Prospective, Randomized Non-inferiority Trial of Streamlined Genetic Education and Testing for High-grade Epithelial Ovarian, Fallopian and Peritoneal Cancer Patients
Phase: NA
Conditions: Ovarian Cancer, Epithelial, Peritoneal Cancer, Fallopian Tube Cancer
Sponsor: Duke University

 
 
Protocol v 5.22.19 
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C4Protocol 
Prospective, randomized non-inferiority trial of streamlined genetic education and 
testing for high-grade epithelial ovarian, fallopian and peritoneal cancer patients 
 
Principal Investigator: Rebecca Previs, MD, MS 
 
Other Investigators:  
Andrew Berchuck, MD 
Brittany Davidson, MD 
Jinny Eun, MMSc 
Laura Havrilesky, MD, MHSc 
Noah Kauff, MD 
Paula Lee, MD, MPH 
P. Kelly Marcom, MD 
Leah McNally, MD 
Carolyn Menendez, MD 
Margaret Powell, MS 
Jatin Roper, MD 
Keelia Rhoads, PhD, MS 
Angeles Secord, MD 
Lindsay Soo, BA 
Catherine Watson, MD 
 
 
 
Institutional Affiliations: Duke University, Duke Cancer Institute 
 
 
 
 
 

 
 
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1.  Background 
Genetic testing in ovarian, fallopian and peritoneal cancers 
Genetic testing for hereditary cancer susceptibility gene mutations is a rapidly 
evolving science, complicated both by an increasing awareness of its pertinence and the 
assumed risks associated with genetic testing and results disclosure. The demand for 
testing in certain populations has risen in correlation to an increasing awareness of the 
genetic background of several cancers. In the case of high-grade epithelial ovarian, 
fallopian and peritoneal cancers, up to eighteen percent of these gynecologic cancers are 
secondary to BRCA1 and 2 mutations, and a further five to ten percent are secondary to 
other associated pathogenic mutations [1,2].  
Results of genetic testing may have profound implications for future family 
members, who can choose to undergo closer surveillance or prophylactic measures 
should they also carry a mutation [3]. Testing results can also impact patient treatment, 
as there now exist multiple FDA approved anticancer agents for BRCA mutations carriers 
[4-7]. For these reasons, current national guidelines, including the 2014 SGO Clinical 
Practice Statement and the NCCN guidelines version 2.2019 that all patients with ovarian, 
fallopian, or peritoneal cancer should be offered genetic testing [8,9]. 
The traditional model of genetic counseling 
 
Several societies, including ASCO and the National Society of Genetics Counselors, 
have provided guidelines for comprehensive patient education and informed consent 
prior to administration of testing [10-14]. These recommendations originate from the 
concept that the process of counseling and testing can be psychologically detrimental to 
patients and their family members and are grounded in a practice of non-directive 
counseling [12]. Fulfillment of these recommendations has traditionally been 
accomplished through face-to-face consultation with a genetic counselor prior to testing.  
 
During these consultations, patients receive approximately thirty to ninety 
minutes of in-depth education concerning their hereditary cancer risk and the 
implications of testing. This educational component of this process is exhaustively 
defined by ASCO’s elements of informed consent for genetic counseling, which upon last 
update contains sixteen separate discussion topics for multi-gene panel testing [14] 
[Figure 1].  

 
 
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Figure 1:  
Components of informed consent and pretest education in clinical cancer genetics [14] 
 
*Changes from the 2010 version include the discussion of multigene panel result management, discussion of batched 
genes rather than individual genes and acknowledgement of uncertain results and the high rate of VUS in multigene 
panel results.  
 
The critical components of the genetic counseling process include a medical and family 
history evaluation, cancer risk assessment, genetic education, discussion of testing, and 
arrangement of follow-up.   
Failure of the traditional model in ovarian, fallopian and peritoneal cancer patients 
 
Dependence on this model in the setting of universal testing recommendation, 
however, has several flaws.  The mutation rate is high enough and the implications of a 
positive mutation great enough to tip the risk and benefit ratio clearly to the side of 
testing. Thus, genetic counseling for the ovarian cancer population has undergone an 

 
 
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implicit shift from non-directive to directive. While the full ASCO pre-test counseling 
guidelines may still be appropriate in certain populations for whom universal testing has 
not been recommended by multiple professional societies, it seems reasonable to 
expedite the process for ovarian cancer patients.  
 
Second, the lack of consistent referral and limited supply of counselors associated 
with the traditional model, when combined with non-directive counseling, has resulted in 
a persistent failure to achieve universal testing, with approximately 25% of patients 
receiving BRCA1 and 2 testing [15,16]. The supply and demand issue will likely worsen, 
as genetic testing referrals for other solid tumors are also increasing in frequency. In 
short, the recommendation for universal BRCA1/2 testing in patients with high-grade 
epithelial ovarian, fallopian or peritoneal carcinoma has created a need for an alternate 
education and testing process.  
Alternative models of service delivery 
Several alternative models have been suggested, including group counseling, 
teleconferencing, telephone counseling and post-test counseling only [17,18]. More 
recently, the streamlined model has been successfully incorporated into several 
institutions through quality improvement initiatives [19,20]. In this model, the patients 
are counseled and testing at their primary oncologic appointment, either by the providers 
themselves or by embedded genetic counselors. These modifications have been shown to 
be easily implemented and to increase the institutions' counseling and testing rates by 
significant margins.  
Safety of alternative models 
While expedited models may increase efficiency and genetic testing uptake, it 
must be established that these methods are not detrimental to patients. ASCO and NSGC’s 
original policies regarding pre-test education originate from an effort to minimize patient 
distress. As reported in its policy statement on genetic counseling for cancer 
susceptibility mutations in 2003, “a definitive genetic test may have considerable medical 
and psychological implications,” and its counseling framework intends to prepare the 
patient for these [12].  
This assumption may not hold true, however, in the setting of more directive 
counseling, when the stakes for patients and family members are more significant. A 

 
 
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positive BRCA 1 or 2 result, logically, has been shown to have at least a temporary impact 
on psychological well-being, but this is present even after traditional pre-test counseling 
[21]. Multiple studies, however, have demonstrated that BRCA 1 and 2 testing in high-risk 
populations does not generally increase patient distress [22,23]. Furthermore, the use of 
certain alternate models to provide pre-test education, such as telephone counseling and 
teleconferencing, did not increase patient distress when compared to the traditional 
model [17,24].  Unfortunately, uptake of testing via telephone counseling was shown to 
be lower than that achieved by the traditional method in a prospective non-inferiority 
trial [17], and videoconferencing still requires possible over-utilization of genetic 
counselors in a pre-test setting.   
Purpose of study 
As evidenced by this discussion, a model that achieves the goal of increasing 
uptake and decreasing resource utilization while not significantly increasing patient 
distress has yet to be established. We hypothesize that a streamlined model of service 
delivery will not have a detrimental effect on patient distress with the counseling and 
testing process. We also hypothesize that this model will adhere to near-universal testing 
uptake without increasing cost burden on the healthcare system. This would be the first 
randomized trial to investigate the safety and non-inferiority of this promising new 
genetic service delivery model, providing an alternate, resource-effective method of pre-
test education that could improve genetic testing uptake without increasing adverse 
psychological effects.  
 
2. Study Objectives 
 
Primary Objective 
a. To determine if implementation of a streamlined model of genetic service delivery 
increases patient distress as measured by the Multidimensional Impact of Cancer Risk 
Assessment Scale when compared to the traditional model of counseling [25].  
 
Hypothesis: An expedited education and testing model in this patient population will not 
decrease patient satisfaction with genetic counseling or increase patient anxiety. 

 
 
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Secondary Objectives 
a. To compare cost between the traditional genetic counseling model and the streamlined 
model.   
 
Hypothesis: An expedited education and testing model in this patient population will be less 
expensive compared to the traditional model.   
 
b. To compare genetic testing uptake between the streamlined and traditional models.  
 
Hypothesis: In this study setting, both groups will have close to universal testing uptake.  
 
c. To observe differences in distress throughout the genetic education and testing 
process, including pre-education, post-education, and post-results disclosure. 
 
Hypothesis: The process of genetic education, testing and results review causes minimal 
distress in patients.  
 
3. Study Design 
3.1 Experimental Design 
This is a prospective, randomized non-inferiority trial.  
3.2 Study location 
This study will recruit from the gynecologic oncology clinics at Duke Cancer Institute and 
collaborating institutions. 
3.3 Study time period 
Estimated ascertainment completion date: 12/31/2020 
Estimated study completion date: 3/31/2021 
3.4 Study population 
The study will recruit from the gynecologic oncology clinic at Duke Cancer Institute and 
collaborating institutions. A maximum of 112 patients will be consented.  
 

 
 
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4. Study Procedure 
4.1 Subject Selection and Enrollment 
4.1.2 Inclusion and Exclusion Criteria 
Inclusion: 
• Age greater than 18 years 
• Female  
• Either a) pathologically confirmed diagnosis of high-grade epithelial ovarian, 
fallopian or peritoneal cancer via biopsy or surgical pathology or b) cytologic 
diagnosis consistent with high-grade epithelial ovarian cancer.  
• Presenting to Duke gynecologic oncology clinic or collaborating institution for 
first outpatient visit following pathologic or cytologic diagnosis.  If logistic 
constraints prevent the patient from being enrolled at her initial visit, she will be 
eligible for enrollment up to initiation of her fourth cycle of chemotherapy. 
 
Exclusion: 
• Known family or personal history of an inherited cancer susceptibility mutation 
• Previously received genetic counseling or testing for an inherited cancer 
susceptibility mutation 
• Insurance provided by an insurance company that requires face-to-face genetic 
consultation prior to testing 
• Unable to read or speak English as study design includes video assisted 
educational materials in English 
• Blind or deaf as study design includes video assisted educational materials in 
English 
 
4.1.3 Recruitment Procedures 
Recruitment 
 
 

 
 
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• Recruitment will occur in the gynecologic oncology clinics at Duke Cancer Institute 
and collaborating institutions.  
• Potential subjects will be identified by the primary research coordinator prior to 
their clinic visit and will be flagged for the primary provider, fellows, residents 
and APPs to make their potential eligibility for the trial known.  
Eligibility Determination and Introduction of Trial 
• Once the patient arrives in clinic, both the research coordinator and primary 
provider will review her eligibility for the trial based on the above stated criteria. 
• If eligible, either the primary research coordinator or provider will give a brief 
explanation of the trial and assess patient’s willingness to enroll.  
• If the patient agrees to enroll, the process of consent will begin. If the patient does 
not agree to enroll, a note stating that the patient was approached and then 
declined enrollment will be placed in the EMR so that she is not approached again. 
The patient’s basic demographic information will also be recorded in the secure 
online database for later comparison of demographic information between those 
who were amenable to alternative forms of service delivery and those who did not 
wish to participate.  
 
4.2 Process of Consent 
4.2.1 Consent Process 
• If the patient is amenable to enrollment, she will be consented in one of the clinic 
rooms in the gynecologic oncology clinic during her primary appointment by 
either the clinical research coordinator or her primary provider.  
• The IRB approved consent will be reviewed in full, including trial purpose, stated 
objectives, study procedures, risks, benefits, and costs. The consent process will 
take place in a clinic exam room with a closed door to ensure privacy.  
• Patients will have ample time while in clinic to ask questions of the research 
coordinator or gynecologic oncology provider. Up to thirty minutes will be allotted 
for review of consent form. If they have questions after their consent is signed, the 
contact information of the primary investigator will be listed in the consent form. 

 
 
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Subjects will be emailed a copy of the consent form once it is signed. If they do not 
have an active email account, a paper copy with their signature will be printed for 
them after they have signed the consent.  
4.2.2 Legal Capacity to Give Consent 
• The subject must have full capacity to consent. 
 
4.3 Risk and Benefit Assessment 
4.3.1  Risk 
• The first risk associated with this proposed study includes the use of secure 
medical records.  To ensure that patient confidentiality is maintained, all data 
retrieval will be performed by the principal investigator or assigned researchers 
using password-secured computers.  Each subject will be assigned a subject ID 
code that will be linked to the medical record number.  This will be generated 
using REDCap database and will be stored on a standalone database server hosted 
by Duke Health Technology Services (DHTS) and will only be accessible to the key 
personnel of this study. Collaborating sites will share the same Duke REDCap.  
• Risks of genetic testing will also be associated with the study, as a majority of 
patients in both arms will likely undergo testing. However, this is a risk associated 
with a separate, well-established standard of care in this population rather than 
with the study intervention. Thus, while it will be addressed with the patient when 
they complete their separate, standard consent for genetic testing, it is not 
considered to be an incremental risk of this study.  
• The study also incurs a potential incremental risk of adverse psychological 
reactions to streamlined genetic counseling and testing.  Our hypothesis is that the 
streamlined model will not significantly increase patient distress with the genetic 
counseling and testing process. 
 
4.3.2 Benefit 
• Patients will receive genetic risk assessment, which is currently recommended for 
everyone in this patient population. There is no other direct benefit provided to 

 
 
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subjects included in this study.  However, we hope that the findings of this study 
will lead to increase analysis and uptake of expedited models of genetic education 
and testing, thus potentially benefiting this patient population and their family 
members.  
 
4.3.3 Cost 
 
Charge of testing and face-to-face post-test counseling will be billed as per usual. 
 
The only incremental cost incurred by the participant will be the time spent 
 
participating in trial activities. Traditional pre-test counseling is not currently 
 
billed at Duke Cancer Institute, nor would the streamline education process be.  
 
4.3.4 Compensation 
• No compensation will be provided for participation in this trial. 
 
5. Study Design 
 
5.1 Randomization 
Following consent, the clinical research coordinator will randomize the patient to either 
the Traditional Group (TG) or Streamlined Group (SG). The randomization process will 
have occurred previously using the REDCap randomization tool.   
 
5.2 Study Procedures (See Figure One) 
5.2.1 Baseline Questionnaires (Both Groups) 
• 
After randomization, each subject will complete a series of baselines 
questionnaires on a tablet in the gynecologic oncology clinic, entering their results 
directly into the secure REDCap database. These baseline questionnaires include a 
basic numeracy test, the baseline anxiety and distress survey (IES) and the 
demographic information questionnaire, which will include questions concerning 
age, race, marital status, home address, and income [26,27].  
 
5.2.2 Tradition Counseling Group (TG) 

 
 
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a. Formal Consultation Scheduling 
• 
After completion of baseline surveys, the TG subjects will be referred to a formal 
pre-test consultation with a genetic counselor that will be scheduled for a date 
approximately 2-4 weeks after their primary appointment (for patients in whom 
results will determine treatment, appointments will likely be expedited).  They 
will be made aware of the date and time of this appointment prior to leaving their 
initial visit.  
b. Electronic Family History Questionnaire 
• 
TG subjects will complete an electronic family history questionnaire (FHQ) within 
one week of the primary visit. This is a system already employed by the Duke 
Clinical Genetics Department. An email is sent to the subject’s primary email 
account with a link to a secure, HIPAA compliant portal, in which the subject can 
then enter her family cancer history. 
• 
A member of the genetics team will curate the results by contacting the subject to 
review common errors and clarify any ambiguities in the pedigree.  
c. Formal Consultation and Post-Counseling Distress Survey 
• 
The TG subjects will then meet with the genetic counselor at the previously 
scheduled appointment time. During this visit, they will receive approximately 
thirty to sixty minutes of counseling regarding genetic testing and potential 
results. The discussion is based on the ASCO and NCCN guidelines of informed 
consent for genetic testing.  
• 
After counseling, participants will be given the option to undergo a multi-gene 
panel genetic test either via saliva or blood sample. Those who agree to testing 
will also complete the standard genetic testing consent form. As per standard 
practice of the clinical genetic service at DCI, patients will also be asked to provide 
consent for somatic tumor testing of surgical specimen (non-cytologic).  
• 
Subjects will complete a post-education distress and anxiety survey (IES) via an 
email link to a confidential REDCap survey link within one week of formal 
consultation.  
 
5.2.3 Streamlined Group (SG) 

 
 
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a. Video-Assisted Genetic Education 
• 
After completion of the baseline surveys, the SG subjects will watch an 
approximately eight minute long genetics education video. This video will be made 
with the assistance of Duke University genetic counselors and gynecologic 
oncology providers. It will consist of a discussion of genes and mutations, the 
recommendation of universal testing for high grade epithelial ovarian cancer, a 
review of genes associated with ovarian cancer predisposition, the possibility of 
uncertain results including variants of undetermined significance, the potential for 
undetected mutations in known or unknown cancer susceptibility genes, the 
potential impact on personal treatment and on family members, the possibility of 
genetic discrimination and the legal protection of genetic information. 
• 
After watching the video, the primary oncologic provider will then offer multi-
gene panel testing. 
• 
All subjects will then have the option to "opt out" and receive formal genetic 
counseling prior to making a decision about testing. 
• 
If the subject elects to undergo genetic testing, she will fill out the standard genetic 
testing consent form. As per standard practice of the clinical genetic service at DCI, 
patients will also be asked to provide consent for somatic tumor testing of surgical 
specimen (non-cytologic). 
b. Electronic Family History Questionnaire 
• 
SG subjects will complete an electronic family history questionnaire (FHQ) within 
one week of the primary visit. This is a system already employed by the Duke 
Clinical Genetics Department. An email is sent to the subject’s primary email 
account with a link to a secure, HIPAA compliant portal, in which the subject can 
then enter her family cancer history. 
• 
A member of the genetics team will curate the results by contacting the subject to 
review common errors and clarify any ambiguities in the pedigree.  
       c. Post-education distress measurement 
• 
Subjects will complete a post-education distress and anxiety survey (IES) via an 
email link to a confidential REDCap survey link within one week of formal 
consultation.  

 
 
Protocol v 5.22.19 
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5.2.3 Results Disclosure (Both groups) 
• 
Subjects will be notified of their results by the genetic counselor over the phone 
and triaged accordingly. 
o Deleterious mutation, VUS or high-risk family history despite negative 
genetic testing results: Scheduled for formal post-testing consultation 2-4 
weeks after result return 
o No deleterious mutation or VUS identified on genetic testing and low risk 
family history: No further genetics follow-up needed 
5.2.4 Follow-up 
• 
All subjects will take a satisfaction with genetic counseling survey (MICRA) after 
receiving results approximately seven days after either formal consultation or 
reception of results over the phone [25]. The survey will be sent via email via a 
confidential REDCap survey link.  
5.3 Outcome Variables 
5.3.1 Demographic information 
Measurement time: Baseline 
Description: Demographic information, including cancer history, age, race, marital status, 
and income will be collected from each participant upon enrollment. 
 
5.3.2 Numeracy assessment 
Measurement time: Baseline 
Description: Numeracy and health literacy will be assessed using the Newest Vital Sign 
survey, a six-question survey that asks questions about a provided ice cream nutrition 
label [26].  
 
5.3.3 Electronic family history 
Measurement time: A secure email sent to patient immediately after first visit; completed at 
home within one week of visit 

 
 
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Description: This is a system already employed by the Duke Clinical Genetics Department. 
An email is sent to the subject’s primary email account with a link to a secure, HIPAA 
compliant portal, in which the subject can then enter her family cancer history for three 
generations. A member of the genetics team will curate these results.  
 
5.3.4 Anxiety and depression  
Measurement time: Baseline, post-education and post-results disclosure 
Description: The Impact of Events Scale (IES) has been used widely as a means of 
measuring patient distress (particularly intrusive thoughts or avoidance) over a defined 
incident [27].  This evaluation will be used to identify trends in anxiety or depression in 
both arms throughout the education and testing process. In this trial, the "incident" will 
be described as "the risk of my cancer being hereditary." 
 
5.3.5 Distress  
Measurement time: Post-results disclosure 
Description: The multidimensional impact of cancer risk assessment questionnaire 
(MICRA) is a 25-question validated tool that measures the impact of result disclosure in 
patients, particularly markers of distress [25].  
 
5.3.6 Resource utilization 
We will evaluate the cost of physician, genetic counselor and genetic assistant time based 
on average base wages for these positions and total mean time spent by each of these 
providers. These estimates will be obtained for approximately forty patients –twenty 
from each arm – enrolled mid-trial to ensure that the process time in the streamlined 
group has reached full efficiency. Each provider will record time for each of these 
parameters using a stopwatch, with total times entered into the REDCap database.  
Times measured in both arms will include: 
Family History Curation 
 
GC phone time 
 
GC documentation or computer entry 
 
Staff phone time 

 
 
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Staff documentation or computer entry 
 
Pre test counseling (Any time prior to results disclosure) 
 
GC phone time 
 
GC documentation or computer entry 
 
GC face-to-face counseling  
 
Staff phone time 
 
Staff documentation or computer entry 
Post test (From time of results disclosure on) 
 
GC results disclosure phone time 
 
GC face-to-face counseling  
 
GC other phone time (not including results disclosure) 
 
GC documentation or computer entry 
 
Staff phone time 
 
Staff documentation or computer entry 
 
We will evaluate the cost of physician, genetic counselor and genetic assistant time based 
on average base wages for these positions and total mean time spent by each of these 
providers.  
5.4 Statistical Methods 
 
5.4.1 Demographic and Baseline Survey Information 
The SG and TG will be compared at baseline regarding demographic information, medical 
and family history and baseline distress as measured by the Impact of Events Scale. 
Categorical variables will be tested using the Chi-Square test. Continuous variables will be 
assessed using the Student T test or the Mann-Whitney U test for non-normal data. 
Equality of variance across these variables will be assessed. Any variables with a 
significant difference greater than p=0.1 will be controlled for in future analyses.  
 
5.4.2 Primary endpoint 
The study is powered as a non-inferiority analysis of distress associated with streamlined 
genetic education and testing versus traditional pre-test genetic counseling and testing.  

 
 
Protocol v 5.22.19 
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A two sample one-sided t-test is used to check the non-inferiority for the experimental 
treatment in terms of the MICRA (Multidimensional Cancer Risk Assessment 
questionnaire). We assumed the mean MICRA scores for both experimental arm and 
control arm will be the same and equal to 13.5, with a common standard deviation of 8.4. 
These values were obtained from a study that assessed the MICRA in a similar patient 
population [25]. Using these estimates, a total sample size of 102 (51 patients each arm) 
will provide 80% power to detect the non-inferiority for the experimental treatment with 
a significance level of 0.05 and a non-inferiority margin of 4.2 (50% standard 
deviation).  This margin was chosen as a high general MICRA score has previously been 
considered to be one standard of deviation above the mean; thus, we are taking a more 
conservative approach by using a non-inferiority margin of 0.5 the expected standard 
deviation observed in Cella et al [28].  When incorporating a potential 10% attrition rate, 
the total sample size will be 112.  
 
5.4.3  Secondary endpoints 
Resource utilization 
Mean resource utilization will also be compared between the two models using summary 
statistics.  
 
Genetic testing uptake 
Genetic testing uptake between the two groups will be compared using logistic 
regression.  
 
5.4.4 Exploratory endpoints 
Impact of Events Scale 
Mean changes in the Impact of Events Scale scores between each administration point 
will be compared between the two arms using the Wilcoxon rank sums test.  
 
5.5 Data and Safety Monitoring 
Subject safety will be maintained through use of only secure computers and networks for 
data collection and storage. Subjects will be assigned a new identifying number for 

 
 
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database organization purposes that will in no way be associated with any subject 
identifiers. The code list containing each subject’s new assigned number will be stored in 
RedCap database and on a standalone database server, hosted by Duke Health 
Technology Services (DHTS).  
 
5.6 The Role of External Personnel 
No external personnel will be involved in this study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Figure One: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Consent Process and 
randomization at outpatient visit 
Traditional Arm 
Streamlined Arm 
Results disclosure via phone 
Scheduling of formal consultation for a 
date 2-4 weeks after initial visit 
Baseline Questionnaires  
    -Demographic information 
    -Numeracy 
    -Impact of Events Scale 
Genetic testing offered 
Formal consultation with  
genetic counselor 
Genetic Team Results Review by 
Clinical Genetics Service 
      -FHQ 
      -Pathology 
       -Genetic testing results 
Baseline Questionnaires  
    -Demographic information 
    -Numeracy 
    -Impact of Events Scale 
Initial Visit 
Electronic Family History 
Questionnaire completion within one 
week following enrollment 
Electronic Family History 
Questionnaire completion within one 
week following enrollment 
Results 
Disclosure 
(Same steps in 
both arms) 
Post-Education Evaluation 
    -Impact of Events Scale via email  
    within one week after consultation 
Post-Education Evaluation 
    -Impact of Events Scale via email  
      within one week after FHQ  
Post-Visit 
Procedures 
Deleterious mutation, VUS or high-risk 
family history despite negative genetic 
testing results: Refer for formal 
consultation 
Negative testing: 
No need for further follow-up 
Identification of eligibility 
 
Genetic testing offered 
Blue Box Denotes 
Outcome Measurement 
Step 
Video-assisted genetic education 
*Subject may then opt out if desires 
formal consultation 

 
 
Protocol v 5.22.19 
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Post-Results Evaluation completed 
within 1 week after consultation 
         -Impact of Events Scale 
         -MICRA 
Post-Results Evaluation sent via email 
within 1 week after phone call  
         -Impact of Events Scale 
         -MICRA 

 
 
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