Testing a Low Cost Population- and Theory-Based Outreach Intervention to Engage Ovarian Cancer Survivors and Their Close Relatives to Consider Genetic Services
Phase: NA
Conditions: Ovarian Cancer
Sponsor: Emory University

Study Protocol 
 
Title: Testing a Low Cost Population- and Theory-Based Outreach 
Intervention to Engage Ovarian Cancer Survivors and Their Close 
Relatives to Consider Genetic Services 
 
NCT Number: NCT04927013 
 
Protocol date: October 3, 2022 

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Engage Ovarian Cancer Survivors and their Close Relatives to Consider Genetic Services.
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PROTOCOL TITLE:   Testing a Low Cost Population- and Theory-Based Outreach Intervention to 
Engage Ovarian Cancer Survivors and their Close Relatives to Consider Genetic Services.
PRINCIPAL INVESTIGATOR:
Colleen M. McBride, Ph.D.
Grace Crum Rollins Professor and Chair
Behavioral Sciences and Health Education Department
Rollins School of Public Health
Emory University
Phone: 404-727-8226
Email: cmmcbri@emory.edu
EXTERNAL (NON-EMORY) COLLABORATORS N/A ☐:                                                                    
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FUNDING SOURCE: National Cancer Institute, U01CA240581.

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REVISION HISTORY
Revision #
Version 
Date
Summary of Changes

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Table of Contents
1.0
Study Summary....................................................................................................................5
2.0
Objectives* ..........................................................................................................................5
3.0
Background*........................................................................................................................5
4.0
Study Endpoints*.................................................................................................................5
5.0
Study Intervention / Design.................................................................................................6
6.0
Procedures Involved* ..........................................................................................................6
7.0
Data and Specimen Banking* ..............................................................................................6
8.0
Sharing of Results with Participants* ..................................................................................7
9.0
Study Timelines*..................................................................................................................7
10.0
Subject Population*.............................................................................................................7
11.0
Vulnerable Populations* .....................................................................................................8
12.0
Local Number of Participants ..............................................................................................8
13.0
Recruitment Methods..........................................................................................................8
14.0
Withdrawal of Participants*................................................................................................9
15.0
Risks to Participants*...........................................................................................................9
16.0
Potential Benefits to Participants*......................................................................................9
17.0
Data Analysis, Management* and Confidentiality.............................................................10
18.0
Provisions to Monitor the Data to Ensure the Safety of Participants*..............................10
19.0
Provisions to Protect the Privacy Interests of Participants and Confidentiality of 
Participants’ identifiable data.......................................................................................................11
20.0
Compensation for Research-Related Injury.......................................................................11
21.0
Economic Burden to Participants ......................................................................................11
22.0
Consent Process.................................................................................................................12
23.0
Process to Document Consent in Writing..........................................................................15
24.0
Setting................................................................................................................................15
25.0
Resources Available...........................................................................................................16
26.0
Multi-Site Research*  ....................................................................................................16
27.0
References.........................................................................................................................17

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1.0
Study Summary
Study Title
Testing a Low Cost Population- and Theory-Based 
Outreach Intervention to Engage Ovarian Cancer 
Survivors and their Close Relatives to Consider Genetic 
Services
Study Design
randomized intervention trial
Primary Objective
Aim 1: To enlist community partners as citizen 
scientists to: identify and recruit Georgia residents 
with a personal/family history of ovarian cancer, 
generate content, and collaborate on a scalable 
message-based outreach intervention to reach 
ovarian cancer survivors and close relatives (i.e., first- 
and second-degree relatives) to consider genetic 
service options. 
Aim 2: In a two-arm randomized intervention trial 
(RCT), to compare a message-based outreach 
intervention to standard outreach for effects on: 
survivor reach, relative reach, and uptake of 
appropriate cancer genetic services (i.e., genetic 
counseling and testing for survivors, online genetic 
risk assessment for relatives) among survivors of 
ovarian cancer identified via a state cancer registry. 
We hypothesize that the message-based approach will 
result in greater reach and uptake of genetic services 
than standard outreach.
Aim 3: To conduct a process evaluation consistent 
with the RE-AIM framework alongside the RCT to 
measure: reactions, dose delivered/received, fidelity, 
acceptability, barriers/facilitators, and alignment with 
ethical principles.
Secondary Objective(s)
N/A
Research 
Intervention(s)/Interactions
A message-based outreach intervention
Study Population
Georgia residents with a personal or family history of 
ovarian cancer
Sample Size
1,240
Study Duration for 
individual participants
Study duration varies for different participants.
Aim 
1 
(community 
working 
groups): 
Eligible 
participants are: English-speaking, have a personal 

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and/or family history of ovarian cancer, 25 years or 
older, have access to the internet and be available to 
attend in-person or online focus group discussions. 
Participants will attend 2 to 3 90-minute in-person 
meetings and some additional outside “homework”.
Aim 2 (message-based intervention (MBI) and waitlist 
standard outreach approaches): Eligible survivors are: 
diagnosed with ovarian, fallopian tube, or peritoneal 
cancers, lived in Georgia at the time of diagnosis, not 
deceased, and have a mailing address per the Georgia 
Cancer Registry (GCR)’s records. Study duration could 
to up to one year. 
Aim 2 & 3 (post-intervention online survey): Survivors 
and relatives in both arms who login to the study 
website will be invited to complete an one-time online 
survey. Study duration could to up to 30 min.
Aim 3 (mail survey to survivors who did not login to 
the study website): GCR will send a brief survey with a 
$10 incentive to survivors who do not visit the website 
after the third and final mailing. Study duration could 
to up to 10 min.
Aim 3 (online discussion forum): We propose to 
purposefully sample survivors (~25) and relatives (~25) 
randomized to the MBI arm to participate in an online 
discussion forum. Study duration could to up to 1 hour.
Aim 3 (re-engagement of working groups, Year 4): 
After data analysis is complete (late Year 4), we will 
reengage community working groups from Aim 1 for a 
half-day workshop where we will report findings of the 
intervention and enlist additional feedback. 
Study Specific 
Abbreviations/ Definitions 
Georgia Cancer Registry (GCR); Randomized control 
trial (RCT); Community advisory boards (CABs)
Funding Source (if any)
National Cancer Institute, pending council review
2.0
Objectives*
2.1
Aim 1: To enlist community partners as citizen scientists to: identify and 
recruit Georgia residents with a personal/family history of ovarian cancer, 
generate content, and collaborate on a scalable message-based outreach 
intervention to reach ovarian cancer survivors and close relatives (i.e., first- and 
second-degree relatives) to consider genetic service options. 

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Aim 2: In a two-arm randomized intervention trial (RCT, N~2,918), to compare a 
message-based outreach intervention to standard outreach for effects on: 
survivor reach, relative reach, and uptake of appropriate cancer genetic services 
(i.e., genetic counseling and testing for survivors, online genetic risk assessment 
for relatives) among survivors of ovarian cancer identified via a state cancer 
registry. 
Aim 3: To conduct a process evaluation consistent with the RE-AIM framework 
alongside the RCT to measure: reactions, dose delivered/received, fidelity, 
acceptability, barriers/facilitators, and alignment with ethical principles.
2.2
We hypothesize that the message-based approach will result in greater 
reach and uptake of genetic services than standard outreach.
3.0
Background*
The majority of women at greatest risk for ovarian cancer due to hereditary 
factors are unlikely to know about their elevated risk and prevention 
opportunities. This significant gap in outreach means that most at-risk women 
will receive a late diagnosis of ovarian cancer with a dramatic negative effect on 
survival.1 Traceback approaches that leverage state-wide cancer registries’ 
ongoing surveillance activities offer a potentially low cost platform for outreach 
to ovarian cancer survivors and their close relatives. 
Approximately 15-20% of epithelial ovarian cancers are due to inherited 
mutations in cancer predisposing genes.2 As such, it is now routine in specialty 
cancer care settings to offer genetic counseling and testing to all patients 
diagnosed with ovarian cancer.3,4 To promote cascade testing, patients 
identified with deleterious mutations are generally sent notification letters, and 
informational materials for specific relatives recommending that relatives seek 
genetic counseling. The sensitivity of a survivor’s mutation status supports the 
prevailing notion that only the survivor should directly contact close relatives. 
The few rigorous evaluations of these approaches consistently show limited 
reach both to survivors and their relatives particularly for rural residents, 
relatives with low income, and racial minorities.5-7 Current specialty-clinic-
centric approaches, despite efforts to expand reach, are not achieving the 
objective to ensure that all groups benefit from increasing knowledge about 
hereditary cancer.
An essential function of public health is to ensure the broad reach of prevention 
programs (e.g., reaching tobacco users to offer cessation programs). However, 
health professionals have yet to apply much of the three-decades of evidence 
gained by these programs to promote health among people affected by 
hereditary cancers. Research shows that multi-component, low cost health 
communication interventions including foot-in-the-door techniques,8 
tailored/targeted communications,9 website support,10,11 and short 
messages12 expand reach of prevention messages. Moreover, guidance from 

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theory is critically important to effective cancer communications as fatalistic 
beliefs about prevention and survival are common.13-15 Health professionals 
must anticipate the potential for motivated processing of ovarian cancer risk 
information—denial, counter-arguing or avoidance— that can undermine 
engagement among those who are reached by traceback programs and the 
uptake of genetic services. Theory-based interventions offer strategies to 
counter these responses and suggest that interventionists must develop specific 
messages in collaboration with affected communities.16-18 
The shift from clinic-based promotion of cascade testing to population-level 
traceback programs introduces a number of ethical questions. The current 
prevailing notion that the patient must make the initial contact with close 
relatives warrants reconsideration. Indeed, no systematic efforts have assessed 
close relatives’ preferences regarding direct contact, especially in the 
circumstances where the patient’s mutation status is unknown. Citizen science 
methods offer a low cost and feasible platform for gaining community wisdom 
and creativity related to the ethical challenges of population outreach. 
With the availability of life-saving prevention options, we need novel approaches 
to identify, engage and inform ovarian cancer survivors and their close relatives 
about their risk. State cancer registries are a viable platform to use low cost 
outreach approaches to contact survivors, offer genetic counseling and testing as 
well as options for contacting relatives.1,19,20 
4.0
Study Endpoints*
4.1
Primary RCT outcomes: 1) Survivor reach: the proportion of the eligible 
survivors identified and contacted by GCR who log in to the website, 2) Close 
relative reach: the proportion of close relatives enumerated by survivors who log 
in to the website, and 3) Uptake of cancer genetic services: the proportion of 
untested survivors who complete telegenetic counseling and the proportion of 
relatives enumerated who complete B-RSTTM screening and subsequently 
access genetic counseling. We will evaluate secondary outcomes: In the MBI 
arm, we will track survivor’ and relatives’ patterns of website usage including: 
duration of time on the website, number of return visits, pages viewed, and the 
proportion of survivors who select different relative contact options.
5.0
Study Intervention / Design 
We propose a multi-component, low cost, message-based communication 
outreach intervention to engage ovarian cancer survivors and their at-risk 
relatives in considering cancer genetic services. The intervention includes 
foot-in-the-door techniques, tailored/targeted print, website support, and 
short messages to expand reach of prevention messages. An outreach 
website with content for both survivors and close relatives will be the hub 
channel in the communication intervention wheel. In turn, we will 
encourage access to the website using other communication channels as 

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spokes in the wheel including: 1) Initial print-based contact to survivors 
sent by the cancer registry, 2) additional briefer reminder postcards and 
short text message cues (SMS), 3) additional short text message cues sent 
directly to close relatives (with contact information and permission 
provided by the survivor).  
6.0
Procedures Involved*
6.1
Describe study procedures.
Study Overview: We propose two phases of study activities. Phase 1 (Aim 1) comprises 12 
months of collaboration with survivor/family working groups to develop: targeted letters, choice 
options for relative outreach, and content for an interactive website, and short cueing messages 
that engage ovarian cancer survivors and their at-risk relatives in considering genetic risk 
assessment. All of these study materials will be submitted as an IRB amendment prior to 
fielding. Phase 2 (Aims 2-3 – Years 2-4), is an RCT that compares the message-based intervention 
(MBI) with current standard outreach. We will evaluate the following outcomes: survivor reach, 
at-risk relative reach, and uptake of appropriate cancer genetic services and conduct a process 
evaluation based on the RE-AIM framework that includes survivors and relatives (Aim 3). 
A. Aim 1: Develop a scalable message-based outreach intervention.
A.1. Overarching Approach: We base our community partnerships on the combined principles 
and methods of community-based participatory research and citizen science.21 We propose to 
bring the issue of increasing reach to the community of ovarian cancer survivors and families and 
engage their collaboration to develop appealing messages to expand the reach of genetic services 
to survivors and close relatives. Community members with relevant experience will work with us 
as citizen scientists using their experiences and skills to help develop messages.21 We will hone 
ovarian cancer survivor/family partners’ skills as citizen scientists by familiarizing them with 
theories of information processing, relational autonomy and distributive justice (see below). The 
overarching objective is to co-create content that has the greatest potential to engage 
survivors/relatives to thoughtfully consider the tradeoffs of genetic service uptake. Dr. Escoffery, 
Ms. Paris and Peachtree Solutions have considerable experience working with community 
advisory boards (CABs) and end users. Dr. McBride has conducted qualitative research to develop 
genetic risk messages in a variety of settings in the U.S. and abroad.22-24
A.2. Study Population and Procedures: Development of the MBI will involve three iterations and 
the following stakeholders: 1) community members who have a personal and/or family history 
of ovarian cancer; 2) communication and bioethics experts (Drs. McBride, Shepperd, Guan, Pentz, 
Emory’s Visual Medical Education team); and 3) cancer genetics content experts (Drs. Guan, 
Bellcross, Meisel). Georgia CORE’s CABs will help us identify 35-40 community members via 
snowball sampling to participate in working groups (see letters of support). We will share 
eligibility criteria with Georgia CORE (e.g. ovarian cancer survivor/family, access to the internet 
and being available for in-person or online group discussions). Ms. Paris (Co-I) will oversee these 
activities with the assistance of an ethics fellow and a research assistant. In assembling the 
working groups, study staff will conduct additional eligibility screening (e.g., prior experience 
with cancer genetic services, family size) to increase the diversity of community members for 

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working group activities. We will subdivide the community members based on their expertise 
and preference into 3 working groups consistent with a citizen science philosophy. Each group 
will contain 5-10 survivors and/or close relatives who will work on specific tasks and intervention-
related products. Participants will receive $500 for attending 2-3 90-minute in-person meetings 
and some additional outside “homework”. For each in-person working group session, we will 
prepare an interactive didactic module with lay explanations of theory-based concepts related to 
the working group’s task. The remainder of the session will focus on a specific task (e.g., plans to 
interview other family members to solicit example experiences, preference for being contacted). 
We will give working groups ongoing updates as the study progresses and share the study results 
in a final discussion group half-day meeting described in Aim 3.
A.3. Working Group Procedures: Dr. Guan who has experience working with community groups 
and evaluating websites that link those with inherited disease to genetic services will oversee 
working group activities.25 In iteration 1, one community working group will recommend 
approaches for framing the “large ask” and choice sets for relative contact options. A second and 
third working group will assist in collecting survivor-family stories using photonovela or other 
strategies. In iteration 2, content experts in communication, genetics and ethics will assemble 
working group content and develop initial formats for the website and print materials. 
Communication and bioethics experts will review materials for alignment with communication 
frameworks and ethical principles. Next, Peachtree Solutions (see letter of support), our web-
development partner, will work with Emory’s Visual Medical Education team to draft the website 
and print materials. In iteration 3, a third community working group will review initial and revised 
iterations of intervention content using systematic cognitive interviewing methods.26 Peachtree 
Solutions has extensive experience with the latest usability standards and will direct the usability 
testing. The investigative team and consultants will make revisions based on each round of panel 
input. We will use the Suitability Assessment of Materials (SAM) and Comprehensibility (CAM) 
scale to evaluate the readability and comprehensibility of the website with the aim to develop a 
website that users’ rate as “superior”, indicating it is easy to use and understand, low in cognitive 
demand, attention-getting, and motivating.27  
Prior to fielding the trial, we will submit the developed study materials as part of IRB 
amendment.
B. Aim 2: Conduct a two-arm randomized intervention trial (N~2,918).  
B.1. Study Design: We will compare the message-based intervention (MBI) developed in Aim 1 
to standard outreach in a two-arm RCT in Years 2 and 3. The MBI comprises a combination of 
novel intervention components that depart sufficiently from prior research to warrant a 
comparison arm (with access to the MBI website when the trial period is completed).28 Figure 2 
displays the flow of the intervention. 
B.2. Study Population: Study activities will take place in Georgia (GA), where about 615 women 
are diagnosed with ovarian cancer and about 395 die from the disease each year.29 We propose 
a population-wide recruitment approach and will use Georgia Cancer Registry (GCR) to 
retrospectively identify, screen, and enroll all living ovarian cancer patients in GA, diagnosed 
between January 2005 and December 2017. GCR contains information on demographic 
characteristics, condition at time of diagnosis (e.g., stage, histologic types, and other clinical and 

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demographic variables), and treatment history of all cancer patients in GA.29 Since 2001, the 
database excludes borderline (low malignant potential) neoplasms. We will consider women in 
GCR for study participation if they meet four criteria: 1) diagnosed with ovarian, fallopian tube, 
or peritoneal cancers; 2) lived in GA at the time of diagnosis; 3) are not deceased per the registry’s 
records; and 4) have a mailing address. Our review of registry files as of May 2019 revealed: of 
the 8,760 women with a diagnosis of ovarian, fallopian tube, or peritoneal cancer, excluding 
those who were deceased or lost to follow as of 2017, we will have addresses for approximately 
2,918 survivors during the 16-month recruitment period. GA is the 8th largest state with almost 
10.5 million residents; 1.8 million (~17%)30 residents live in rural areas.31 The state enjoys 
substantial racial-ethnic diversity: 32% of the state is Black or African American alone (4th largest 
African American population in the U.S.), 9.6% is Hispanic or Latino and 4.2% is Asian alone, 15% 
of the population lives in poverty, and 15% lack health insurance.30
The efficient recruitment of survivors presents logistical challenges particularly given the high 
mortality rate of ovarian cancer. We made the deliberate decision to reach out to ovarian cancer 
survivors diagnosed back to 2005 based on: 1) our message-based communication traceback 
approach that targets ovarian cancer survivors with short- and long-term survivorship to include 
diagnoses that predated changes in testing guidelines32; 2) survivors diagnosed more than a 
decade ago are underrepresented in the majority of case identification trials with self-selected 
samples in specialty clinical settings; 3) we expect rates of recruitment and enrollment to decline 
as we trace back; however, we will potentially maximize the total reach and learn about the 
intervention efficacy across a range of survivor periods; and 4) the cost advantage of using the 
state-wide cancer registry to identify all of the locatable survivors in GA counterbalances 

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recruitment drawbacks. Dr. Escoffery has used similar location and outreach strategies in 
collaboration with GCR to promote mammography and achieved 63% participation rates.33
Others also have used cancer registries to recruit breast and ovarian cancer survivors into clinical 
trials for preventive cancer activities; they contacted survivors zero to nine years post-diagnosis, 
with most reporting response rates between 30-40%.34-42 
B.3. Randomization: We will randomly assign cancer survivors (N=2,918) in a 1:1 ratio to either 
the MBI arm (n=1,459) or the waitlist standard outreach arm (n=1,459). Given our access to the 
entire population of ovarian cancer survivors in GA and characteristics of their cancer and 
treatment, we will use a covariate adaptive randomization procedure.43,44 In this procedure, we 
will randomly assign the first participants to a group, then will assign subsequent participants to 
a particular group by taking the covariates and previous assignment into account to adapt the 
probability of group assignment. This approach ensures our randomization is superior to simple 
randomization that only works perfectly for very large samples.45 It will result in a covariance 
balanced allocation and thus avoid potential influence of covariates on the intervention results. 
We will use the SAS macro developed by Colavincenzo to execute the randomization.46 We will 
choose covariates we expect are related to reach from the cancer registry data. Examples are 
year of diagnosis and age at diagnosis. Registry staff will randomize identified survivors to arm 
using sequentially numbered and sealed envelopes.
B.4. GCR Recruitment Procedures: The proposed recruitment procedures comply with GCR’s 
current standards. We adapted them from strategies that were effective in other studies using 
cancer registry for recruitment34,39,42,47,48 that will allow for sustaining and disseminating the 
intervention beyond the study. We will classify survivors who log in to the study website as 
“reached.” Recruitment will rely on multiple communications aimed to encourage survivors to 
log in to the study website with the number of contacts largely identical for both arms (Figure 4).
B.4.1. First contact letter (MBI arm only): We will mail survivors in the MBI arm a one-page 
infographic (See “U01 MBI infographic draft”) that includes a postage-paid return envelope to 
return their responses to three questions (See “U01 MBI three questions draft”). Responses will 
help us better understand information needs of families affected by ovarian cancer. Participants 
may answer the questions online by using a QR code, or write their responses on the enclosed 
document and return it to GCR. Responses will be anonymous and will not be linked to any 
personal identifiable information. We will not report participants’ responses for research 
purposes and their responses will be reported on an aggregate level (e.g., number of envelopes 
returned). 
B.4.2. First mail-out: This mailing will be sent approximately 7-10 days after mailing the first 
contact letter, we will mail to survivors in both arms $5 cash as a token of appreciation for their 
attention, and a recruitment packet based on their arm assignment: targeted print material in 
the MBI arm versus standard study invitation letter in the standard outreach arm. GCR staff will 
mail recruitment materials in batches of about 172 every month. We will use Accurint, a 
LexisNexis database with coverage across the US, to obtain the most current address for registry 
survivors in an effort to maximize reach of the mailed material on the initial attempt. The 
materials will instruct participants to contact the toll-free registry telephone number with 
questions or concerns. Throughout recruitment, we will perform monthly checks to avoid 

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initiating contact with a recently deceased woman. To reduce unnecessary contact attempts by 
GCR, the intervention coordinator will provide GCR with the IDs of survivors who have logged in 
to the study website on a biweekly basis. 
B.4.3. Telephone contacts: Studies show that interpersonal communications, such as a personal 
phone call, can increase clinical trial accrual when combined with informational handouts.48-53 
Two weeks after mailing each packet, GCR will contact survivors by phone who do not log in to 
the study website. We will call survivors every 2-3 days for up to 9 attempts, after which we will 
categorize them as inaccessible. The phone call aims to: 1) check on receipt of the recruitment 
packet; 2) remind survivors to log in to the study website; and 3) answer questions regarding the 
study.  This schedule is the standard for GCR outreach.
B.4.4. Second mail-outs: Survivors who do not log in to the study website within 2 weeks of the 
last phone call attempt will receive a second mail-out containing the full recruitment packet.
 
B.5. Message Based Intervention (MBI) Arm: In collaboration with the working groups we will 
develop messages to increase perceived relevance (e.g., photonovela stories), and prompt 
website access (e.g., SMS reminders of passwords). Messages will be included in: a website hub, 
initial print-based contact to survivors sent by the cancer registry, reminder postcards and short 
text message cues (SMS) for survivors and close relatives (when contact information and 
permission is provided by the survivor). We will work with Emory’s Visual Medical Education team 

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of certified medical illustrators to design illustrations for these products to increase the 
accessibility of complex medical concepts. 
B.5.1. Survivor components: We will send the initial full recruitment packet to identified survivors 
randomized to the MBI arm. The packet will contain theory-based targeted messages developed 
in Aim 1, and a cover letter that explains how we identified the woman, and provide her with a 
unique login to access the website that we can track and link the survivor to the cancer registry. 
Figure 3 displays the intervention flow. 
B.5.1.a. Website: The study website developed in Aim 1 
will be a centralized information delivery portal that 
contains: graphical depictions of genetic risk, short 
videos on hereditary cancer risk, photonovelas, 
structured interactive Q&A choices highlighting pros and 
cons of seeking genetic services from the perspectives of 
survivors, and resources for patient navigation programs 
near them. On entering the website, survivors will see an 
explanation of the study and the opportunity to continue 
or to decline. The online consent form ends with the "I 
agree" checkbox so the participant can decide whether 
they still want to participate after reading the listed 
conditions. Dr. McBride successfully used a similar 
approach with 6,400 enrollees in a managed care 
organization.54 Fully 32% of those who received mailed 
invitations with log-in information visited the website.55 
Results showed high levels of information recall and 
accurate interpretations of the limits of the genetic 
susceptibility testing for common diseases suggesting 
this platform enabled informed consent.56 The website 
will ask survivors who log-in to review informed consent 
information, click the “I agree” button if they want to 
proceed, and on a separate webpage to complete the 
requested “small ask” task to enumerate their 1st and 
2nd-degree relatives (henceforth “close relatives”) by 
first name only and to specify the relationship. Once 
completed, the survivor will view options for how close 
relatives might be contacted (we will present 3-4 options 
that represent graduated involvement of study staff). We will pair each option with personal 
stories to illustrate pros and cons of the choices. The website will then prompt survivors to 
complete the “large ask” task, which entails selecting an option (e.g., close relatives contacted 
solely by survivor, share contact of some relatives with study team, study team contact all  
enumerated relatives, refuse contact, etc.). Survivors who select options that involve the study 
team reaching out on the survivor’s behalf will be prompted to provide contact information (e.g., 
mailing address, email, phone number) for relatives. Relatives specified for study contact will be 
sent (via email, mail or text) personal login information linked to the survivor; provide survivors 

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who opt to contact relatives will be provided with unique log-in information for each of the 
relatives they list. Relatives that survivors refuse contact will be noted but not contacted. 
B.5.1.b. Short messages: Survivors who provide mobile phone numbers will receive two SMS 
thanking them for accessing the website, and encouraging them to revisit the website to review 
information and contact relatives. We will time these cues to occur at 3-week intervals over a 6-
week time period (two SMS). Additionally, reviews of SMS studies suggest including a substantial 
pre-testing phase that allows target audiences to provide input on message content as we 
propose to do in Aim 1.
B.5.1.c. Genetic service options: We will offer free pre-test telegenetic counseling to all survivors 
who log in to the website, regardless of whether they complete the tasks. Two recent trials 
showed that similar approaches are non-inferior to face-to-face counseling.57,58 Survivors can opt 
for phone and/or video counseling via Emory HIPPA approved Zoom links. They can schedule a 
session (~60 min) on the study website by providing their contact information and preferred 
appointment date/time. We will ask survivors to review an online genetic counseling consent 
form and complete a brief intake survey (e.g., prior genetic testing result). Survivors may invite a 
support person or other family members to participate in the session. Scheduling a telegenetic 
counseling session indicate that participants agree to receive services provided by means of 
telemedicine by a genetic counselor intern at Emory University. Genetic counseling interns 
(supervised by Drs. Guan and Bellcross) will proactively contact consented survivors for the 
counseling sessions. Interns will be blinded to participant’s/relatives study-arm assignment. All 
interns will have comprehensive training in cancer genetics and use of telemedicine. The intern 
will be trained in best practices: review personal and family medical history, discuss appropriate 
genetic tests (e.g., minimum BRCA and Lynch syndrome, other genes based on survivors’ family 
history), and discuss the risks/benefits/limitations of recommended tests. Interns also will 
receive training in how to refer survivors to informational and support resources, including any 
local patient navigator programs to assist the participant with additional medical care needs. 
Participants will receive a copy of their pedigree, a medical referral letter summarizing key 
aspects of the counseling session and recommendations for genetic testing. We will recommend 
that participants share these letters with their primary care provider (PCP) as follow-up. If 
participant’s prefer, the intern can work with the PCP to arrange genetic testing. We will also 
offer post-test telegenetic counseling at no cost to all participants. Medicare's covers BRCA1/2 
genetic testing for people with personal history of ovarian cancer. In addition, the Genetic Testing 
Fund established by Georgia CORE (Ms. Paris, President and Co-I) provides access to genetic 
testing for hereditary breast and ovarian cancer for uninsured Georgians.59 Since 2014, the Fund 
has supported testing for over 70 underinsured Georgians who would not have otherwise been 
able to afford it.  
B.5.2. Close relative procedures: Relatives eligible to participate must be: 25 years or older (age 
recommended to initiate preventive behaviors)60, able to access the internet, a 1st or 2nd degree 
relative of the survivor, able to read English, and non-incarcerated or institutionalized. Relatives 
will receive a unique website login linked to the survivor that enables access to the website 
content and describes pros/cons of family-history-based genetic risk screening for HBOC. 
Additionally, relatives for whom we have cell phone numbers will receive 3 cueing SMS reminders 
over 9 weeks (developed during Aim 1). The SMS will thank them for visiting the website and 

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suggest they return as needed and complete the genetic risk assessment for ovarian cancer 
family history. We will use the B-RSTTM (developed and validated by Dr. Bellcross in 2009),61,62 
which is endorsed by the USPSTF as one of several validated screening tools that is clinically useful 
for estimating the probability of BRCA1/2 mutation and identifying women for referral to genetic 
counseling. This screener assesses personal and family history (1st and 2nd relatives) of breast 
cancer, bilateral breast cancer, ovarian cancer and male breast cancer, and Ashkenazi Jewish 
heritage. The intervention website will include a separate portal dedicated to the B-RSTTM 3.1 
screen. Although all 1st or 2nd degree relatives of ovarian cancer survivors will screen positive on 
B-RSTTM, completing the screener will raise participant awareness of the factors that contribute 
to hereditary risk of ovarian cancer and will reinforce the salience of seeking genetic counseling. 
We will recommend genetic counseling for all close relatives because of their heightened risk for 
carrying a BRCA1/2 mutation. We will direct interested relatives to the same telegenetic 
counseling services provided to survivors. Ideally, we would recommend testing the survivors 
first, and only offer genetic testing to close relatives with a confirmed pathogenic variant ala 
cascade testing. However, we will offer genetic testing to relatives regardless of survivor’s testing 
status.
B.6. Standard Outreach Arm 
B.6.1. Survivor components: GCR will mail survivors a standard letter and log-in information. 
Survivors will have access to a condensed version of the website that includes information on: 
genetic risk and genetic counseling, patient navigators in their locale, and the importance of 
conveying information to close relatives. Survivors will be provided with 2 extra letters and login 
information for 2 close relatives. Survivors can request additional relative letters/logins for any 
relatives that they would like to involve on the website or the GCR.
B.6.2. Close relative components: The standard family letter shared by the survivor will provide 
login codes for the relative to visit the condensed website with information about genetic risk 
and the value of completing the online B-RSTTM screener. 
All survivors and relatives in the standard arm will have access to the telegenetic counseling 
services described above. After completion of intervention trial, all survivors in the standard 
outreach arm regardless of their study participation will have access to the MBI sections of the 
website. 
6.2
Procedures being performed to monitor participants for safety or 
minimize risks.
We expect the research-related risk to be minimal: the probability & magnitude of 
harm/discomfort anticipated in the research is no greater than those ordinarily encountered in 
daily life or during the performance of routine physical or psychological examinations/tests.
There are no anticipated physical risks of participating in this study. However, 
participants may experience psychological or emotional distress from participating in 
the study, particularly activities related to the way their family interacts or 
communicates about ovarian cancer and genetic risks. Survivors may worry about their 
family members’ emotional distress. Participants whose motivations for study 

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enrollment include histories of ovarian cancer in either themselves or their family 
members may find it upsetting to re-visit their personal experiences. 
There is a small potential risk of outreach to family members of a recently deceased 
woman. In GCR’s past experiences, this event does indeed happen on occasion but the 
typical response is a family member contacts GCR to inform about the passing of their 
family member. No adverse event has been reported thus far (e.g., distress, confusion). 
The proposed research activities present the same outreach risk (which is minimal) as 
routine contact by the GCR.
Other potential risks to participation include the possibility of a breach of confidentiality 
or data privacy in which the study participant’s involvement in genetic counseling, 
comments or survey information may become known by individuals not directly 
involved in the research. 
In order to attenuate the likelihood and impact of these potential risks:
Throughout recruitment, GCR will perform monthly checks to minimize the risk of 
initiating contact with a recently deceased woman. If such contact occurs, GCR’s 
standard protocol is that the registry is the single point of contact for all patient 
outreach. The GCR’s primary goal is to ensure that trained registry staff respond to such 
calls and work to reduce possible distress and address questions and concerns per their 
standard protocols.
Participants will be informed that their responses will be described in aggregate and 
they can skip any questions they do not wish to answer, or withdraw from the study at 
any time. Additionally, all of those who log in to the study website (restricted or 
expanded) will be provided with a 24-hour call in line (hosted by the GCR Registry) to 
request contact from the study team regarding any concerns. Jointly, our research team 
includes 2 board-certified genetic counselors (Guan, Bellcross), an oncologist (Meisel) 
and a bioethicist (Pentz) with expertise in areas that may raise concerns for participants.  
We can arrange call backs to participants who register concerns related to their 
participation in the study.
Participants who receive tele-genetic counseling will have the opportunity to have their 
questions/concerns related to genetic screening/testing addressed by the genetic 
counselors as is standard practice. All of the genetic counselor interns will have to 
complete at least one cancer rotation at the time of the study and they will receive 
clinical oversight by senior clinicians including Drs. Bellcross, Guan, and Meisel. Each of 
these genetic counseling professionals have extensive experience in cancer genetics. 
During the online discussions (Aim 3), they will also be available to answer questions 
related to cancer care and genetic counseling via online written responses.
More detail about data security and participant confidentiality are described below in 
the Data Management and Monitoring and Confidentiality sections of this protocol.
6.3
Describe the source records that will be used to collect data about 
participants. (Attach all surveys, scripts, and data collection forms in 

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Smartform on “Study-Related Documents” page under “Other 
Attachments.” If unable to attach data collection instruments due to 
copyright requirements, include description of the instrument in the 
protocol document)
Aim 1: User testing procedures will include structured interviews to assess website content and 
messaging feedback, and the ratings of the website using the Suitability Assessment of 
Materials (SAM) and Comprehensibility (CAM) scale, facilitated by Peachtree Solutions (the 
developer of the website).
Aim 2: Primary data sources include: 1) GCR will record all survivor contacts (i.e., mailings, calls, 
messages left, call-backs), 2) website use reported by Peachtree Solutions on a monthly basis 
(i.e., website login and user-patterns data), 3) genetic counseling interns’ electronic case 
logbook of appointment scheduling and completion, 4) post-intervention online survey.
Aim 3: Data sources are online survey data and participants’ comments on the online discussion 
forums collected from the study website.  
The project is currently in the process of being considered for funding by NCI. NIH requires 
provisional IRB approval for any project to receive funding. At this time there are no documents 
that are ready for IRB review. We state this throughout the protocol, that all documents will be 
submitted prior to interacting with study participants. We are asking that we obtain approval in 
concept for the project, provisional on review of specific materials if the grant is funded. We 
used the same approach for our Deliberative Democracy R21 (IRB00114524) that was funded in 
December, 2019.
6.4
What data, specifically, will be collected during the study and how that 
data will be obtained.
Primary RCT outcomes: 1) Survivor reach: the proportion of the eligible survivors identified and 
contacted by GCR who log in to the website, 2) Close relative reach: the proportion of close 
relatives enumerated by survivors who log in to the website, and 3) Uptake of cancer genetic 
services: the proportion of untested survivors who complete telegenetic counseling and the 
proportion of relatives enumerated who complete B-RSTTM screening and subsequently access 
genetic counseling. We will evaluate secondary outcomes: In the MBI arm, we will track 
survivor’ and relatives’ patterns of website usage including: duration of time on the website, 
number of return visits, pages viewed, and the proportion of survivors who select different 
relative contact options. We can also link survivor and relative patterns of use to evaluate 
“family” patterns of use. We will assess the proportion of survivors and relatives who self-
report in the post-intervention online survey (described below) having completed genetic 
testing, but we will not have sufficient power to consider uptake of genetic testing as a primary 
outcome.
Primary data sources include: 1) GCR will record all survivor contacts (i.e., mailings, calls, 
messages left, call-backs), 2) website use reported by Peachtree Solutions on a monthly basis 
(i.e., website login and user-patterns data), and 3) genetic counseling interns’ electronic case 

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logbook of appointment scheduling and completion. We will limit website data collection to 
information regarding survivor’s prior genetic counseling/testing, enumeration of relatives, and 
contact information for relatives with survivors’ approval to contact. We will limit data 
collected from relatives on the website to telephone number, home address, email addresses, 
and to prior experiences with genetic counseling/testing. We decided against a formal survey 
prior to or during the intervention to minimize participant burden and to enable a cleaner 
evaluation of the feasibility of using the proposed intervention to maximize survivor/relative 
reach. 
Post-intervention online survey: We 
will recruit survivors and relatives 
who logged on to the website, 
regardless of their level of 
participation. We will post a study 
invitation letter and a one-time 20-
minute survey on the study website 
and send the letter to survivors and 
relatives with contact information 
(e.g., mailing address, email, or 
mobile phone number) about 4 
weeks after the intervention phase. 
Based on our sample size scenarios in Table 3 we estimate recruiting 120 survivors (15% 
response rate) and 66 relatives (15% response rate) to complete the online survey. We will 
compensate participants with $35 to complete the online survey. In other research, we used an 
online survey to evaluate recall of B-RSTTM results following a mammogram screening visit; 35% 
agreed to complete an online survey with a $25 incentive.63 We will include measures of (Table 
2): Ability to process health information (“How confident are you filling out medical forms by 
yourself?”) This item correlates strongly with longer health literacy assessments142; We will 
assess central processing in several domains: a 7-item breast/ovarian cancer genetic knowledge 
scale143, recall of the B-RSTTM result (correct/incorrect), accuracy of perceived likelihood of 
carrying a BRCA1/2 mutation, and accuracy of perceived absolute risk of ovarian cancer (“how 
likely is that you will develop ovarian cancer in your lifetime?”).63-65 We  will assess defensive 
processing with a 9-item information acceptance scale in which relatives respond to statements 
such as, “The information I received about my risk for hereditary breast and ovarian cancer 
seems accurate” (scores range from 0-45, a higher score indicates a high acceptance)63. Cancer 
fear is based on 3-items (e.g., “of all the diseases, I am most afraid of cancer.”)66 We will assess 
comparative risk perception with a single item “compared to the average woman your age, 
would you say that you are less likely/as likely/more likely to develop ovarian cancer.” 
Prevention efficacy: We will assess ovarian cancer fatalism with two items (e.g., “If a woman is 
meant to get ovarian cancer, she will get it no matter what she does?”).66 Other measures: 
cancer genetic testing (yes/no), extent of family discussions about ovarian cancer, and relevant 
demographics.30 

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Process Data Collection and Measures: To measure reach (coverage and participation rates) and 
dosage (intervention delivered and received), we will electronically track the number of 
mailings/phone calls to each participant, website usage pattern, request for genetic counseling, 
and the completion of genetic counseling and testing. Fidelity: For quality control purposes, Drs. 
Guan and Bellcross will evaluate audio-recordings of ~70 sessions (10% of the estimated total) to 
assess whether the following topics have been discussed: personal/family medical history, 
inheritance, appropriate genetic tests, and the risks/benefits/limitations of recommended tests. 
A sum score of 80 (out of 100) will demonstrate good quality of counseling. 
All survey instruments used in the study will be developed in the 12-month planning stage. 
Prior to fielding the study, these instruments and related scripts will be submitted as an IRB 
amendment.
6.5
If there are plans for long-term follow-up (once all research related 
procedures are complete), what data will be collected during this period. 
• N/A.
6.6
If audio/video-recordings will be generated, describe processes for 
transcribing audio/video recordings.  Will audio-recordings be destroyed 
after transcription?  If so, how long after transcription?  If not how will 
they be kept secure?  If video-recordings will be used beyond the current 
research procedures for educational/presentation purposes.
• The genetic counseling sessions will be held on Zoom and the 
meetings will be recorded. After each session, all recorded files 
will be uploaded to Emory password protected, research network 
drives. The recordings will be deleted from any 
computers/laptops after transcription. Access will be given to 
essential team members only. No personal identifiable 
information will be transcribed or reported.
• For quality control purposes, Drs. Guan and Bellcross will evaluate 
recordings of ~70 sessions (10% of the estimated total) to assess 
whether the following topics have been discussed: 
personal/family medical history, inheritance, appropriate genetic 
tests, and the risks/benefits/limitations of recommended tests. 
6.7
Does the research design require subjects to be deceived?
• No. All study subjects must be alive at the time of recruitment.
6.8
Will the subjects be exposed to any stress?
• No. Other potential psychological or emotional distress is described in 
detail in section 6.2. 
7.0
Data and Specimen Banking*
• N/A.

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8.0
Sharing of Results with Participants*
• N/A. This project does not involve investigational diagnostic tests, 
genetic tests, or incidental findings. We will not share any 
participant information with the participant’s physicians. 
9.0
Study Timelines*
9.1
The duration of an individual subject’s participation in the study:
Aim 1 (community working groups): Eligible participants are: English-speaking, have a 
personal and/or family history of ovarian cancer, 25 years or older, have access to the 
internet and be available to attend in-person or online focus group discussions. 
Participants will attend 2 to 3 90-minute in-person meetings and some additional 
outside “homework”.
Aim 2 (message-based intervention (MBI) and waitlist standard outreach approaches): 
Eligible survivors are: diagnosed with ovarian, fallopian tube, or peritoneal cancers, lived 
in Georgia at the time of diagnosis, not deceased, and have a mailing address per the 
Georgia Cancer Registry (GCR)’s records. Study duration could to up to one year. 
Aim 2 & 3 (post-intervention online survey): Survivors and relatives in both arms who 
login to the study website will be invited to complete an one-time online survey. Study 
duration could to up to 30 min.
Aim 3 (mail survey to survivors who did not login to the study website): GCR will send a brief 
survey with a $10 incentive to survivors in both study arms who have never accessed the 
website after GCR completes recruitment efforts. Study duration could to up to 10 min.
Aim 3 (online discussion forum): We propose to purposefully sample survivors (~25) and 
relatives (~25) randomized to the MBI arm to participate in an online discussion forum. Study 
duration could to up to 1 hour.
Aim 3 (re-engagement of working groups, Year 4): After data analysis is complete (late 
Year 4), we will reengage community working groups from Aim 1 for a half-day 
workshop where we will report findings of the intervention and enlist additional 
feedback. 
9.2
Totally duration of overall study: Four years.
10.0 Subject Population*
Aim 1 (community working groups): English-speaking, have a personal and/or family history of 
ovarian cancer, 25 years or older, have access to the internet and be available to attend in-person 
or online focus group discussions.
Aim 2 (message-based intervention (MBI) and waitlist standard outreach approaches): 
Survivors: diagnosed with ovarian, fallopian tube, or peritoneal cancers, lived in Georgia at the 
time of diagnosis, not deceased, and have a mailing address per the Georgia Cancer Registry 
(GCR)’s records. Relatives of survivors: able to read English, be 25 years or older, have access to 

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the internet, be a first- or second-degree relative of the survivor, and not be incarcerated or 
institutionalized.
Aim 2 & 3 (post-intervention online survey): Survivors and relatives in both arms who login to 
the study website.
Aim 3 (mail survey to survivors who did not login to the study website): Survivors in both study 
arms who have never accessed the website after GCR completes recruitment efforts. 
Aim 3 (online discussion forum): Survivors and relatives randomized to the MBI arm who login 
to the study website. 
11.0 Vulnerable Populations*
• N/A.
12.0 Local Number of Participants
1240
13.0 Recruitment Methods
Aim 1 (community working groups): We will collaborate with local community organizations and 
use snowball sampling approaches to recruit35-40 individuals to serve in study working groups. 
To be eligible, individuals must : speak English, have a personal and/or family history of ovarian 
cancer, be 25 years or older, have access to the internet and be available to attend in-person or 
online focus group discussions. In assembling the working groups, study staff will conduct 
additional eligibility screening (e.g., prior experience with cancer genetic services, family size) to 
increase the diversity of community members for working group activities. Georgia CORE 
Community Advisory Boards (CAB), the Cancer Patient Navigators of Georgia, and the 
Survivorship Advisory Board have extensive experiences working with cancer survivors across 
Georgia and will assist in recruitment for Aim 1 (See letters of support). Ms. Nancy Paris (Co-I) 
will oversee these activities with a research assistant and an ethics fellow. Two community 
consultants nominated by Ms. Paris will work with local organizations to recruit working group 
participants. Additionally, we will approach organizations where members are more likely to have 
undergone genetic counseling/testing and include male members to increase diversity on these 
characteristics. Participants will receive $500 for attending 2 to3 90-minute in-person meetings 

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and some additional outside “homework”. Recruitment of community members will take 
approximately 3 months at the beginning of Year 1.
Aim 2 (message-based intervention (MBI) and waitlist standard outreach approaches): Ovarian 
cancer survivors in the Georgia Cancer Registry (GCR) database who meet the following criteria 
will be considered for study participation: 1) diagnosed with ovarian, fallopian tube, or peritoneal 
cancers; 2) lived in Georgia at the time of diagnosis; 3) currently are alive per the registry’s 
records; and 4) have a mailing address. The proposed recruitment procedures comply with GCR’s 
current standards and are adapted from strategies that were effective in other studies using 
cancer registry for recruitment.1-5 We will classify survivors who log in to the study website as 
recruited. Recruitment will rely on multiple communications aimed to encourage survivors to log 
in to the study website; the number of contacts will be largely identical for both arms: first mail-
out (full packet plus $10 incentive), telephone contact from a trained GCR staff, second mail-out 
(postcard reminder), and third mail-out (full packet). Our review of registry files as of May 2019 
showed that: of the 8,760 women with a diagnosis of ovarian, fallopian tube, or peritoneal cancer 
(excluding those who were deceased or lost to follow as of 2017), we will have addresses for 
about 2,918 survivors over the 16-month recruitment period. In a recent study using GCR to 
recruit breast cancer survivors in Georgia with registry standard mailing and phone contact 
without financial compensation, 63% agreed to participate.6 A conservative assumption of 
reaching (i.e., log in to the study website) 45% in the MBI arm versus 10% in the standard 
outreach arm, we need to recruit 801 cancer survivors into our study. Relatives of survivors 
eligible to participate must be: 25 years or older, have access to the internet, be a first- or second-
degree relative of the survivor, able to read English, and not be incarcerated or institutionalized. 
We estimate that 801 cancer survivors will log in to the website and 75% of them (N=601) will 
enumerate a median of 2 at-risk relatives. We assume the number of at-risk relatives enumerated 
will not differ between intervention arms. Furthermore, we estimate that 40% of relatives 
referred by MBI arm participants will log on compared to 20% in the standard outreach arm. We 
expect that about 438 relatives will participate in the study. Recruitment of survivors and 
relatives for the intervention will occur in Year 2 and 3. 
Aim 2 & 3 (post-intervention online survey): We will recruit survivors and relatives who logged 
on to the website, regardless of their level of participation. We will post a study invitation letter 
and a one-time 20-minute survey on the study website and send the letter to survivors and 
relatives with contact information (e.g., mailing address, email, or mobile phone number) about 
4 weeks after the intervention phase. Based on our sample size scenarios we estimate recruiting 
120 survivors (15% response rate) and 66 relatives (15% response rate) to complete the online 
survey. We will compensate participants with $35 to complete the online survey. In other 
research, we have used an online survey to evaluate recall of B-RSTTM results following a 
mammogram screening visit; 35% agreed to complete an online survey with a $25 incentive.7 
Recruitment of survivors and relatives for the online survey will take approximately 3 months at 
the beginning of Year 4.
Aim 3 (mail survey to survivors who did not login to the study website): GCR will send a brief 
survey to survivors in both study arms who have never accessed the website after GCR completes 
recruitment efforts. Based on our prior recruitment data, about 1,686 survivors will not visit the 
study website by Jan, 2023 and will be eligible for this survey. We will conduct staged selection 

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of 650 non-responders over the 8-month recruitment period (Jan – Aug 2023): (1) reach out to 
all participants with a confirmed phone number (GCR have talked to participants during trial 
recruitment or their voicemail states their name); 2) reach out to all participants with a confirmed 
mailing address (GCR confirmed the mailing address through at least two resources (GCR 
database, ACCUR or voter registration database); and 3) reach out to participants whose ovarian 
cancer diagnosis is within five years. We aim to recruit 375 survivors for this survey. The proposed 
recruitment procedures comply with GCR’s current standards. Recruitment will rely on two 
rounds of communications aimed to encourage non-responders in both study arms to complete 
the survey (Figure 4). 
The first mail-out packet will include a survey cover letter (See “non-responder survey cover 
letter”), $10 cash, a postage-paid return envelope to return completed survey, and a 10-min 
survey (See “Non-responder survey draft”) that asks about participant recall of receiving study 
materials, perceived importance and relevance of learning ovarian cancer risks, privacy concerns 
about health website, and trust in university health research. Participants may answer the 
questions online by using a QR code or write their responses on the enclosed document and 
return it to GCR.
Two weeks after mailing each packet, GCR will contact survivors by phone who do not complete 
the survey online or by mail. We will call survivors every 2-3 days for up to 5 attempts, after which 
we will categorize them as inaccessible. The phone call aims to: 1) check on receipt of the survey 
packet; 2) offer survey completion by phone; 3) remind survivors to complete the survey by mail 
or online; and 4) answer questions regarding the study. This schedule is the standard for GCR 
outreach.
Aim 3 (online discussion forum): We propose to purposefully sample survivors (~25) and 
relatives (~25) randomized to the MBI arm to participate. We will conduct cluster analysis based 
on 2/3rds of the recruited sample to assess patterns of website use and identify sub-groups of 
users. We will use multinomial regression analysis to understand sociodemographic differences 

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in cluster members and use the clusters as strata for the recruitment into the online discussion 
forum. These analyses will allow us to identify “user profiles” and stratify sampling to increase 
representation of various user patterns based on GCR contact effort, website usage (high/low), 
and uptake of genetic counseling/testing (yes/no). We will send invitations and identify a back-
up individual from the waiting list, should the original invitee decline. Participants will receive 
information 
about 
how 
to 
participate 
in 
the 
online 
discussion 
forum 
via 
email/mail/phone/website postings. Recruitment of survivors and relatives for the online 
discussion forum will take approximately 3 months at the beginning of Year 4.
All survey instruments used in the study will be developed in the 12-month planning stage. 
Prior to fielding the study, these instruments and related scripts will be submitted as an IRB 
amendment.
14.0 Withdrawal of Participants*
Participants will be informed that they can choose not to participate in the study. They 
can skip any questions they do not wish to answer, or withdraw from the study at any 
time.
15.0 Risks to Participants*
We expect the research-related risk to be minimal: the probability & magnitude of 
harm/discomfort anticipated in the research is no greater than those ordinarily encountered in 
daily life or during the performance of routine physical or psychological examinations/tests.
There are no anticipated physical risks of participating in this study. However, 
participants may experience psychological or emotional distress from participating in 
the study, particularly activities related to the way their family interacts or 
communicates about ovarian cancer and genetic risks. Survivors may worry about their 
family members’ emotional distress. Participants whose motivations for study 
enrollment include histories of ovarian cancer in either themselves or their family 
members may find it upsetting to re-visit their personal experiences. 
There is a small potential risk of outreach to family members of a recently deceased 
woman. In GCR’s past experiences, this event does indeed happen on occasion but the 
typical response is a family member contacts GCR to inform about the passing of their 
family member. No adverse event has been reported thus far (e.g., distress, confusion). 
The proposed research activities present the same outreach risk (which is minimal) as 
routine contact by the GCR.
Other potential risks to participation include the possibility of a breach of confidentiality 
or data privacy in which the study participant’s involvement in genetic counseling, 
comments or survey information may become known by individuals not directly 
involved in the research. 
In order to attenuate the likelihood and impact of these potential risks:
Throughout recruitment, GCR will perform monthly checks to minimize the risk of 
initiating contact with a recently deceased woman. If such contact occurs, GCR’s 
standard protocol is that the registry is the single point of contact for all patient 

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outreach. The GCR’s primary goal is to ensure that trained registry staff respond to such 
calls and work to reduce possible distress and address questions and concerns per their 
standard protocols.
Participants will be informed that their responses will be described in aggregate and 
they can skip any questions they do not wish to answer, or withdraw from the study at 
any time. Additionally, all of those who log in to the study website (restricted or 
expanded) will be provided with a 24-hour call in line (hosted by the GCR Registry) to 
request contact from the study team regarding any concerns. Jointly, our research team 
includes 2 board-certified genetic counselors (Guan, Bellcross), an oncologist (Meisel) 
and a bioethicist (Pentz) with expertise in areas that may raise concerns for participants.  
We can arrange call backs to participants who register concerns related to their 
participation in the study.
Participants who receive tele-genetic counseling will have the opportunity to have their 
questions/concerns related to genetic screening/testing addressed by the genetic 
counselors as is standard practice. All of the genetic counselor interns will have to 
complete at least one cancer rotation at the time of the study and they will receive 
clinical oversight by senior clinicians including Drs. Bellcross, Guan, and Meisel. Each of 
these genetic counseling professionals have extensive experience in cancer genetics. 
During the online discussions (Aim 3), they will also be available to answer questions 
related to cancer care and genetic counseling via online written responses.
More detail about data security and participant confidentiality are described below in 
the Data Management and Monitoring and Confidentiality sections of this protocol.
16.0 Potential Benefits to Participants*
Participants may or may not benefit directly by taking part in this study. Through reviewing the 
print- and website-based communication materials and undergoing genetic counseling, 
participants may develop a broader knowledge base, competence and confidence to interpret 
and analyze genetic risk information related to hereditary cancers. If participants choose to 
undergo genetic testing in the future and are found to be a mutation carrier of hereditary cancer 
syndromes, the information will be useful for their personal health care management and for 
their family members’ health as well. 
As any risks of participating are anticipated to be minimal, it is believed that the knowledge 
gained from participants’ responses will provide societal benefits that outweigh any risks to the 
participants.
Results of this study could inform the adaptation of similar traceback programs for other 
heritable cancers and in other states to increase the likelihood of fair distribution of precision 
medicine advances.
17.0 Data Analysis, Management* and Confidentiality
Power analysis for RCT: Our study population is equal to (and thus limited by) the population of 
ovarian cancer survivors in Georgia. A recent study using GCR to recruit breast cancer survivors 
in Georgia used registry standard mailing and phone contact without financial compensation, 
which yielded 63% rate of agreeing to participate (Lipscomb, under review). With a conservative 

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assumption of reaching (i.e., login to the study website) 45% in the MBI arm versus 10% in the 
standard outreach arm, we aim to recruit 801 cancer survivors into our study, 656 into the MBI 
arm and 145 into the control arm. We conducted power calculations using SAS PROC POWER to 
assess power given these assumptions. Table 3 shows power for the 4 primary outcomes. We will 
have very good power (β>95%) to detect an intervention effect for each primary outcome. Even 
if we unexpectedly are less successful in recruiting survivors in the MBI arm, we are still powered 
to detect a significant intervention effect for 20% reach in the MBI arm with a total sample size 
of 436. Power analyses for the two primary outcomes for close relatives were conducted 
assuming a design effect (DEFF) of 1.3 expecting moderate clustering in the outcome. Even with 
DEFF=2, we are adequately powered to detect an intervention impact in relatives for reach and 
uptake of B-RSTTM. 
Data analysis for primary RCT outcomes: We will conduct all analyses in SAS 9.4. Because our 
sample is identical with the study population, there will be no missing data for the main outcome. 
We will code people who do not engage in primary study outcomes (e.g., visiting website) as ‘0’, 
and all others as ‘1’. Among participants interacting with the website, we will calculate dose of 
web use as the number of sessions and time spent on the website as indicators of central 
processing. For the main trial outcomes, we will first examine distributions (frequencies and 
means/standard deviations) for all relevant variables. To analyze survivor outcomes, we will use 
logistic regression to analyze arm assignment as a predictor of: 1) reach and 2) uptake of genetic 
counseling yielding an odds ratio and 95% confidence interval for the intervention effect. For 
close relatives outcomes: 1) reach, 2) uptake of B-RSTTM, and 3) uptake of genetic counseling, we 
will conduct a logistic multilevel analysis accounting for clustering of close relatives in cancer 
survivors (i.e. close relatives are level-1 who are nested in level-2). Given the binary nature of the 
outcomes, we will assess dispersion and adjust for over- or under-dispersion in our analyses. 
Subsequently, we will conduct moderator analyses to see for whom the intervention worked 
best. These analyses will entail expanding the described logistic regression/logistic mixed models 
to include direct effects of a proposed moderator (e.g. age at diagnosis) and an interaction effect 
between the moderator and arm assignment. Although the main outcomes will have no missing 
data, our covariates might have missing data. We will assess patterns of missingness and use 
appropriate methods (i.e. full-information maximum likelihood estimation or multiple 
imputations) to account for missing data.
Data analysis for post-intervention online survey: To evaluate factors suggested by information 
processing theories that are associated with the intervention, we will conduct quantitative 

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analyses of survey data to characterize participants’ processing and demographics. We will apply 
linear or logistic regression to compare differences on knowledge, comprehension, between the 
intervention and standard outreach arms. For example, in these analyses we will evaluate 
whether participants in the MBI arm show higher cancer genetic knowledge than relatives in the 
standard outreach arm. Overall, we will adjust these analyses for health literacy and age. 
User Pattern Analysis: To assess patterns of website use and identify sub-groups of users, we will 
use traditional web tool user data (e.g. time of access after invite to use, frequency of use) and 
programmatic user data (e.g. types of viewed content, types of completed tasks). These analyses 
will be conducted approximately 2/3 of the way through recruitment when we have adequate 
numbers for characterizing user patterns. We will identify the sub-groups through descriptive 
analysis and if meaningful using cluster analysis.70 Subsequently, we will use multinomial 
regression analysis to understand sociodemographic differences in cluster members and use the 
clusters as strata for the recruitment into the online discussion forum described above.
Process Outcome Measures: Implementation reach, dosage, and fidelity is based on proportions 
and means/standard deviations for relevant quantitative variables (e.g., website access, number 
of visits/length, counseling session evaluation scores). Outreach approach’s acceptability, 
barriers, facilitators, and perceived alignment with ethical principles will be based on descriptive 
analyses of quantitative survey responses (mail and online – e.g., the proportion of participants 
who vote “yes or no” and rate outreach as protecting autonomy and respecting family 
relationship (relational autonomy). For qualitative responses on the online discussion forum, we 
will conduct qualitative content analysis using MaxQDA. We will identify distinct themes and 
categories related to each discussion topic, such as acceptability, and alternative contact 
strategies and best methods of supporting relational autonomy. Two study team members (led 
by Dr. Pentz) will independently code five responses per discussion topic to ensure agreement of 
coding. Using a final codebook, a bioethics fellow and graduate assistants will conduct coding. 
We will systematically review all responses for the most commonly occurring themes and will 
identify representative quotes. The recorded counseling sessions (~70) will also be qualitatively 
coded to compare 4 measures by study arm: 1) session length in minutes, 2) verbal dominance 
(ratio of counselor to participant statements), 3) patient activation (number of patient medical, 
psychosocial, and lifestyle statements and questions), and 4) nonverbal affect assessed by a 6-
point scale71,72 (low to high) reflecting both positive (interest, warmth, engagement, empathy, 
respectfulness and interaction) and negative affect (dominance and hurried for the genetic 
counselor, anxiety and distress for the patient).
As described in detail in section 19.0, confidentiality safeguards are in place during the 
following activities: recruitment, informed consent process, participation in study website, 
survey and online forum, data transportation, data analysis, and study finding reporting. Only 
the study ID number will be attached to data. In terms of reporting of study results, only basic 
sociodemographic identifiers (e.g., age, income, education) will be reported in aggregate.
18.0 Provisions to Monitor the Data to Ensure the Safety of Participants*

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• N/A. Our project involves no more than minimal risk to 
participants.
19.0 Provisions to Protect the Privacy Interests of Participants and 
Confidentiality of Participants’ identifiable data
To protect participants’ privacy, the community working groups will take place in private settings 
(e.g., conference rooms). Participants in the telegenetic counseling sessions will be asked to 
schedule a time when they can speak privately. The online survey and discussion forum will be 
hosted by the study website and access will be password controlled. We will advise participants 
to use a pseudonym to maintain their anonymity. Participants can share their responses to the 
research team only, or make the responses available for other participants to view. 
Based on existing best practices for security and privacy in health information technology, we 
have employed the technologies and features needed to ensure privacy and security of personal 
information. These features address identity and access management, secure storage, secure 
messaging, encryption, and other security technologies and approaches. The GCR logistical 
survivor contact records on mail-outs and phone calls (i.e., messages left, call-backs) will be 
managed in accordance with HIPAA Privacy Rule, 45 CFR Parts 160 and 164. All other data (i.e., 
website login and user-pattern data, telegenetic counseling logbook, online survey and 
discussion forums) will be collected via HIPAA compliant online platforms developed and 
managed by Peachtree Solutions. All of the data will then be downloaded to Emory password 
protected, research network drives.
Peachtree solutions has three levels of safeguards built into their business approach:  
administrative, technical and physical to insure the security and privacy of sensitive data.  
Administrative safeguards include annual risk assessments of the hosting environment and 
coding practices. Employees are trained annually on the proper handling of sensitive client data 
and secure coding techniques. Policies and procedures are reviewed on an annual basis and 
reviewed by an outside security department on a regular basis as a normal course of business.  
All employees are background checked at the time of hire.  Technical safeguards include quarterly 
external vulnerability scanning, and access controls (e.g., unique user identification; emergency 
access procedures, automatic logoff, authentification, and encryption/decryption). Physical 
safeguards include contingency procedures for facility access in support of data restoration under 
the disaster recovery and emergency operations plan.  All data is stored in an ISO 9001 certified 
facility that requires badge and biometric confirmation to gain access to the data center floor.  
All data is stored in a locked server cabinet that only datacenter employees can access.  Access is 
logged.  Policies and procedures are implemented toward final disposition of PHI that is stored.  
All data is backed up every 3 hours and stored both locally and in a remote data center using hard 
encryption.
Strict confidentiality of the completed data will be maintained. A unique random identification 
number will be generated and assigned to each participants. These identification numbers will 
be used for all data analysis and kept separately from identifying information and accessible only 
by the study team. Identifying information collected for participant recruitment (patient contact 

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lists, phone numbers) will be transferred and stored using secure, encrypted file transfer 
protocols. Encryption will be used for all data in transit between the web browser and the server, 
all identifiable data at rest in the database, and all backups of the data. Access to decrypted 
identifiable data will be limited to a need-to-know basis for study team members. Any data 
collected for research will have identifiable data removed from the data set. All administrative 
accounts will have their own unique login (no shared logins). All data will be secured in password-
protected computer files and reported at the group or aggregate level. Names will not be 
identified in any reports resulting from the research, and no individual information will be 
released to anyone outside of the project. Study personnel will be required to have IRB 
authorization which requires ongoing credentialing regarding procedures to maintain 
confidentiality. Research staff will also sign statements of confidentiality. Only necessary study 
personnel will have access to any of these files. Identifying information (phone numbers) will be 
deleted from all files at the end of the study period.Names will not be identified in any reports 
resulting from the research, and no individual information will be released to anyone outside of 
the project. Study personnel will be trained regarding procedures to maintain confidentiality. 
Research staff will also sign statements of confidentiality. Access to subject personal identifiers 
will be restricted to the PI, recruitment staff, and upon written request, to the Institutional 
Review Board or other appropriate regulatory agencies. Identifying information (phone numbers) 
will be deleted from all files at the end of the study period.
The data and safety monitoring will be conducted annually by an independent data safety 
monitoring committee. The data will be reviewed include: adverse events, enrollment numbers, 
raw data, and outcomes. Safety monitoring results will be reported to the IRB of the Rollins 
School of Public Health of Emory University.
All study team members have current CITI certifications through Emory University. Study team 
members’ preparedness will be enhanced and accomplished by pretrial and ongoing training on 
basic breast cancer and hereditary cancer risk information, study protocol, and ethical conduct. 
In addition, the study team will also receive training in how to refer participants to informational 
and support resources, including patient navigator programs in the survivor’s locale that can 
assist in additional medical care needs.
20.0 Compensation for Research-Related Injury
• N/A. Our project involves no more than minimal risk to 
participants.
21.0 Economic Burden to Participants
• N/A. 
22.0 Consent Process
We request “Waiver of Documentation/Signature only”, given that the research presents no 
more than minimal risk of harm to subjects and involves no procedures for which written 
consent is normally required outside of the research context. More details are included in the 
“Combined_Waiver_Consent_HIPAA_Elements” document. 

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All consent materials used in the study will be developed in the 12-month planning stage. 
Prior to fielding the study, these materials will be submitted as an IRB amendment.
Aim 1 (community working groups): The study team will collaborate with Community Advisory 
Boards (CAB) to identify 35-40 individuals using snowball sampling approaches and provide 
them with information about the study, describe working group procedures, the stipend 
provided for their participation, and obtain permission to provide research staff with their 
contact information.  Study staff will then contact referred individuals and complete a brief 
screener to determine eligibility for the working group, discuss the details of the working 
groups, explain that participation is voluntary, safety of privacy and confidentiality of protected 
health information, and confirm availability. Study research assistants will provide those who 
agree with a printed consent form and discuss any questions. Verbal consent will be obtained 
from participants. Those who participate in the working groups will receive $500 for attending 
2-3 90-minute in-person meetings and some additional outside “homework”. 
Aim 2 (message-based intervention and waitlist standard outreach approaches): The GCR will 
identify eligible cancer survivors and provide them with website access information. Upon entry 
to the study website, we will provide survivors with an explanation of the study and the 
opportunity to continue or to decline. The online consent form ends with the "I agree" 
checkbox so the participant can decide whether they still want to participate after reading the 
listed conditions. Those who agree to participate and include their mobile phone number will 
receive cueing SMS reminders from the study team. Survivors who select choice options that 
involve the study team doing outreach on the survivor’s behalf will receive an additional 
prompt to provide consent and contact information (e.g., mailing address, email, phone 
number) of first and second degree relatives. Relatives, contacted by the survivor or permitted 
to be contacted by the study team will receive a unique website login that is linked to the 
survivor and enables access to a consent form on the study website that describes the study 
procedures, potential benefit and risks, privacy and confidentiality of protected health 
information. Same as survivors, relatives who click the “I agree” button on the informed 
consent webpage would indicate consent. Relatives in the MBI arm who log in to the website 
and are willing to provide a mobile phone number also will receive cueing SMS reminders from 
the study team. All relatives who consent to participate will be directed to complete B-RSTTM 
and the same tele-genetic counseling services. 
All survivors and relatives who log in to the website, regardless of whether they complete the 
tasks, will have access to the same pre-test telegenetic counseling. Survivors can opt for phone 
and/or video counseling via Emory HIPPA approved Zoom links. Participants will be asked to 
review online a genetic counseling consent form. The consent form will include information 
about the procedures of genetic counseling, potential benefits and risks, privacy and 
confidentiality of protected health information, and contact information for the Emory IRB and 
study team. Verbal consent will be obtained by the genetic counselor intern from the 
participant prior to the counseling session. 
Aim 2 & 3 (post-intervention online survey): We will recruit survivors and relatives who log on 
to the study website regardless of their level of participation. We will post a study invitation 
letter and a one-time 20-minute survey on the study website and send the letter to survivors 

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and relatives with contact information (e.g., mailing address, email, or mobile phone number) 
about 4 weeks after the intervention phase. The invitation letter will contain information about 
how to access the one-time online 20-minute survey. After participants click the “I agree” 
checkbox at the end of the online consent form, they will be directed to the online survey link. 
Aim 3 (mail survey to survivors who did not login to the study website): GCR will mail 
survivors a mail-out packet, which will include a survey cover letter (See “non-responder survey 
cover letter”), $10 cash, a postage-paid return envelope to return completed survey, and a 10-
min survey (See “Non-responder survey draft”). Participants will be asked to review the cover 
letter that explains study procedures, voluntary nature of participation, and actions to protect 
their confidentiality. Participants may answer the questions online by using a QR code or write 
their responses on the enclosed document and return it to GCR.
Aim 3 (online discussion forum): We propose to purposefully sample survivors (~25) and 
relatives (~25) randomized to the MBI arm to participate. We will send invitations and identify a 
back-up individual from the waiting list, should the original invitee decline. Participants will 
receive information about how to participate in the online discussion forum via 
email/mail/phone/website postings. Participants will be asked to review the informed consent 
posted on the discussion forum. If they agree to participate, they will click the “I agree” button 
and be directed to the discussion forum. 
Aim 3 (re-engagement of working groups): After data analysis is complete (late Year 4), we will 
reengage community working groups from Aim 1 for a half-day workshop where we will report 
findings of the intervention and enlist additional feedback. Participants will receive $50 for this 
meeting. Verbal consent will be obtained from participants. 
Non-English-Speaking Participants 
Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) 
• Please review our submitted 
Combined_Waiver_Consent_HIPAA_Elements document. 
Participants who are not yet adults (infants, children, teenagers) 
Cognitively Impaired Adults 
Adults Unable to Consent 
23.0 Process to Document Consent in Writing
• N/A. Please review our submitted 
Combined_Waiver_Consent_HIPAA_Elements document. 
24.0 Setting

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Emory University is the ideal setting for the proposed study, as several key resources are 
uniquely poised to support the research outlined in this study. Below we provide an overview 
of the setting and several key resources and how they will contribute to, facilitate, or support 
the study.
Emory Rollins School of Public Health
The Rollins School of Public (RSPH) Health has six academic departments: Behavioral Sciences 
and Health Education, Biostatistics and Bioinformatics, Environmental Health, Epidemiology, 
Health Policy and Management, and Global Health, and hosts over 20 interdisciplinary centers. 
More than 160 full-time, doctoral-level faculty members teach and conduct research in areas 
such as developing behavioral interventions and identifying the social determinants of health. 
RSPH also draws strength from several unique local resources, including the Centers for Disease 
Control and Prevention (CDC, located next door) and the Carter Center. RSPH has a large and 
comprehensive research portfolio (over $90,000,000 in FY2015), with faculty receiving funding 
from a wide range of federal and non-federal sources. The Office of Research is available to 
facilitate faculty research, help identify funding opportunities, enhance the quality of 
applications for extramural research support, stimulate inter-departmental research, and 
provide resources and support for faculty research programs. RSPH faculty members provide a 
rich resource for consultation on analytic, medical, and epidemiologic issues that may arise in 
the course of the proposed research.
In 2010, RSPH more than doubled its physical size with the opening of the 190,000 square foot 
Claudia Nance Rollins building. The nine-story building was designed to achieve Silver 
Leadership in Energy and Environmental Design (LEED) certification. The GCR building, which 
opened in 1994, underwent a major renovation in 2010 to upgrade classrooms, computer 
rooms, and technology. The two buildings combined encompass 330,000 square feet total, 
providing ample office space to house study investigators and staff.
Behavioral Sciences and Health Education Department
The mission of the Department of Behavioral Sciences and Health Education (BSHE) is to better 
the health of all people by advancing knowledge and training tomorrow's leaders in how to 
change behavior and social conditions that influence health. BSHE offers a Master of Public 
Health (MPH) degree and a PhD. The MPH degree is geared toward students with an interest in 
multi-level behavior change interventions, social determinants of health and community 
engagement to enhance dissemination and implementation of effective interventions. BSHE’s 
PhD program is offered through Laney Graduate School, and trains students to identify, 
analyze, and intervene in today's most pressing health issues. 
Major areas of faculty expertise are: (1) the social determinants of health; (2) behavioral risk 
factor trajectories; (3) health education and behavioral interventions; and (4) implementation 
science.  Our research is funded by federal government organizations such as the National 
Institutes of Health (e.g. NCI, NIEHS, NIAAA, NIDA, NIMH), the Centers for Disease Control and 
Prevention, Health Resources and Services Administration, Association of Schools of Public 
Health, and private foundations such as the American Legacy Foundation and Robert Wood 

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Johnson Foundation. We also work with the Georgia Division of Public Health and local health 
departments in Georgia and across the nation.
Our faculty work in diverse areas that involve social-ecological determinants of health and 
diseases. BSHE faculty’s research spans major disease problems (HIV/AIDS, cancer, and heart 
disease) and areas of health promotion (mental health, physical activity, healthy eating), 
specific populations (adolescents, women, minority groups, rural communities), multiple health 
promotion settings (schools, communities, churches, the Internet) and specific behavioral and 
social problems (substance abuse, tobacco control, nutrition, physical activity, injury 
prevention, health communication). Students have many opportunities to work with faculty on 
these research projects.
Laboratory: Not applicable to this project.
Clinical: Not applicable to this project.
Animal: Not applicable to this project.
Computer/Technological
The Information Technology (IT) Department of the Rollins School of Public Health offers a 
state-of-the-art desktop and server infrastructure that supports over 2,500 users. From the 
ground up, it was designed to be modular and expandable in order to give Rollins the greatest 
computing capability, flexibility, and growth potential.
Server Environment
The school’s server environment is based on a combination of UNIX and Windows and can be 
divided into a number of service areas:
Computer Services: The core of our compute services is provided by a high-performance 
computing cluster composed of 18 nodes with an aggregate of 354 processors and 3 TB of RAM. 
Storage is provided through our storage area network (SAN) and the central Isilon storage with 
200 terabytes of RAID-protected HIPAA-compliant storage local on the cluster. The server hosts 
analysis and programming tools including: SAS, SPlus, gFortran, C, C++, Java, R, and MATLAB. 
The application environments are 64 bit and parallel computing enabled when the product 
supports the capability. Services are provided to the desktop using the X Windows and Univa 
Grid Engine interfaces.
Internet/Web Services: Our email services are provided by a central campus resource through 
Office 365, and we have access through a browser or direct interface such as Outlook. We 
provide secure and open access web services. The secure web areas can be restricted to the 
Emory network or an account. There are a number of services that support various CMS, JAVA 
environments, and other web services. We also take advantage of a central IT CMS service 
called Cascade for our main school website. All Rollins web content is served through our local 
web servers, which also support center, program, and personal faculty research websites. We 

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have a number of application environments to support research endeavors such as a Cold 
Fusion development server, RedCap, and Feedback server survey tools.
Database Services: We provide both secure and academic database services utilizing Microsoft 
SQL Server 2008 and MySQL instance. These databases are used to services a number of 
application systems across our administrative and research needs. Database accounts are 
available for any faculty member upon request.
File and Print Services: Based on Windows NT, seven servers work together to provide file and 
print service to the School's desktop network. These state-of-the-art systems provide the latest 
in general use programs, including statistical and mathematical modeling software, database 
management, graphics and office support tools.
Network Environment
Rollins’ network consists of Fast Ethernet hardware running TCP/IP. Ten Gigabit Ethernet 
provides high-speed transmission to the Rollins campus buildings and all other buildings across 
campus. Ethernet provides high-speed (100 Mbps) access to most desktop computers and 
peripheral devices. The network terminates at over 2,500 locations.
The Rollins network is connected to the Emory Campus backbone via a 10 Gigabit Ethernet 
connection, making campus services and wide area network services readily available. We also 
have an extensive wireless network providing “N” class connections and speeds that cover all of 
our buildings and the nearby external areas. This network has guest services as well as secure 
services for our faculty and staff.
Our voice communications are connected into a Unified Communications system that provides 
phones through VOIP and are integrated with our email systems for VMail access. All of the 
secured services inside our firewalls including network storage and other services can be access 
through the Emory VPN.
Desktop Computers
Currently, the analytical computers are at least a I7 CPU configuration with 8GB of RAM 
memory, and have CD/DVD-RW and 20” or higher flat panel monitors standard with 500 gigs 
local disk space and 64 bit Windows. Our Apple Mac environments are generally iMac 
configurations or MacBook laptops with at least 4 gigs of memory. All of our desktop and laptop 
systems are connected to our network storage that provides both highly secure and open 
storage areas.
Our student computing environments are provided through our RSPHDesktop environment. 
This is a Citrix-based virtual desktop environment that provides more than 40 applications to 
our students and is accessible from any place they can get on a network and open a browser. 
Faculty and staff can also request access to the Citrix environment to access these applications 
when working remotely.

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Information Security
The Rollins School of Public Health information technology environment is a HIPAA-covered 
entity and complies with HIPAA and Emory information security and privacy policies and 
practices. In compliance with these policies and practices, Rollins aligns with the National 
Institute of Standards and Technology (NIST) special publications (800 series) for identifying, 
assessing, and managing information security risk within a technology environment.
Drawing on federal and industry best practices, Rollins has implemented a series of multi-
layered security controls to protect the integrity, reliability, and confidentiality of data. A 
sample of the key security controls includes:
•
An annual risk assessment of all Rollins information technology assets with their level of 
risk, potential impact, probability, and controls evaluated based on NIST SP 800-30 Risk 
Management Guide for Information Technology Systems.
•
Rollins and Emory networks are protected by firewalls and intrusion detection devices. 
Rules on these devices are set to deny all traffic by default and "allows" are written as 
exceptions. These devices are updated as appropriate through Emory University's 
change management process and evaluated to ensure they provide the appropriate 
level of protection based on the sensitivity level of the data.
•
Servers are housed within a secured network operating center (NOC). The NOC has 
environmental controls (fire, water, temperature), is accessible only through a two-
factor authorization system (key card and passcode), and is accessible only by 
authorized information technology personnel. In the event of a power outage, the NOC 
devices will draw UPS power from a backup generator.
•
All servers are configured based on Rollins and Emory University best practices. Only 
authorized, trained system administrators have administrative privileges on the servers. 
System administrators monitor security mailing lists and sites and patch/update systems 
based on priority of the patch. All servers are periodically scanned for vulnerabilities and 
any identified vulnerabilities are assessed and managed.
•
All information technology personnel go through background checks before gaining 
access to administrative privileges. At the point of termination with Emory, all 
information technology personnel's administrative privileges are removed.
•
Protected health information (PHI) data and the services that manage them are stored 
on a separate network and server infrastructure with limited access and additional 
security controls.
•
Data is backed up daily. Backups are stored in a tiered structure for disaster recovery 
purposes and include local, off-site, and out-of-state storage. Data stored off-site is 
encrypted to prevent compromise and can only be retrieved by authorized personnel.
•
Data written to any Rollins file servers is checked with server-based anti-virus software. 
Access to data is verified with a local single point of contact within each department 
before any access control is granted. Principal investigators are required to review 
access control lists each year to ensure continued accuracy.
•
All Rollins desktops are configured based on best practices in the industry as well as 
those outlined in NIST SP 800-69 Guidance for Securing Microsoft Windows XP Systems 
for IT Professionals: A NIST Security Configuration Checklist. All Windows machines have 

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anti-virus software installed with updated virus signatures as well as the latest Microsoft 
XP Professional updates. Desktops require authentication from the Emory Active 
Directory to gain access to network services.
•
Security policies are created and reviewed through the Woodruff Health Sciences Center 
HIPAA committee, the Emory University Technology Infrastructure and Policy 
committee, and local policies through the Rollins Information Technology Advisory 
committee.
Conference rooms
The Claudia Nance Rollins Building and Grace Crum Rollins Building have conference rooms that 
allow for the easy hookup of laptops and other computers to be displayed on a large LCD or a 
projected screen. Each conference room has access to the CATV systems as well. Audio 
conferencing is built into the room where no external sound units are required to hold a 
conference call. Each conference room has connectivity abilities for high-end video 
conferencing systems that are wheeled in on a cart. The cart provides a Picture Tel system that 
can share up to four sessions and all of the content and sound connected in the room. The 
audio and video integrated in the room are also available for any PC hooked up to the systems 
so audio can be captured in the room and then used for PC-based video conferencing systems 
such as Skype.
Data protection and backup
We do full back ups of the HPC and servers once a week with incremental back ups on other 
nights. These back ups are kept for 90 days and are encrypted at an off-site location. Network 
shares have snapshots taken nightly, which are kept for 30 days.
Email/Vmail
We use a central IT services resource using Microsoft Office365 for our email. Our email is 
considered sensitive, so we have policies in place that control automated routing of email and 
we use a central spam engine to control propagation of virus and spam attacks. Our phone 
voice mail system is integrated with our email, so voice mails automatically produce email 
audio files upon receipt.
Office
Secretarial and computer support (including fax, e-mail, Internet, color printing, scanning and 
photocopying) are available to all Public Health faculty. 
Other
Six campus libraries are available for use, including the Woodruff Library for Advanced Studies, 
and the Health Sciences Center Library. The university library system has access to thousands of 
journals and periodicals as well as, reference services which include computerized database 
searching. Computer laboratory and audiovisual facilities are also available within the university 
system. The CDC library is also available for use.

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Emory University
Emory University is an international leader in research. Investigators at Emory University 
received $572.4 million from external funding agencies in fiscal year 2015, marking the sixth 
consecutive year of greater than half a billion dollars in research funding. Federal agencies 
awarded more than $375 million, or 66% of the total, led by the National Institutes of Health 
(NIH), with nearly $300 million in awards. NIH funding represented 80% of total federal dollars 
awarded to Emory.
Emory Woodruff Health Sciences Center
Emory’s Robert W. Woodruff Health Sciences Center (WHSC) is an academic health science and 
service center focused on missions of teaching, research, health care, and public service. Its 
components include the Rollins School of Public Health; School of Medicine; School of Nursing; 
Yerkes National Primate Research Center; Winship Cancer Institute; and Emory Healthcare. The 
WHSC has a $3.5 billion budget, 23,400 employees, including 2,940 full-time and 1,300 
affiliated faculty, 5,246 students and trainees, and a $6.8 billion economic impact on metro 
Atlanta. Researchers in WHSC received $537 million in external funding, or approximately 94% 
of the University total.
Emory’s Genetic Counseling Training Program
The Emory University School of Medicine Genetic Counseling Training Program was established 
in
2011, and is the only program of its kind in the state of GA. The program has full accreditation 
through the Accreditation Council for Genetic Counseling. Graduates receive a Master of 
Medical Science
(MMSc) degree in Human Genetics and Genetic Counseling and are qualified to sit for the 
American
Board of Genetic Counseling (ABGC) certification examination.
The Genetic Counseling Training Program’s vision is to transform students through a variety of 
scholarly activities into practitioners, leaders, and advocates for the advanced role of genetic 
counseling within an integrated care team model. The Program’s mission is to provide an 
innovative and rigorous program of training that prepares genetic counselors to serve the 
needs of the healthcare community today while paving the way for incorporating the genomic 
medicine advances of tomorrow.
The program is housed within the Department of Human Genetics on the Emory Campus in 
Atlanta,
GA. The Emory Department of Human Genetics ranks in the top 15 departments in the country, 
with a full-fledged basic research faculty and a comprehensive medical genetics division that 
includes Emory Genetics Clinics and Emory Genetics Laboratory. The department also provides 
training in human and medical genetics for graduate students, laboratory fellows, PAs, medical 
students, and residents. The program offers a unique combination of cutting-edge coursework, 
extensive and varied clinical experiences, and a research-based Focus Internship. The 5-
semester internship allows the student in depth exploration of a specialty area within the 

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settings of public health genomics, clinical genetics practice and research, and laboratory 
genetic services. These internships will be the platform used to engage genetic counseling 
trainees in providing genetic services to ovarian cancer survivors and their relatives who 
complete the B-RSTTM screening tool.
Emory’s Visual Medical Education Team
The VME has a team of four medical illustrators trained in science and digital arts.  Mr. 
Michael Komonos serves as team leader. 
VME endeavors to create innovative designs and models that can revolutionize research, 
education, and patient care. VME is currently working on strategic projects in Surgery, 
Transplant, Neurosciences, Cancer, and Lean process improvement. These projects are 
intended to solve important educational problems that affect a significant number of 
learners and change outcomes. 
VME applies design thinking to solve problems and guide innovation. VME has a number 
of service capabilities including:  animation of 3D and 2D movies; illustrations of static 
images created for various media, design of information and graphics and interface 
design, virtual reality visual illustrations and 3D printing.  These skills are applied in the 
world of medical discovery, care, and teaching. 
Georgia Cancer Registry, Emory University
All of the necessary facilities and resources needed for this project are present at Emory 
University and are listed and described below.  The project requires office space for the PI and 
research staff; supported desktop and server computing; and networking for all personnel.   
This combination of needed facilities and resources was successfully used for our other very 
similar studies.  The specific facilities and resources of the Georgia Cancer Registry are 
described below.
We propose a population-wide recruitment approach and will use Georgia Cancer Registry 
(GCR) to retrospectively identify, screen, and enroll all living ovarian cancer patients in GA, 
diagnosed between January 2005 and December 2017. GCR contains information on 
demographic characteristics, condition at time of diagnosis (e.g., stage, histologic types, and 
other clinical and demographic variables), and treatment history of all cancer patients in 
GA.118 Since 2001, the database excludes borderline (low malignant potential) neoplasms. We 
will consider women in GCR for study participation if they meet four criteria: 1) diagnosed with 
ovarian, fallopian tube, or peritoneal cancers; 2) lived in GA at the time of diagnosis; 3) are not 
deceased per the registry’s records; and 4) have a mailing address. Our review of registry files 
as of May 2019 revealed: of the 8,760 women with a diagnosis of ovarian, fallopian tube, or 
peritoneal cancer, excluding those who were deceased or lost to follow as of 2017, we will have 
addresses for approximately 2,918 survivors during the 16-month recruitment period. GA is the 
8th largest state with almost 10.5 million residents; 1.8 million (~17%)119 residents live in rural 
areas.120 The state enjoys substantial racial-ethnic diversity: 32% of the state is Black or African 
American alone (4th largest African American population in the U.S.), 9.6% is Hispanic or Latino 
and 4.2% is Asian alone, 15% of the population lives in poverty, and 15% lack health 
insurance.119

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Availability of Facilities 
The Georgia Cancer Registry (GCR) is located on the seventh floor of the Grace Crum Rollins 
School of Public Health (RSPH) at Emory University (2 floors above the Behavioral Sciences and 
Health Education Department – offices of Drs. McBride, Guan, Escoffery and Haardoerfer).  The 
cancer registry occupies approximately 1/3 of this floor and employs 28 staff who conduct the 
operations of the registry from this location.  Dr. Ward has his own private office located directly 
outside the registry and GCR research staff share offices next to Dr. Ward.
The CDC’s Cancer Program, including the National Program for Cancer Registries (NPCR), is 
located within a few miles.  Within the Rollins School of Public Health are the Departments of 
Epidemiology, Biostatistics, Environmental and Occupational Health, Health Education and 
Behavioral Science, Health Policy and Administration, and International Health.  The Emory 
Medical School is located within two blocks and the State Health Department is within 15 miles.  
The location of the GCR within Emory University and its proximity to state collaborators provide 
a unique environment with excellent facilities and the opportunity for enhanced interaction with 
other epidemiologic and cancer-related investigators.
Property 
The GCR is equipped with two high capacity, networked laser printers, one Hewlett Packard 
(HP) Laser Jet 600 M602, and one HP Color Laser Jet 4600 dtn.  Other office equipment includes 
a Konica Minolta C224e copy machine.  There is a Brother Intellifax 4100e Business Class Laser 
Fax for the exclusive use of GCR, as well as a Fellowes Powershred C-480 shredder.  Additional 
equipment is available from the Rollins School of Public Health and the University.
Our basic computing needs at the GCR are served by the exclusive use of a Dell PowerEdge 2970 
Quad Core with 4 Gigs of memory.  Storage is provided through our SAN (storage area network) 
over a fiber channel network, with 54 terabytes of RAID-protected HIPAA-compliant storage local 
on the cluster.  It currently has a 20 terabytes of disk space assigned with the ability to quickly 
expand.  Personal desktop computers with are assigned to each in-house staff member, and 
laptop computers are assigned to those that telecommute or perform functions in the field.  
Currently, all computers are at least an I7 CPU configuration with 8GB of RAM memory, and have 
CD/DVD-RW and 20” or higher flat panel monitors standard with 500 gigs local diskspace and 64 
bit Windows.  All computers used by the GCR are encrypted with PGP Whole Disk Encryption and 
require an Aladdin eToken for pre-boot authentication.  They are also managed via LanDesk to 
ensure the latest patches and Symantec anti-virus software.  Trend Micro Anti-Virus Server 
software provides additional protection on the server.  
Support
The GCR receives administrative support, office supplies and all equipment (e.g. computers, 
printers, fax machines, phones, etc) necessary to conduct their operations from the Rollins School 
of Public Health.  All Information Technology support, including day-to-day maintenance of our 
server and IT security infrastructure development and support are provided as well.  Computers 
are refreshed by the RSPH on a 3-year cycle.  Some of the key features of the computing 
environment are presented below.   

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The Information Technology (IT) Department of the Rollins School of Public Health is a state-of-
the-art desktop and server infrastructure that supports over 2500 users. From the ground up, it 
was designed to be modular and expandable so as to give the School the greatest computing 
capability, flexibility and growth potential. 
Server Environment: 
The School server environment is based on a combination of UNIX and Windows 2008 and can 
be divided into a number of service areas: 
Compute Services: The core of our compute services is provided by high performance 
computing cluster composed of 8 compute nodes and 5 job submission nodes with an 
aggregate of 124 core processing cores and 768GB of RAM. Storage is provided through our 
SAN (storage area network) over a fiber channel network, with 54 terabytes of RAID-protected 
HIPAA-compliant storage local on the cluster. The server hosts analysis and programming tools 
including: SAS, SPlus, Fortran 77/90, C, C++, Java, R, MATLAB and IMSL. The application 
environments are 64 bit and parallel computing enabled when the product supports the 
capability. Services are provided to the desktop using the X Windows  and Sun Grid Engine 
interfaces. The files systems are GFS2 based for efficiency and stability. 
Virtual Server Environments: We provide almost all of our servers through a VMWare virtual 
server farm.  Our database, specific applications, web services, and experimental application 
servers are provided through this environment. A faculty member can rent a virtual server 
specifically setup to their specifications for a services fee per month if one of the other general 
server environments does not meet their needs. 
Internet/Web Services: Our mail services are provided by a central campus resource through 
Exchange and we have access through a browser or direct interface such as Outlook. We 
provide  dual web servers split between our secure and our open access areas. The secure web 
areas are controlled at the HIPAA level. There are a number of services that support various 
CMS, JAVA environments, and other web services. We also take advantage of a central IT CMS 
service for our main school web pages being CASCADE. All RSPH web content is served up 
through our local web servers, and they also support center, program, and personal specific 
web areas. We have a number of application environments to support research endeavors such 
as a Cold Fusion development server, RedHat and Feedback server survey tools. 
Database Services: We run a number of database services that range from SQLServer 2005-
2008 and also an instance of mySQL that are provided across both the VM windows 
environments and the LInux systems.  These databases are used to services a number of 
application systems across our administrative and research needs. Database accounts are 
available for any faculty as requested.
File and Print Services: Based on Windows NT, seven servers work together to provide file and 
print service to the School's desktop network. These state-of-the-art systems provide the latest 
in general use programs, including statistical and mathematical modeling software, database 
management, graphics and office support tools. 
Network Environment: The RSPH network consists of Fast Ethernet hardware running TCP/IP. 
Gigabit Ethernet provides high-speed transmission to each of 10 floors and across the RSPH 

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campus buildings and al the other buildings across campus. Ethernet provides high speed (100 
Mbps) access to most desktop computers and peripheral devices. The network terminates at 
over 2500 locations. The RSPH network is connected to the Emory Campus backbone via a 
1Gigabit Ethernet connection, making campus services and wide area network services readily 
available. We also have an extensive wireless network providing “N” class connections and 
speeds that cover all of our buildings and the nearby external areas. This network has guest 
services as well as secure services for our faculty and staff. Our voice communications are 
connected into a Unified Communications system that provides phones through VOIP and are 
integrated with our Email systems for VMail access. All of the secured services inside our 
firewalls including network storage and other services can be access through our VPN firewall 
authenticated specifically to Emory faculty, staff, and students.
Emory’s Winship Cancer Institute
Designated with comprehensive status in 2017, Winship Cancer Institute participates in the 
robust research environment of the Woodruff Health Sciences Center of Emory University, a 
national leader in life sciences.  Emory’s primary focus on translational research fuels the rapid 
development of discoveries in the laboratory into advances in patient care. Winship Cancer 
Institute is supported by a collaborative infrastructure, modern facilities, and programs of wide 
breadth and depth. Winship Cancer Institute of Emory University is Georgia's first and only 
cancer center designated by the National Cancer Institute (NCI). 
Winship, within the broader community of Emory University, participates with four full 
scientific programs and a number of developing scientific programs. Each program is comprised 
of a critical mass of Emory investigators whose cancer research interests in a particular area are 
complementary and synergistic. Numerous opportunities for collaborative studies and large 
team science research endeavors result from a variety of intra and inter-programmatic 
activities. There are four cores: Cancer Cell Biology, Cancer Control and Population Sciences, 
Cancer Genetics and Epigenetics, and Discovery and Developmental Therapeutics. The Cancer 
Control and Population Sciences (CCPS) Program organizes all of the cancer prevention-related 
research activities of the Winship Cancer Institute. These activities span the cancer prevention 
continuum from primary to secondary to tertiary prevention at the individual, select 
population, and societal levels. 
The Winship Cancer Institute Clinical Trials Office (Winship CTO) is a Shared Resource of the 
Cancer Institute. It supports clinical research by providing scientific review, prioritization, and 
monitoring of clinical trials involving cancer patients. The long-term goal of the Winship CTO is 
to advance progress in cancer care through the support of high-quality, high-impact clinical 
research by Cancer Institute members. The focus of the Winship CTO is to help develop and 
support Institutional clinical research studies, particularly phase 1 and institutional studies.
The Clinical and Translational Research Committee (CTRC) maintains the scientific integrity of 
clinical research conducted through the WCI CTO by ensuring that the scientific question being 
addressed is significant, that the study will yield new information relevant to the cancer 

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problem, and that the conduct of the study, including accrual rates, is sufficient to answer the 
scientific question that it is addressing.
The Intervention Development, Dissemination, and Implementation (IDDI) Shared Resource of 
the Winship Cancer Center
The IDDI Core supports the development, testing, and implementation of cancer-focused 
interventions through dedicated research infrastructure. Emory investigators can draw on IDDI 
expertise for support in developing and testing interventions and translating effective 
interventions into real-world practice that makes a difference for patients and communities. 
The IDDI shared resource supports behavioral, educational and systems interventions that 
prevent cancer, detect cancer early, or improve survivorship. Michelle Kegler DrPH, MPH, 
serves as director of the IDDI Core. She is a Professor in the BSHE Department and the Director 
of the Emory Prevention Research Center since 2009. Dr. Kegler is a recognized expert in 
implementation science, participatory research, community partnerships, program evaluation, 
and community-based intervention research in tobacco control and obesity prevention. Cam 
Escoffery, PhD, MPH, co-directs the CORE.  Dr. Escoffery provides expert consultation is an 
evaluator and implementation science researcher. She has employed dissemination and 
implementation science theories and models such as CFIR to evaluate the uptake of evidence-
based cancer prevention strategies by CDC’s Colorectal Cancer Control Program grantees and 
care coordination among high utilizers in the Atlanta Veterans Administration Medical Center. 
Colleen McBride also Co-directs and provides expert consultation research focuses on 
innovative public health interventions to promote risk-reducing behaviors, specifically using 
genetic information to motivate healthy behaviors. 
The IDDI shared resource provides access to a cadre of senior faculty researchers with over 70 
collective years of experience in behavioral science, intervention research, and implementation 
science. They are supported by an experienced team of three MPH-level staff (1.3 FTE) and two 
Graduate Research Assistants (0.6 FTE). The IDDI shared resource offers many services including 
scientific support on study design and intervention approaches, developing surveys and 
qualitative data collection instruments, assisting with community engagement, data collection, 
and qualitative data analysis. IDDI occupies offices in the Rollins School of Public Health and has 
access to a wide range of infrastructure and resources, including a telephone call center with 
seven stations for survey research and NVivo software for qualitative data analysis. 
Peachtree Solutions
See http://www.peachtreesolutions.com for detailed description of the company.
Leadership
Scott Munn
CEO and Founder
System Architect / Software Developer
PCI Security Consultant

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Scott Munn earned his degree at Georgia Tech in Aerospace Engineering. Scott serves as the 
technical lead on all Peachtree Solutions projects. He is hands-on in every phase of project 
design, development and deployment. There are few people with Scott’s mix of technical 
knowledge and business savvy, and clients benefit from his ability to implement even the most 
complex projects. A zealous student of current technology. Scott is an active participant in 
several technology forums.
Lei Lydle
Director of User Experience and Quality Assurance
Web Developer
SEO & Marketing Consultant
Lei graduated from the University of Georgia in 1994 with a Bachelor’s Degree in Risk 
Management.
Lei began as a freelance web design for small businesses in 1996. Lei's skills include Project
Requirements Consulting, Information Architecture, Usability Testing, User Experience Design, 
Graphic
Design, Web Development, Quality Assurance Testing, Management and Online Marketing 
Consulting.
Before joining Peachtree Solutions, Lei worked for several large Atlanta based agencies as Web
Developer where she worked on projects for BellSouth, Delta Air Lines, Chase Manhattan Bank, 
and
WebMD.
Other Staff
Peachtree subcontracts with freelancers from a pool of trusted contractors that are engaged on 
a project-by project basis. These include graphic designers, project managers, programmers, 
and writers.
Facilities
Peachtree Facilities includes a main office (1500 sq ft) located in Peachtree City, GA (a suburb of 
Atlanta).  The main office houses a meeting room with presentation hardware and equipment, 
3 internal offices/workstations with computers and monitors, color and black and white 
printers and is secured by an alarm system.  An internal file server and backup file server also is 
located in this office.  
Our web servers and database servers are housed in the Tier 1 data center at SunGuard, a 
server hosting facility located in midtown Atlanta. SunGuard has over 35,000 square foot 
building equipped with raised flooring and a separate network/data cabling and power cabling 
to minimize interference.  Additionally, regular ISO-controlled preventive maintenance on all 
mission-critical systems are conducted. The SunGuard data centers is where Peachtree 
Solutions host both the development servers and the production servers – (i.e., web servers 
and database servers). 

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Equipment
No equipment is required for this application/project.
Georgia CORE: Center for Oncology Research & Education georgiacore.org
Ms. Nancy Paris is President of the Georgia CORE, a public-private partnership that connects 
cancer care providers, leaders, organizations, and advocates. Led by a Board of Directors of 
experts from cancer centers, hospitals and academic institutions, collaboration orchestrated by 
Georgia CORE improves access to personalized cancer care and support for patients, survivors, 
and caregivers.
In fact, connection and collaboration are at the core of everything we do. Georgia CORE builds 
and nurtures collaboration among people, organizations and institutions dedicated to 
improving cancer care in Georgia. Our statewide network is dedicated to generating creative, 
personalized resources. Because we are the only statewide organization working with such a 
vast array of groups, we are able to leverage public and private funding to provide greater 
impact and generate improved results.
One advantage of our collaborative efforts is being able to gather nearly all of Georgia’s 
resources and information related to cancer care in one place. In 2012, Georgia CORE created 
GeorgiaCancerInfo.org to catalog details on oncologists, clinical trials and treatment centers 
throughout the state, including resources and support services for survivors and caregivers, and 
best practices in survivorship care for oncology professionals.
As a result of the width, breadth and depth of our collaboration, Georgia CORE increases access 
to innovative cancer resources and research to improve quality of care for patients and quality 
of life for survivors. Our work ensures equitable distribution of programs and research to 
Georgia’s minority, rural and underserved populations across the state. 
We also raise awareness about survivorship issues, and educate and engage survivors to help 
them achieve their best possible quality of life. At the heart of these efforts is the Cancer 
Survivorship Connection, within GeorgiaCancerInfo.org, where an online library of resources 
and interactive tools provide support to survivors and anyone involved with their care.
Through partnerships with oncologists, researchers, nurses, educators, navigators and 
survivors, Georgia CORE leads impactful programs and clinical trials Funding from the National 
Cancer Institute, Patient Centered Outcomes Research Institute, Georgia Department of Public 
Health, Georgia Department of Community Health, Georgia Society of Clinical Oncology and 
others provides services, support, education and care in every corner of the state. Since the 
creation of our research network and statewide promotion of clinical trials, Georgia CORE has 
contributed to a seven-fold increase in the number of clinical trials in Georgia.
Hereditary Breast and Ovarian Cancer (HBOC) Genetic Testing Fund

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The Genetic Testing Fund was established by Georgia CORE in January 2014 to provide access 
to genetic testing for hereditary breast and ovarian cancer (HBOC) by underinsured Georgians. 
Genetics professionals around the state identified eligible individuals based on specific income 
and medical criteria including those at high risk for HBOC or a recent HBOC - related cancer 
diagnosis. Funded through the Breast Cancer License Tag Program, the Fund has provided 
support for 70 tests for underinsured Georgians, including 26 individuals with a recent cancer 
diagnosis, who would not have otherwise been able to afford testing with subsequent 
surveillance and management guidance.  For more information or to access the online 
application, visit: www.georgiacore.org/genetic-counseling.aspx.
Cancer Patient Navigators of Georgia
Georgia is one of the first states in the country to form a statewide multi-disciplinary 
organization for Cancer Patient Navigators. This organization was formed in 2009 to connect 
people who guide individuals and their families throughout the cancer care continuum. Cancer 
Patient Navigators of Georgia (CPNG) is comprised of individuals who serve people with all 
types of cancer, at all stages, in all types of settings, with a diversity of education and training, 
but one shared mission. The mission of CPNG is to connect, educate and share best practices 
among patient navigators in Georgia, as well as to successfully reduce barriers and increase 
access to services specifically related to cancer.
www.GACancerPatientNavigators.org has a “members only” section where cancer patient 
navigators across the state can share information and resources and join special interest groups 
within CPNG. Co-sponsored by Georgia CORE and the Georgia Society of Clinical Oncology 
(GASCO), CPNG has more than 275 members, including nurses, social workers and lay 
navigators.
In 2011, Tom and Karen Chapman contributed a $250,000 gift to expand patient navigation 
efforts in Georgia. To date, the gift has funded Georgia’s 1st Statewide Integrative Oncology 
Conference, a Lay Navigation Train-the-Trainer pilot program, a Lay Navigation Training 
Module, and a research grant for navigation.
25.0 Resources Available
The resources available to conduct the research are described in detail in section 24.0. 
26.0 Multi-Site Research*  
• N/A. 
27.0 References
1            Howlader, N. et al. SEER Cancer Statistics Review, 1975-2014, National Cancer Institute. 
Bethesda, MD. SEER Cancer Stat Facts: Kidney and Renal Pelvis Cancer 2017 (2017).
2
Norquist, B. M. et al. Inherited Mutations in Women With Ovarian Carcinoma. JAMA 
Oncology 2, 482, doi:10.1001/jamaoncol.2015.5495 (2016).

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3
Roberts, M. C. et al. Delivery Of Cascade Screening For Hereditary Conditions: A Scoping 
Review Of The Literature. Health Affairs 37, 801-808, doi:10.1377/hlthaff.2017.1630 
(2018).
4
Katapodi, M. C. et al. Cancer Predisposition Cascade Screening for Hereditary 
Breast/Ovarian Cancer and Lynch Syndromes in Switzerland: Study Protocol. JMIR 
Research Protocols 6, e184, doi:10.2196/resprot.8138 (2017).
5
Dheensa, S., Lucassen, A. & Fenwick, A. Limitations and Pitfalls of Using Family Letters to 
Communicate Genetic Risk: a Qualitative Study with Patients and Healthcare 
Professionals. Journal of Genetic Counseling 27, 689-701, doi:10.1007/s10897-017-0164-
x (2017).
6
Pozzar, R. A. & Berry, D. L. Patient-centered research priorities in ovarian cancer: A 
systematic review of potential determinants of guideline care. Gynecologic Oncology 147, 
714-722, doi:10.1016/j.ygyno.2017.10.004 (2017).
7
Williams, C. D. et al. Racial/Ethnic Disparities in BRCA Counseling and Testing: a Narrative 
Review. J Racial Ethn Health Disparities 6, 570-583, doi:10.1007/s40615-018-00556-7 
(2019).
8
Freedman, J. L. & Fraser, S. C. Compliance without pressure: The foot-in-the-door 
technique. 
Journal 
of 
Personality 
and 
Social 
Psychology 
4, 
195-202, 
doi:10.1037/h0023552 (1966).
9
Bastani, R., Maxwell, A. E., Bradford, C., Das, I. P. & Yan, K. X. Tailored Risk Notification for 
Women with a Family History of Breast Cancer. Preventive Medicine 29, 355-364, 
doi:10.1006/pmed.1999.0556 (1999).
10
Bowen, D. J. et al. Effects of a web-based intervention on women’s breast health 
behaviors. Translational Behavioral Medicine 7, 309-319, doi:10.1007/s13142-016-0439-
z (2017).
11
Brouwer, W. et al. Which Intervention Characteristics are Related to More Exposure to 
Internet-Delivered Healthy Lifestyle Promotion Interventions? A Systematic Review. 
Journal of Medical Internet Research 13, e2, doi:10.2196/jmir.1639 (2011).
12
Uy, C. et al. Text Messaging Interventions on Cancer Screening Rates: A Systematic 
Review. J Med Internet Res 19, e296, doi:10.2196/jmir.7893 (2017).
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