
Not applicable. 
5.5.3 
Describe why the alteration/omission will not adversely affect the rights and welfare of 
subjects. 
Not applicable. 
5.5.4 
If the research involves using identifiable private information or identifiable biospecimens, 
describe why the research could not be practicably be carried out without using such 
information or biospecimens in an identifiable format. 
Not applicable. 
5.5.5 
Additional pertinent information after participation 
Not applicable. 
 
 
5.6 
Consent – Other Considerations  
 
5.6.1 
Non-English-Speaking Subjects 
Not applicable. 
 

Page 10 of 21 (V.01/21/2019)  
5.6.2 
Cognitively Impaired Adults 
 
5.6.2.1 Capability of Providing Consent 
Not applicable. 
 
5.6.2.2 Adults Unable to Consent 
Not applicable. 
 
5.6.2.3 Assent of Adults Unable to Consent 
Not applicable. 
 
5.6.3 
Subjects who are not yet adults (infants, children, teenagers)  
 
5.6.3.1 Parental Permission 
Not applicable. 
 
5.6.3.2 Assent of subjects who are not yet adults 
Not applicable. 
 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
 
6.1 
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
Check all that apply: 
  
Not applicable, no identifiable protected health information (PHI) is accessed, used or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable] 
 
 
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable] 
 
 
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3] 
 
 
Full waiver is requested for entire research study (e.g., medical record review studies). 
[Complete all parts of sections 6.2 and 6.3] 
 
 
Alteration is requested to waive requirement for written documentation of authorization 
(verbal authorization will be obtained). [Complete all parts of sections 6.2 and 6.3] 
 
6.2 
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
6.2.1 
Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the 
individual 
6.2.1.1 
Plan to protect PHI from improper use or disclosure 
Information is included in the “Confidentiality, Privacy and Data 
Management” section of this protocol. 
 

Page 11 of 21 (V.01/21/2019)  
6.2.1.2 
Plan to destroy identifiers or a justification for retaining identifiers  
Identifying information will be destroyed after the completion of data 
analysis. 
 
6.2.2 
Explanation for why the research could not practicably be conducted without access to and 
use of PHI 
 
PHI is necessary for processing the self-sampling tests. Participant date of birth is required when 
completing the Pathology Services Special Account Requisition form. Thus, the research 
question regarding completion of self-sampling tests cannot be answered without use of PHI. 
Additionally, participant address and email address is necessary for mailing study materials and 
compensation. 
 
6.2.3 
Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization 
 
Alteration of authorization is necessary since participants will be giving hipaa authorization via 
verbal consent, over the phone prior to data collection. All data collection for the proposed 
study will be conducted over the phone; written consent is not feasible since none of the study 
activities will not be in person. 
 
6.3 
Waiver or alteration of authorization statements of agreement 
 
Protected health information obtained as part of this research will not be reused or disclosed to any other 
person or entity, except as required by law, for authorized oversight of the research study, or for other 
permitted uses and disclosures according to federal regulations.  
 
The research team will collect only information essential to the study and in accord with the ‘Minimum 
Necessary’ standard (information reasonably necessary to accomplish the objectives of the research) per 
federal regulations.  
 
Access to the information will be limited, to the greatest extent possible, within the research team. All 
disclosures or releases of identifiable information granted under this waiver will be accounted for and 
documented. 
 
7.0 
Study Design and Procedures 
 
 
7.1 
Study Design 
The study is a prospective, two-arm, randomized intervention. Participants will be randomized to 
receive either (1) a standardized letter informing them that they are out-of-date for both cervical and 
colorectal cancer screenings and should schedule an appointment with their provider to receive these 
screenings, i.e., standard of care (control arm), or (2) cervical and colorectal cancer self-sampling kits, 
instructions for completing the self-sampling kits, and educational materials about cervical and 
colorectal cancer (intervention arm). Participants in the intervention arm will mail their completed self-
sampling kits to the Penn State Health Clinical Labs for processing; FIT kits will then be sent to and 
processed by Quest diagnostics. All participants will complete a baseline and follow-up survey. 
 
7.2 
Study Procedures 
 

Page 12 of 21 (V.01/21/2019)  
7.2.1 
Baseline survey- Week 0 
 
Once a participant has been identified, recruited, and consented as described above, she will 
complete the baseline survey with a member of the study team via phone. After completion of 
the baseline survey, the participant will receive a thank you letter from the study team. 
 
7.2.2 
Randomization- Week 0 
 
Once a participant has completed the baseline survey, she will be randomly assigned to either 
the control arm or the intervention arm by a member of the study team. A simple 
randomization scheme, with 1:1 randomization, will be used to ensure equal sample sizes in the 
intervention and control arms.  
 
 
7.2.3 
Control arm- Week 1 
 
Participants randomized into the control arm will be mailed a standardized letter informing 
them that they are out-of-date for both cervical and colorectal cancer screenings and should 
schedule an appointment with their provider to receive these screenings.  
 
7.2.4 
Intervention arm- Week 1 
 
Participants randomized into the intervention arm will be mailed cervical and colorectal cancer 
self-sampling kits, instructions for completing the self-sampling kits, a lab requisition form, and 
educational materials about cervical and colorectal cancer. Participants will also receive an 
intervention cover letter that describes the contents of the package and what they are being 
asked to do. Participants will be asked to complete both cervical and colorectal cancer self-
sampling kits within 3 days of each other via the intervention cover letter. Once complete, 
participants will mail the kits within 3 days of completing both tests to the Penn State Hershey 
Clinical Labs in a prepaid mailer provided by the study team. Notably, deviations from the timing 
of sampling and returning the test kits is quite flexible, since studies show that these samples 
are stable for up to 28 days.  
 
 
7.2.4.1 
Reminder postcard- Week 6 
 
Participants who have not completed and returned both their cervical and colorectal 
cancer self-sampling kits within 6 weeks of receipt of kits will be mailed a reminder 
letter from the study team. 
 
7.2.5 
Follow-up survey- Week 10 
 
Participants will complete the follow-up survey with a member of the study team via phone. 
This will occur regardless of whether the participant was in the intervention or the control arm, 
and regardless of whether the participant completed and returned the self-sampling kits if in the 
intervention arm.  
 
 
7.3 
Duration of Participation 
 
Participants will be considered enrolled in the study from the time of consent until the completion of 
the follow-up survey. We anticipate a total participation of approximately 1 hour and 35 minutes for 
those in the intervention arm over the course of 10 weeks; this includes ~45 minutes to complete the 
baseline survey, ~20 minutes for the follow-up survey and up to ~15 minutes to complete each cervical 

Page 13 of 21 (V.01/21/2019)  
and colorectal cancer screening test kits. We anticipate a total participation of approximately 1 hour and 
5 minutes for those in the control arm, over the course of 10 weeks; this includes ~45 minutes to 
complete the baseline survey and ~20 minutes for the follow-up survey.  
 
7.4 
Test Article(s) (Study Drug(s) and/or Study Device(s)) 
7.4.1 
Description 
The Evalyn® Brush is a self-sampling kit that screens for HPV, a leading cause of cancer death 
among women. This tool has recently been FDA approved, but has not been incorporated into 
national clinical guidelines. This product is a small pink capped brush that can be used to take a 
sample of cervical cells.  
 
The InSure® test (Fecal Globin by Immunochemistry) is a fecal occult blood test that detects 
human hemoglobin from blood in fecal samples. The test is recommended for use by healthcare 
professionals to screen for colorectal cancer.  
7.4.2 
Treatment Regimen 
Participants will take a sample of their cervix cells that amounts to a few millimeters of bio 
specimen. 
 
Participants will collect a fecal sample from toilet water using the provided tools and brush the 
sample on the InSure® FOBT test card. 
7.4.3 
Method for Assigning Subject to Treatment Groups 
Once a participant has completed the baseline survey, she will be randomly assigned to either 
the control arm or the intervention arm by a member of the study team. A simple 
randomization scheme, with 1:1 randomization, will be used to ensure equal sample sizes in the 
intervention and control arms.  
7.4.4 
Subject Compliance Monitoring 
Subject compliance will be confirmed once their lab results are received from the Penn State 
Heath Clinical lab.  
7.4.5 
Blinding of the Test Articles 
Not applicable. 
7.4.6 
Receiving, Storage, Dispensing and Return  
 
7.4.6.1 
Receipt of Test Article  
HPV self-sampling kits (Evalyn Brush, Rovers Medical Devices) are purchased 
from the manufacturer and shipped to the PI’s office at Penn State Health. 
The study test article will be mailed to each participant in the intervention 
arm in original, unopened packaging, including 1 brush, 1 protective cap, 1 
container/package for the brush, and 1 plastic bag for return mailing. The 
mailing will also include a lab requisition form (including a unique 
participant ID) to link each participant with their returned test kit. 
 
FIT kits (InSure test, Fecal Globin by Immunochemistry) are purchased 
through Quest Diagnostics and shipped to the PI’s office at Penn State 
Health. The study test article will be mailed to each participant in the 
intervention arm in original, unopened packaging, including 1 sample card, 1 

Page 14 of 21 (V.01/21/2019)  
collection brush, 1 self-adhesive label, and 1 reply form. The mailing will 
also include a lab requisition form (including a unique participant ID) to link 
each participant with their returned test kit. 
 
The mailing will also include a pre-stamped and pre-addressed return 
shipping container for the participant to use to mail both kits to the PSH 
Clinical Lab. The unique participant ID will also be printed on this envelope 
and other participant materials.  
 
7.4.6.2 
Storage 
Before HPV self-sampling kits are sent to study participants, they will be 
stored in a locked cabinet in the Department of Family and Community 
Medicine offices at 134 Sipe Ave. Kits mailed to the lab will be disposed of 
after analysis.  
 
Before colorectal self-sampling kits are sent to study participants, they will 
be stored in a locked cabinet in the Department of Family and Community 
Medicine offices at 134 Sipe Ave. Kits mailed to the lab will be disposed of 
after analysis.  
 
7.4.6.3 
Preparation and Dispensing 
Before it is sent to the participant, the Penn State Heath Clinical lab 
Pathology Services Special Account Requisition documents will be labeled 
with the participant’s study ID #, date of birth, and sex (as required by the 
Requisition form). The mailing will include the HPV self-sampling kit with 
the instructions, the colorectal cancer self-sampling kit with the 
instructions, a Penn State Heath Clinical lab Pathology Services Special 
Account Requisition form, educational materials regarding the use of home 
cancer screening kits, and an intervention cover letter.  
 
The package will also include a prepaid and labeled mailing to send the kits 
and Pathology Services Special Account Requisition documents to the Penn 
State Heath Clinical lab. Participants will need to include the date and time 
of sample collection on the requisition form. 
 
7.4.6.4 
Return or Destruction of the Test Article 
HPV self-sampling kits will not be returned to participants. The samples will 
be analyzed and the kits will be destroyed by the Penn State Heath Clinical 
lab once analysis is complete. 
 
Colorectal cancer self-sampling kits will not be returned to participants. 
The samples will be analyzed and the kits will be destroyed by the Quest 
Diagnostics once analysis is complete. 
 
7.4.6.5 
Prior and Concomitant Therapy 
Not applicable. 
 
8.0 
Subject Numbers and Statistical Plan 
 

Page 15 of 21 (V.01/21/2019)  
8.1 
Number of Subjects 
We plan to contact 500 potentially-eligible women via mail and email using the initial invitation letter. 
Of these, 220 are planned to consent and complete the baseline survey. From this 220, 110 will be 
randomized to the control group and 110 will be randomized to the intervention group. We expect 
about 10% loss to follow-up over the study period. 
 
8.2 
Sample size determination 
This is a pilot study to approximate the rates of colorectal and cervical screening in the two study arms. 
Should the intervention yield a screening rate of 40% and the control arm a screening rate of 20%, then 
the proposed sample sizes yield 80% power based on a two-sided Fisher’s exact test and a 2.5% type-1 
error rate (allowing for two co-primary endpoints). The results of this pilot study will inform us with 
more accurate assessments of these screening rates so that future, more accurately powered studies 
can be conducted. 
 
8.3 
Statistical methods 
The statistical analysis of study outcomes will primarily be descriptive. Outcomes will be assessed via the 
baseline and follow-up surveys, and whether or not self-sampling kits were returned by participants in 
the intervention arm. The main outcome is the differences in overall cervical cancer screening rate and 
the overall colorectal cancer screening rate at the end of the study between the two arms. Analysis of 
the main outcomes will be evaluated with a Fisher’s exact test.  Demographics of the patients in the two 
groups will be compared. 
9.0 
Data and Safety Monitoring Plan 
9.1 
Periodic evaluation of data 
Not applicable.  
 
9.2 
Data that are reviewed 
Not applicable.  
9.3 
Method of collection of safety information 
Not applicable.  
9.4 
Frequency of data collection 
Not applicable.  
9.5 
Individuals reviewing the data 
Not applicable.  
9.6 
Frequency of review of cumulative data 
Not applicable. 
9.7 
Statistical tests 
Not applicable.  
9.8 
Suspension of research 
Not applicable.  
 

Page 16 of 21 (V.01/21/2019)  
10.0 Risks 
The greatest potential risk to participants is psychological harm of cancer screening. Some participants may 
experience anxiety while collecting the screening samples or awaiting screening results. Studies have 
demonstrated that this anxiety is transient10. Financial, legal, or other risks are not anticipated. 
 
For participants who complete the self-sampling test for cervical cancer, there is a risk of minor internal damage 
that may occur when collecting the sample. The minor internal damage is transient and resolves itself. There are 
no foreseeable physical risks for completing the self-sampling test for colorectal cancer. For participants who 
screen positive on HPV test or FIT, additional risks are possible. Among 100 participants ages 50-65, we anticipate 
that up to 6 will screen positive on the HPV test 11 and up to 4 will screen positive on the FIT12. 
 
For participants with abnormal results on their screening tests, test results will be communicated to the 
participant via their medical provider at the FQHC following the standard of care, including encouraging her to 
seek follow-up care (e.g., additional screenings) at the FQHC or elsewhere. In addition, educational materials 
mailed to those in the intervention group will include recommended follow-up steps for women who receive 
abnormal results, specifically, seeking additional screening or diagnostic tests. These materials will encourage 
participants to reach out to their medical provider at the FQHCs for these tests (or for referral to specialists). Test 
results will be mailed to both the study team and the participating FQHC to ensure proper follow-up. These 
procedures should minimize the time it takes for participants to seek follow-up for abnormal screening results, 
therefore lowering the potential risks from an abnormal screening result. Should any participants be diagnosed 
with cervical or colorectal cancer, potential treatments for individuals with screen-detected versus symptomatic 
cancers are theoretically less risky. 
 
Loss of confidentiality is a risk of participation. Disclosure of responses to survey items will not place participants 
at risk of criminal or civil liability or be damaging to their finances, employability, or reputation. 
 
Protection against risks. 
To protect against psychological risks associated with cancer screening, we will include information in the 
educational materials about (1) what screening tests examine, (2) what potential abnormal results could indicate, 
and (3) recommendations for follow-up after abnormal results. 
 
In order to protect participant privacy (including survey responses and results of cancer screening tests), data will 
be maintained on a password-protected database on a secure network. A password-protected dataset containing 
participant identifying information will also be maintained on the secure network, but only the study team will 
have access to this dataset; this dataset will be destroyed after the study is complete.  
 
11.0 Potential Benefits to Subjects and Others  
11.1 
Potential Benefits to Subjects 
No direct benefits to subjects. 
11.2 
Potential Benefits to Others 
The findings of this study can provide benefits to others in that they will inform future interventions, 
public health programs, and clinical practice to promote screening, earlier diagnosis, and increased 
survival of cervical and colorectal cancer, especially in vulnerable communities. In addition, the 
proposed research will benefit participants and others by contributing to scientific knowledge about the 
fields of health behaviors and cancer prevention. This knowledge has implications for improving clinical 
and public health generally, as well as specifically increasing cancer screening and, in the long-term, 
reducing disparities in, and the overall burden of, cervical and colorectal cancers. 

Page 17 of 21 (V.01/21/2019)  
12.0 Sharing Results with Subjects 
Study findings will not be directly shared with participants by the study team. However, participants will be notified of 
their self-sampling results by their medical provider at the FQHC. Research study team members will receive the results 
of the self-sampling kit from the lab and communicate these results to a central administrative employee at the FQHC 
via Penn State Kiteworks. This individual will share the results with the participants’ medical provider at the FQHC. The 
medical provider will then share these results with the participants via the standard of care as determined by the 
provider. PHN’s policy regarding sharing test results with patients is as follows: 
 Once the results are received, the ordering providers must personally acknowledge receipt of the results with a 
signature and date and indicated if further action is needed. 
 
a. Depending on the type of the test result, the ordering providers may communicate results to the patients or may 
request that a clinical staff member contact the patient with results and any follow-up instructions. All patient 
communication is to be documented in the EMR. 
b. When the patient must take action in response to the results, direct verbal communication should be used. 
Documentation should reflect that the information was received and understood by the patient. If the patient cannot be 
reached, reasonable attempts should be made, this includes using phone outreach and mailed letter attempts. All 
attempts should be documented in the medical record. 
 
For abnormal results: 
1. An attempt to communicate results to the patient must be initiated within 14 days of receiving results. Follow up 
instructions should be provided via verbal communication. 
2. If the patient is not able to reached in person or by phone, a standard ‘test result’ letter found in our EMR, indicating 
the need for the patient to contact the office will be mailed to the patient. 
 
13.0 Subject Payment and/or Travel Reimbursements 
The study team has received an exception from using Greenphire ClinCards from the Controller. Physical or 
electronic retailer gift cards to reimburse participants will be purchased through Shop OnLion. 
 
Subjects will receive a total of $50 in Walmart gift cards for their participation. A $20 Walmart gift card will be 
provided upon completion of the baseline survey and a $30 Walmart gift card will be provided upon completion 
of the follow-up survey, regardless of whether the self-sampling kits are returned. All gift cards will be electronic 
unless a physical gift card is requested by the participant. 
14.0 Economic Burden to Subjects 
14.1 
Costs 
There are no costs that subjects may be responsible for because of participation in this research. All 
necessary costs will be covered by the research study. 
 
14.2 
Compensation for research-related injury 
Not applicable.  
15.0 Resources Available  
 
15.1 
Facilities and locations 
Participants will be recruited through collaborating FQHCs in eligible counties. These counties include: 
Crawford, Lawrence, Greene, Forest, Clarion, McKean, Clearfield, Indiana, Somerset, Huntingdon, Union, 
Northumberland, Schuylkill, and Wayne. FQHCs have been identified by the Pennsylvania Association of 
Community Health Centers. A letter of support that states participating clinic locations, provided by the 
partner FQHC, is available for review in the attached letters of agreement.  

Page 18 of 21 (V.01/21/2019)  
15.2 
Feasibility of recruiting the required number of subjects 
Community Health Centers see thousands of patients annually. Our partner FQHC sees close to 85,000 
patients annually across all clinics, and sees roughly 1,800 women in our target population (women ages 
50-65) at participating clinics. We seek to recruit 220 members of this target population. 
15.3 
PI Time devoted to conducting the research 
The PI will utilize dedicated research time to conduct this research. 
15.4 
Availability of medical or psychological resources 
Any participant requiring medical or psychological resources as a result of participating in this study will 
be referred to the Primary Health Network clinic where they receive care. These resources might include 
follow-up procedures or any other preventive/screening services they need.” 
15.5 
Process for informing Study Team 
The research team will meet regularly to discuss this study, study procedures, and any issues that may 
arise. All team members will receive in-depth protocol training before performing any study-related 
tasks. 
16.0 Other Approvals 
16.1 
Other Approvals from External Entities 
This research proposal has been reviewed by the National Institutes of Health, which is the funding 
agency for the study, during the grant review process. Each FQHC has provided approvals to confirm 
their participation in this study as noted in the attached letters of agreement. 
16.2 
Internal PSU Committee Approvals 
 
Check all that apply: 
  Anatomic Pathology – Penn State Health only – Research involves the collection of tissues or use of 
pathologic specimens. Upload a copy of “HRP-902 - Human Tissue For Research Form” in CATS IRB.  
 
  Animal Care and Use – All campuses – Human research involves animals and humans or the use of 
human tissues in animals 
 
  Biosafety – All campuses – Research involves biohazardous materials (human biological specimens 
in a PSU research lab, biological toxins, carcinogens, infectious agents, recombinant viruses or DNA 
or gene therapy). 
 
  Clinical Laboratories – Penn State Health only – Collection, processing and/or storage of extra tubes 
of body fluid specimens for research purposes by the Clinical Laboratories; and/or use of body fluids 
that had been collected for clinical purposes but are no longer needed for clinical use. Upload a copy 
of “HRP-901 - Human Body Fluids for Research Form” in CATS IRB.  
 
  Clinical Research Center (CRC) Advisory Committee – All campuses – Research involves the use of 
CRC services in any way. 
 
  Conflict of Interest Review – All campuses – Research has one or more of study team members 
indicated as having a financial interest. 
 

Page 19 of 21 (V.01/21/2019)  
  Radiation Safety – Penn State Health only – Research involves research-related radiation 
procedures. All research involving radiation procedures (standard of care and/or research-related) 
must upload a copy of “HRP-903 - Radiation Review Form” in CATS IRB.  
 
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or IDE or 
intends to hold the IND or IDE. 
 
  Scientific Review – Penn State Health only – All investigator-written research studies requiring 
review by the convened IRB must provide documentation of scientific review with the IRB 
submission. The scientific review requirement may be fulfilled by one of the following: (1) external 
peer-review process; (2) department/institute scientific review committee; or (3) scientific review by 
the Clinical Research Center Advisory committee.  NOTE: Review by the Penn State Health Cancer 
Institute (PSCI) Protocol Review Committee or the PSCI Disease Team is required if the study 
involves cancer prevention studies or cancer patients, records and/or tissues. For more information 
about this requirement see the IRB website. 
 
17.0 Multi-Site Study 
 
17.1 
Other sites  
 
 
Not applicable.  
 
17.2 
Communication Plans 
Not applicable. 
 
17.3 
Data Submission and Security Plan 
Not applicable. 
 
17.4 
Subject Enrollment 
Not applicable. 
 
17.5 
Reporting of Adverse Events and New Information 
Not applicable. 
 
17.6 
Audit and Monitoring Plans 
Not applicable.  
18.0 Adverse Event Reporting 
18.1 
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB 
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) experienced 
by a subject or other individual, which in the opinion of the investigator is determined to be (1) 
unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures. 
19.0 Study Monitoring, Auditing and Inspecting 
 
19.1 
Auditing and Inspecting 
The investigator will permit study-related monitoring, audits, and inspections by the Penn State quality 
assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related 

Page 20 of 21 (V.01/21/2019)  
documents (e.g., source documents, regulatory documents, data collection instruments, study data etc.).  
The investigator will ensure the capability for inspections of applicable study-related facilities (e.g., 
pharmacy, diagnostic laboratory, etc.). 
20.0 Future Undetermined Research: Data and Specimen Banking 
20.1 
Data and/or specimens being stored 
Not applicable. 
 
20.2 
Location of storage 
Not applicable. 
 
20.3 
Duration of storage 
Not applicable. 
 
20.4 
Access to data and/or specimens 
Not applicable. 
 
20.5 
Procedures to release data or specimens 
Not applicable. 
 
20.6 
Process for returning results 
Not applicable. 
21.0 References 
 
1 
Siegel, R. L., Miller, K. D. & Jemal, A. Cancer statistics, 2018. CA Cancer J Clin 68, 7-30, doi:10.3322/caac.21442 (2018). 
2 
U. S. Preventive Services Task Force. Final recommendation statement: Cervical cancer: Screening, 
<https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/cervical-cancer-
screening2> (2018). 
3 
U. S. Preventive Services Task Force. Final recommendation statement: Colorectal cancer: Screening, 
<https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/colorectal-cancer-
screening2> (2016). 
4 
Blake, K. D., Moss, J. L., Gaysynsky, A., Srinivasan, S. & Croyle, R. T. Making the case for investment in rural cancer 
control: An analysis of rural cancer incidence, mortality, and funding trends. Cancer Epidemiol Biomarkers Prev (2017). 
5 
Cole, A. M., Jackson, J. E. & Doescher, M. Urban–rural disparities in colorectal cancer screening: cross‐sectional analysis of 
1998–2005 data from the Centers for Disease Control's Behavioral Risk Factor Surveillance Study. Cancer medicine 1, 350-
356 (2012). 
6 
Coughlin, S. S., King, J., Richards, T. B. & Ekwueme, D. U. Cervical cancer screening among women in metropolitan areas 
of the United States by individual-level and area-based measures of socioeconomic status, 2000 to 2002. Cancer 
epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by 
the American Society of Preventive Oncology 15, 2154-2159, doi:15/11/2154 [pii] (2006). 
7 
Bandura, A. Social cognitive theory. Handbook of social psychological theories, 349-373 (2011). 
8 
Moss, J. L., Liu, B. & Feuer, E. J. Urban/Rural Differences in Breast and Cervical Cancer Incidence: The Mediating Roles of 
Socioeconomic Status and Provider Density. Womens Health Issues 27, 683-691, doi:10.1016/j.whi.2017.09.008 (2017). 
9 
Moss, J. L., Ehrenkranz, R., Perez, L. G., Hair, B. Y. & Julian, A. K. Geographic disparities in cancer screening and fatalism 
among a nationally representative sample of US adults. J Epidemiol Community Health 73, 1128-1135, doi:10.1136/jech-
2019-212425 (2019). 
10 
Wardle, J. et al. Psychological impact of colorectal cancer screening. Health Psychol 22, 54-59, doi:10.1037//0278-
6133.22.1.54 (2003). 
11 
Datta, S. D. et al. Human papillomavirus infection and cervical cytology in women screened for cervical cancer in the United 
States, 2003-2005. Ann Intern Med 148, 493-500, doi:10.7326/0003-4819-148-7-200804010-00004 (2008). 
12 
Shin, H. Y. et al. Performance of the Fecal Immunochemical Test for Colorectal Cancer Screening Using Different Stool-
Collection Devices: Preliminary Results from a Randomized Controlled Trial. Gut Liver 10, 925-931, doi:10.5009/gnl15479 
(2016). 

Page 21 of 21 (V.01/21/2019)  
22.0  Confidentiality, Privacy and Data Management  
IMPORTANT: The following section is required for all locations EXCEPT Penn State Health and the College of 
Medicine.  Penn State Health and College of Medicine should skip this section and complete “HRP-598 
Research Data Plan Review Form.” In order to avoid redundancy, for this section state “See the Research Data 
Plan Review Form” if you are conducting Penn State Health research. Delete all other sub-sections of section 
22. 
 
See the Research Data Plan Review Form.