Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling
Phase: NA
Conditions: Breast Cancer
Sponsor: National Human Genome Research Institute (NHGRI)

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NHGRI IRB 
Human Subjects Research Protocol  
 
 
Project title: Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer 
Genetic Counseling 
 
Draft/version number (30, November, 2017) 
 
NHGRI Protocol Number: T-HG-0132 
 
Principal Investigator: Lori Erby ScM, CGC, PhD  
 
 
 
 
 
Title/Section/Branch/Institute: Staff Scientist/Social & Behavioral Research Branch/NHGRI 
 
IND/IDE reference number: N/A 
 
Collaborating Institutions: St. Luke’s Health System, Kansas City, Missouri (FWA00024002), 
Medstar Washington Hospital Center, Washington, DC (FWA00000504) 
List the name of the Site and FWA# for each institution; see 
http://ohrp.cit.nih.gov/search/asearch.asp#ASUR for assurance #s 
 
 
 

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Protocol Summary 
 
Full Title: 
Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian 
Cancer Genetic Counseling 
 
Principal Investigator:  
Dr. Lori Erby  
Sample Size: 
N= 74, patient control group =35, patient treatment group = 35, genetic 
counselors =4  
 
Accrual Ceiling: 
 
180 participants  
 
Study Population: 
Clients being seen for an initial visit in the hereditary breast and ovarian 
cancer (HBOC) clinic, both affected and unaffected with cancer, female, 
18-90 years-old 
 
Accrual Period: 
 
July 2017 – February 2017 
 
Study Design: 
 
This study is a feasibility study to assess the acceptance and initial 
outcomes of a self-affirmation intervention in a novel HBOC genetic 
counseling context. The study relies on surveys of 4 genetic counselors 
and 70 clients after a small case control study. The purpose is to estimate 
effect sizes and preliminary outcomes of self-affirmation in a genetic 
counseling setting and to assess client and counselor interest in self-
affirmation interventions. 
 
Study Duration: 
 
Start Date:  June 2017   
End Date:  March  2017 
 
Primary Objective: 
 
To identify outcomes that may be applicable for a larger SA intervention 
study in the genetic counseling context by randomly assigning clients to 
a control or intervention arm and then surveying them after the SA 
intervention and genetic counseling appointment. 
 
 
To assess clients’ and counselors’ opinions of an SA intervention by post 
study surveys. 
 
Secondary Objectives:  
To assess process outcomes of a SA intervention including the time 
required to complete the intervention, uptake, and attrition.  
 
 
Endpoints: 
 
Client’s completion of follow-up survey; Counselor’s completion of study 
review survey.  
 
 

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Contents 
Protocol Summary ........................................................................................................................ 2 
List of Abbreviations .................................................................................................................... 4 
1.0 
Precis ............................................................................................................................... 5 
2.0 
Objectives and specific aims................................................................................................ 5 
3.0 
Brief rationale and background ............................................................................................ 6 
4.0 
Description of study design ................................................................................................. 8 
5.0 
Description of procedures: .................................................................................................. 8 
6.0 
Description of study population ..........................................................................................11 
7.0 
Description of study statistical considerations and/or analytic plan: .........................................12 
8.0 
Description of potential benefits of study: ............................................................................13 
9.0 
Description of likelihood and seriousness of harms and how safety will be maximized: .............12 
10.0 
Description of how privacy and confidentiality of medical information/biological specimens will 
be maximized ..............................................................................................................................14 
11.0 
Assessment of risk/benefit ratio ..........................................................................................15 
12.0 
Unanticipated Problems:  Collection, monitoring, analysis and reporting of adverse events and 
protocol deviations ......................................................................................................................15 
13.0 
Description of alternatives to participation ...........................................................................16 
14.0 
Description of consent process ...........................................................................................16 
15.0 
Description of any financial compensation ...........................................................................17 
16.0 
References .......................................................................................................................18 
 
 
 
 

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List of Abbreviations 
 
AE 
 
Adverse Event/Adverse Experience 
AI 
Associate Investigator  
DSMB  
Data Safety and Monitoring Board 
FWA  
Federal Wide Assurance 
ICF 
 
Informed Consent Form 
IRB 
 
Institutional Review Board 
GC 
 
Genetic Counselor  
HBOC  
Hereditary Breast and Ovarian Cancer 
N 
 
Number (typically refers to number of subjects/sample size) 
NCI 
 
National Cancer Institute  
NHGRI 
 
National Human Genome Research Institute, NIH 
NIH 
 
National Institutes of Health 
OHRP  
Office for Human Research Protections 
OHSRP 
 
Office of Human Subjects Research Program 
PI 
 
Principal Investigator 
SA 
Self-Affirmation 
SAE 
 
Serious Adverse Event/Serious Adverse Experience 
SI 
 
Student investigator  
SOP 
 
Standard Operating Procedure 
UP 
 
Unanticipated Problem 
UPnonAE 
Unanticipated Problem that is not an Adverse Event 
 
 
 

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1.0 
Precis 
The proposed study is a feasibility study to assess the viability of implementing a Self-
Affirmation (SA) intervention in a Hereditary Breast and Ovarian Cancer (HBOC) 
genetic counseling clinic to improve client communication and behavioral outcomes. 
Participants will be clients and genetic counselors at the St. Luke’s Hospital System and 
Medstar Washington Hospital Center HBOC clinics. This study seeks to identify 
outcomes that would be most informative in a large-scale research protocol. As 
outcomes, we will assess clients’ decision self-efficacy, intention to talk with family, 
genetic test uptake, empowerment, and HBOC knowledge. We will also assess 
counselors and clients perceived benefits, perceived harms, and acceptance of the 
affirmation intervention.  
In this study clients will be invited to participate in an intervention before their genetic 
counseling appointment. The SA intervention is a short written exercise to reinforce 
clients’ self-integrity (a global sense of personal adequacy), leading to more openness to 
threatening information within the genetic counseling session. Clients and counselors will 
be surveyed after the study to assess outcome measures and feasibility of the intervention.  
Social science research has shown that when people are faced with threatening 
information they often seek to protect themselves and reject the threatening message. 
Message rejection can include minimizing the importance or discrediting the truth of the 
message. SA interventions aim to bolster self-integrity by focusing on aspects of 
subject’s lives they value and thereby improving participants’ self-perception and 
tolerance towards threatening messages. SA manipulations have been shown to increase 
patient communication within appointments and both intentions and actions toward 
behavior change.  
Often in cancer genetic counseling appointments clients are confronted with the threat of 
having a significantly increased risk of cancers while being asked to make a decision 
about genetic testing. A self-affirmation intervention may facilitate greater client decision 
self-efficacy, empowerment, and positive behavior outcomes, such as communication 
with family regarding genetic risk and screening behaviors.  
2.0 
Objectives and specific aims  
 
The objective of this study is to investigate if a self-affirmation intervention is feasible in the context of 
HBOC genetic counseling appointments. 
 
Specific aims 
1. To assess the preliminary impact of a SA intervention on outcomes that may be implemented in 
future studies, by assessing differences in the following between a SA intervention and 
unaffirmed standard SA control group of HBOC genetic counseling clients:  
a. Intentions to talk with family, test uptake 
b. Empowerment, decision self-efficacy 
c. HBOC knowledge 
2. To describe genetic counselors’ (GCs) and clients’ response to a novel, client-based SA 
intervention, including perceived impact, barriers, and facilitators to implementing such an 
intervention on a wider scale  

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3. To assess the percentage of eligible clients that completed a pre-visit SA intervention and if the 
SA intervention is effective in affirming clients.  
 
3.0 
Brief rationale and background 
 
 
Breast cancer is the most prevalent cancer in women, with 230,815 new diagnoses in 
women in 2013 alone (U.S. Cancer Statistics Working Group, 2016). It is estimated that 5-10% 
of women with breast cancer and 20% of women with ovarian cancer carry a gene variant that 
predisposes them to these cancers (Campeau et al., 2008; Walsh et al., 2011). Being at genetic 
risk for cancer means clients often face difficult decisions about testing, conversations with 
family members, prophylactic surgery, and preventative medications. As more people are faced 
with these decisions it is important to understand how to best aid them in the decision-making 
process. Self-affirmation has shown to increase patient engagement and problem solving. This 
proposed study is a feasibility, randomized control trial to assess the initial outcomes of self-
affirmation and the openness of genetic counselors and clients to an intervention for improving 
clients’ genetic counseling experiences and outcomes.  
Self-affirmation.  
Self-affirmation (SA) theory suggests that people work to maintain their perceptions of 
self-integrity, morality, and consistency (Sherman & Cohen, 2006; Steele, 1988). When they 
experience a threat to the self-concept they seek to neutralize it through defending themselves 
against the message. Self-integrity is an individual’s perception of their efficacy across multiple 
domains, defined further as their cumulative moral and adaptive adequacy (Steele, 1988). Self-
integrity can be best understood in context. For example, a woman may feel threatened by a 
negative health finding, but if she feels competent in her relationships, then her overall self-
integrity is likely to be maintained and she can address the threat in a non-defensive manner. On 
the other hand, when self-integrity is compromised, and other areas of self-concept do not 
stabilize the threat, then individuals can become defensive against the threating message to 
protect their self-integrity (Sherman & Cohen, 2006; Steele, 1988). For example, they may try to 
discredit or ignore a concerning message.  
SA theory further postulates that an affirmation intervention prior to facing a threat can 
reinforce an individual’s self-integrity and increase openness to the threat (e.g., a threatening 
message or performance in a difficult task; Sherman & Cohen, 2006). SA has also been shown to 
increase openness to threatening health messages. In one study, 66 women were given an article 
stating that coffee consumption increases the risk for fibrocystic breast disease (Reed & 
Aspinwall, 1998). Half of the women were given a self-affirmation measure focusing on 
kindness before reading the article. Those who drank coffee and were self-affirmed oriented to 
and accepted risk confirming information significantly more quickly than did coffee drinkers 
who were un-affirmed. Other studies have shown similar results related to accepting threatening 
health messages (Harris & Epton, 2009).  
Specific to genetic information, SA has been shown to improve openness. One survey of 
594 participants in the ClinSeq cohort found that those who were higher in spontaneous self-
affirmation were more likely to intend to seek out genetic risk information despite being high in 
anticipated affect, a correlate for worry (Ferrer et al., 2014). SA may affect people’s desire for 
genetic test results. SA may increase clients’ likelihood to talk with family members about 
genetic information. Not telling relatives could have negative outcomes for at-risk family 
members. Ferrer and colleagues’ (2014) ClinSeq research found that those who were higher in 
spontaneous SA were significantly more likely to intend to share actionable genetic testing 

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results (p = 0.05) and non-actionable results (p = 0.01) with family members. Although 
spontaneous SA is distinct from prompted SA, this finding could suggest that an intervention 
would also increase discussions with family members. Additionally, SA interventions have been 
shown to significantly increase participants’ feelings of love and connectedness to others 
compared to a control group, which may also be related to intentions to talk with family 
(Crocker, Niiya, & Mischkowski, 2008). 
SA has also been shown to improve problem solving in stressful situations. A case-
control study of 73 university students found that chronically stressed students who were self-
affirmed before a remote associate problem-solving task (RAT) performed better than those who 
were chronically stressed and unaffirmed (Creswell et al., 2013). Both the main effect of SA (p = 
0.005) and the interaction effect between chronic stress and SA (p=.041) were significant. 
A meta-analysis of SA and responses to health messages assessing both intentions and 
behaviors in 16 studies found that aggregate effect sizes for health intentions and health 
behaviors were statistically significant but low at d = 0.26 and d = 0.27 respectively (Sweeney & 
Moyer, 2015). Behaviors and health intentions in this study were both negative (e.g. reducing 
caffeine intake or alcohol consumption) and positive (e.g. increasing sunscreen or condom use). 
It should be noted that 12 of the 16 studies reviewed used student samples where the threat was 
either far off (e.g. sunscreen use and skin cancer) or not personalized so the perceived threat of 
the message may have been low. In the proposed study the risk for HBOC cancer is personalized 
by family history or personal early onset cancer and the threat of cancer is either immediate or 
high. Since stress and heightened risk appraisals appear to moderate the effect of SA as an 
intervention, we would expect the effect of SA in this population to be higher than those in the 
meta-analysis.  
Other studies have addressed SA and client engagement in a medical encounter. A 
randomized controlled trial of SA in African American clients with hypertension found that the 
SA treatment group requested and provided more information about their medical condition from 
their primary care provider in a medical encounter. Additionally, in the SA group, the patient-
provider communication was characterized as being more interested, friendly, responsive, 
interactive, and respectful (Havranek et al., 2012). Since SA is postulated to increase message 
acceptance and to decrease motivation to avoid the threat, it is consistent that clients may attend 
to the threatening message more carefully and remember information about HBOC more 
accurately (Harris & Epton, 2009).  
SA is postulated to decrease patient defensiveness. To our knowledge there are no direct 
measures of patient defensiveness but this construct has been assessed by measuring numerous 
downstream constructs in past research, including perceived threat, message acceptance, and 
defensive avoidance (Good & Abraham, 2007). In this study, we will be measuring the 
downstream effects of defensiveness by assessing patient empowerment and decision efficacy. 
SA intervention are theorized to decrease patient defensiveness, which will increase their 
openness to threatening information, which will increase decision self-efficacy. Furthermore, 
increased openness will increase the client’s engagement in the genetic counseling session and 
result in greater patient empowerment. It is also possible that client self-integrity, their global 
sense of personal adequacy, is related to empowerment more directly than outlined above.  
Feasibility study  
To our knowledge studies have not examined the impact of SA interventions in genetic 
counseling (Etchegary & Perrier, 2007). The ClinSeq study, designed to identify health-related 
genetic changes through exome sequencing, examined SA related to genetic risk perception and 

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information seeking. Although the ClinSeq study did not include a SA intervention, surveys did 
include assessments of participants’ tendencies to engage in spontaneous SA.  
Given the lack of evidence in this context it is important to conduct a feasibility study 
prior to a full-scale intervention to assess genetic counselors’ and clients’ reactions to the SA 
intervention, and the logistics of and barriers to SA implementation. Feasibility research studies 
generally have smaller sample sizes and therefore statistically significant outcomes are not 
expected. These studies allow for exploration of many aspects of implementation and 
preliminary outcomes. The National Cancer Institute has recognized the need for more 
intervention-based feasibility studies prior to full-scale studies to determine “whether 
comprehensive and multilevel evaluations are justified (Bowen et al., 2009, p. 1).” A feasibility 
study of SA in genetic counseling would allow for preliminary examination of the impact of SA 
on genetic counseling session outcomes to provide estimates of effect size, confidence intervals 
and, consequently, necessary sample size for a future study. 
4.0 
Description of study design  
This study is a randomized controlled feasibility study to assess the acceptance and initial 
outcomes of a self-affirmation intervention in a cancer genetic counseling context. 
5.0 
Description of procedures:  
In this intervention-based randomized controlled feasibility study, Hereditary Breast and 
Ovarian Cancer (HBOC) genetic counseling clients will receive an intervention and short survey 
before their appointment and will complete a survey after their appointment. Genetic counselors 
who counsel participating clients will complete a post-appointment survey after each 
appointment with a participating client and a survey at the end of the study.  
Thirty-five client participants will be randomly assigned to complete the self-affirmation 
intervention and 35 participants will complete the control condition. Client participants will be 
patients being seen for an initial appointment for genetic counseling at the HBOC genetic 
counseling clinic, regardless of current cancer status. All client participants will take a state 
anxiety measure before their appointment to control for some of the variability in indication. 
Client participants will also indicate if they have cancer, if they have received genetic testing, 
and if they were offered genetic testing at the current visit. Genetic counseling can be indicated 
for patients without cancer who have a family history of cancer, for patients with cancer, and for 
self-referred patients who are concerned about their cancer risk. Most often, the initial cancer 
genetic counseling appointment occurs before qualification for genetic testing is assessed and 
clients have a follow-up appointment to receive results. Sometimes oncologists or primary care 
physicians order genetic tests and the initial genetic counseling appointment includes results 
delivery and education. Any client with an initial genetic counseling appointment will be invited 
to participate in the study. Follow-up appointments will not be included because patients already 
have a relationship with the genetic counselor.  The four genetic counselors, who have 
appointments with the participating clients, will be enrolled in the study as genetic counselor 
participants.  
The SA intervention consists of participants ranking 11 items (artistic skills, athletics, 
business/money, creativity, independence, music, politics, relationships with friends and family, 
religious values, sense of humor, spontaneity) from most important to least important (See 

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Appendix C) (Creswell et al., 2013; Havranek et al., 2012). They will then be asked to write 
about the item that is most important to them and why it may be important to them. The control 
group will rank the same list and be asked to write about the 9th ranked item and why it might be 
important to someone else.  The control condition is consistent with the control used in other SA 
intervention studies. The 9th ranked item is chosen to inhibit a reverse effect where participants 
feel affirmed because they do not value something that is averse to them. Both the intervention 
and control group will receive a 6-question survey of state anxiety along with the writing prompt, 
which will be used as a control measure. 
Potential participants will be identified through the patient schedule and will be contacted 
by the student assistant investigator (AI), Anna Chassevent, about one week prior to their 
appointment to invite them to participate in the study and obtain verbal informed consent. 
Participants will be recommended to arrive 15 minutes prior to their scheduled appointment. 
When clients arrive at the HBOC clinic, the front desk staff will give client participants the SA 
or control intervention based on random assignment.  The affirmation intervention or control 
condition will be completed directly before the regularly scheduled appointment.  
 
Genetic counselors will be blinded to the study condition of their clients, although clients 
might choose to discuss the content of the intervention survey with the counselor. Counseling 
sessions will otherwise proceed according to protocol for the clinic. Clients will receive a paper 
survey as they leave the appointment regarding their demographic information (age, sex, 
education, race, ethnicity, cancer status) experience in the study, decision self-efficacy, 
empowerment, genetic knowledge, intentions to talk with family, information seeking, and 
intentions to pursue genetic testing if it was offered. They will be given the option to fill out the 
paper version or to access an electronic version online. Hard copy surveys will be returned to the 
front desk or by mail to the AI. Electronic versions will be sent to an email address provided by 
the client. A week after their appointment, all clients will receive an electronic reminder 
notification to complete the questionnaire. Upon completion of the online survey or paper 
questionnaire participants will be mailed a $15 gift card.  
Genetic counselors at St. Luke’s Health System volunteered to participate in this study 
and contacted the AI about their interest in participating and hosting the study. The counselors at 
Medstar Washington Hospital Center were contacted by the AI after initial IRB approval of this 
protocol in order to increase recruitment by adding an additional site.  
At the onset of data collection, counselors will complete a written consent. After each 
appointment with a study participant, genetic counselors will complete a short client 
empowerment survey. After the client study is complete, genetic counselors will be given a 
survey about their opinions about and experience with the self-affirmation intervention. 
Questions will include information on their experiences and opinions about the SA. Counselors 
at St. Luke’s Health System will each be given a $1400 gift card at the completion of the latter 
questionnaire. The counselors at Medstar see fewer potential participants so their compensation 
will be $200. We expect to have approximately 16 patient participants from Medstar and 54 from 
St. Luke’s Health System. In addition, the counselors at MedStar will be involved with 
recruitment over a shorter period of time and will not have to expend the effort expended by the 
St. Luke’s counselors to work through logistics prior to the study’s approval 
 

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Figure 3: Participants participation in protocol 
Responsibilities of NIH  
This study was developed by the student associate investigator, Anna Chassevent, for her 
thesis project as a part of the Genetic Counseling Training Program at the NHGRI and her thesis 
advisor, Dr. Barbara Biesecker at the NIH. Clients will be consented for participation by phone 
by the SI. Counselors will be consented by email or fax by the AI. The AI will distribute the 
study materials (intervention and surveys) to the counselors at St. Luke’s Health System and 
Medstar Washington Hospital Center. All data will be analyzed at the NIH by the PI and AI, who 
are researchers from the NIH.  
 
Responsibilities of St. Luke’s Health System and Medstar Washington Hospital 
Center 
Whitney Ford and Kallie Woods are genetic counselors at St. Luke’s Health System and 
non-NIH collaborators for this research study. The St. Luke’s Health system HBOC scheduling 
coordinator will distribute and collect the intervention, client surveys, and contact cards on site at 
the St. Luke’s health system HBOC clinic. The scheduling coordinator will also collect the 
genetic counselor after visit and end of study surveys. They will mail all deidentified materials to 
the NIH researchers for analysis. 
Michael Setzer and Aime Agather are the genetic counselors at Medstar Washington 
Hospital Center and non-NIH collaborators for this research study. Similarly to St. Luke’s Health 
System, the front desk personnel will distribute and collect the study intervention, client surveys, 

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and contact cards. Because this clinic does not have one assigned clinic coordinator, the 
counselors will confirm and oversee that study materials are appropriately returned to the AI.  
The intervention and client survey will not include identifying information and contact 
information will be separated from the other study materials. All surveys and the intervention are 
self-administered.  
 
5.1 
N/A 
5.2 
N/A 
5.3 
N/A 
5.4 
N/A 
5.5 
N/A  
5.6 
Describe questionnaires or other psychological instruments and estimate how long 
they will take to complete, and whether they address sensitive topics (Appendix 
C-F) 
Intervention (See appendix C) 
For the SA intervention, participants will be asked to rank 11 items (artistic skills, 
athletics, business/money, creativity, independence, music, politics, relationships with 
friends and family, religious values, sense of humor, spontaneity) from most important to 
least important (Creswell et al., 2013; Havranek et al., 2012). They will then be asked to 
write about the item that is most important to them and why it may be important to them. 
The control group will rank the same list and be asked to will write about the 9th ranked 
item and why it might be important to someone else.  The control condition is consistent 
with the control used in other SA intervention studies.  
Immediately after the intervention or control condition, participants will complete a 2 
minute survey that consists of the short version of the Stat-Trait Anxiety Inventory 
(STAI). This measurement entails 6 questions to assess the client’s current anxiety. The 
purpose of the STAI is to control for anxiety, to identify if those who are more anxious 
are more effected by the SA intervention. The intervention and STAI should take about 
10-15 minutes together. At the end of the intervention there will be a detachable page 
asking for the client’s email address to send them with the post-intervention survey and a 
reminder to complete it. This document will be immediately separated from the study 
material by the scheduling coordinator.  
 
Client post-intervention survey (Appendix D) 
Client surveys will consist of questions on each category of outcome (information 
seeking, test uptake, empowerment, intention to talk with family, decision self-efficacy, 
and HBOC knowledge) as well as response to and acceptance of the SA measure. The 
survey will be offered online and in person. It should take less than 15 min for 
participants to complete. At the end the hard copy post-intervention there will be a page 
for clients to enter their mailing address to receive the gift card, this page will be 
immediately separated from the other study materials by the scheduling coordinator. The 
online survey will have a separate link for clients to enter their mailing address.  

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Decision self-efficacy. To measure decision self-efficacy in decisions regarding genetic 
testing for HBOC and we will use the Decision Self-Efficacy Scale (O’Connor, 1995). 
This scale focuses on the decision process and interactions with the medical professional 
so it gives insight into both decisional efficacy and clients’ engagement with the 
clinician.  
Test uptake.  For this section we will ask two questions to test uptake; “Did your 
counselor offer you genetic testing in your counseling appointment?” (yes/no) and “If 
yes, do you plan to have genetic testing?” (yes/no).  
Intention to talk with family. Intention to talk with family will be measured using two 
questions. The first is a question asking clients to select the categorical description of the 
family group they are most likely to share information with from a list of options, such as 
“I plan to talk to only a few people who are closest to me.” The second question will state 
“How likely are you to share results with the relatives you selected?” will be rated on a 1-
7 likert scale labeled “extremely likely to extremely unlikely.”  
Empowerment. Empowerment will be assessed using the valid and reliable Genetic 
Counseling Outcomes Survey (GCOS-24) (McAllister et al, 2011). The GCOS-24 is a 24 
item instrument that was designed to measure positive outcomes of genetic counseling. 
Empowerment was conceptualized to include decisional control, cognitive control, 
behavioral control, emotional regulation, and hope. The scale has seven dimensions, 
which exist under a single higher order construct.  
Client Knowledge. Client knowledge will be measured using modified questions based 
on the National Center for Human Genome Research Knowledge scale and genome 
sequencing knowledge items from Kaphingst and colleagues study of informed consent 
on genome sequencing knowledge (Kaphingst et al., 2012; Scherr, Christie, & 
Vadaparampil, 2015). These questions focus on the main knowledge concepts rather than 
specific details since counseling sessions may differ depending on patient’s indication for 
genetic counseling.  
Response to SA measure. This section will ask both open ended and yes/no questions 
regarding clients’ acceptance of and response to the intervention or control. There is also 
a question asking if and how clients thought that the measure affected their counseling 
session to identify any overt interference of the measure with their session.  
 
Counselor after visit survey (Appendix E) 
The counselor after visit survey consists of a counselor version of the Genetic Counseling 
Outcome Scale (GCOS-24). This scale was modified from the original GCOS-24 for use 
by counselors and parallels the client version.  This measure consists of 24 likert scale 
questions that assess counselor’s perceptions of the client’s empowerment. It should take 
3-5 minutes for the counselors to complete after each session.  
Counselor post-study survey (Appendix F) 
The counselor post-intervention surveys will include four yes/no questions with related 
open-ended response questions regarding the intervention. It also includes one likert 
scaled question and a place for any other thoughts on the study. This survey should take 
about 10 minutes to complete.   
6.0 
Description of study population 

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6.1 
Estimated number of participants, enrollment ceiling, and anticipated enrollment 
by year. 
The client participants will be female patients being seen at the high-risk breast and 
ovarian cancer clinic at St. Luke’s Health System and Medstar Washington Hospital 
Center, for their initial appointment for genetic counseling for HBOC. Participant 
selection will be indiscriminant of if they have cancer or if they have already had genetic 
testing through another provider. Participants must be at least 18 years of age. For a fully 
powered study of the effect of self-affirmation on genetic counseling outcomes, we 
estimate that we would need 296 participants to identify a small to medium effect 
(Cohen’s d = 0.35) with beta being 0.85 and alpha being 0.05. This Cohen’s d is based on 
other SA interventions in the education and emerging medical literature. For this 
feasibility study we seek to recruit 70 client participants and 4 genetic counselor 
participants. We chose this number for several reasons. The genetic counselors at St. 
Luke’s Health System see about 40 new patients a month. Over the 4 months of data 
collection there will be 180 appointments. We believe that getting 70 of these clients to 
consent is an achievable estimation. Additionally, feasibility studies typically range from 
30-50 participants to estimate attrition and confidence intervals. The enrolment ceiling is 
180 participants. Genetic counselor participants two genetic counselors at the St. Luke’s 
health system HBOC clinic. Participants will be enrolled by February of 2018. To this 
point, we have been recruiting about 8 patients a month instead of expected 17 through 
St. Luke’s Health System. To our knowledge, this is because the counselors are seeing 
more colorectal and other cancer patients then expected instead of HBOC patients and we 
have been able to reach less patients for consent. About half decline to be contacted and 
1/3 cannot be reached by the AI for consent. For this reason, we are adding the Medstar 
Washington Hospital Center site and extending the recruitment window.  
Genetic counselor participants are two genetic counselors employed in the HBOC genetic 
counseling clinic at St. Luke’s Hospital and two genetic counselors who see HBOC 
patients at Medstar Washington Hospital Center.  
6.2 
Description and justification of clinical inclusion/exclusion criteria.  
Participants must be female, at least 18 years old, and have an initial appointment for 
genetic counseling for HBOC risk at St. Luke’s health system or Medstar Washington 
Hospital Center. Participants will not be discriminated against for race, ethnicity, or 
income. Participants must be able to read and write in English to participate. Non-English 
speakers and illiterate subjects will be excluded. The intervention and measures have not 
been validated in other languages and therefore we are limiting the language to English. 
We will assess feasibility before validating the measures and intervention in another 
language. Since this is a feasibility study we will not have sufficient power to validate the 
measures. Follow-up studies should include more diverse populations. Clients who are 
unable to provide consent will be excluded. Pregnant women will be included. This is 
appropriate under 45 CFR 46.204 because this is minimal risk research necessary to 
develop important knowledge that cannot be obtained by other means. It will be the case 
that: 1) no inducements, monetary or otherwise, will be offered to terminate a pregnancy; 
2) individuals engaged in the research will have no part in any decisions as to the timing, 
method, or procedures used to terminate a pregnancy; and 3) individuals engaged in the 
research will have no part in determining the viability of a neonate. 

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 The study will be limited to women because the majority of clients at a hereditary breast 
and ovarian cancer clinic are women and we do not estimate that there will be enough 
male clients to independently analyze their responses. 
Genetic counselor participants must be certified genetic counselors and see clients with 
an indication for HBOC related genetic counseling.  
6.3 
Location of study. 
This study will be conducted at the HBOC clinics at St. Luke’s Health System in Kansas 
City, Missouri and Medstar Washington Hospital Center in Washington, DC.  
6.4 
Description of recruitment strategies. 
Participants will be identified through the scheduling system at St. Luke’s Health system 
HBOC clinic. The scheduling coordinator will identify participants on the schedule who 
may meet criteria for the study. During the routine reminder call to patients the 
coordinator will ask clients if they are willing to receive a phone call regarding a study. If 
clients agree the AI will contact clients to explain the study, identify clients interest, and 
complete the informed consent. Clients will also be sent an information leaflet (See 
appendix G) about the study in the pre-appointment packet that is sent to all clients to 
provide informed about the study before the AI contacts them.  
Recruitment will occur in a similar fashion at Medstar Washington Hospital Center 
although the clinic does not have a single clinic coordinator. For this reason, the 
counselor will oversee the identification of participants who may qualify for the study. To 
minimize conflict of interest, clinic personnel other than the genetic counselors will then 
call the potential patient participants to seek permission for them to be contacted by the 
AI. If they agree, the AI will contact them in the same manner as at St. Luke’s Health 
system. 
Genetic counselor participants at St. Luke’s Health System were contacted for interest in 
hosting the study through the National Society of Genetic Counselors cancer Special 
Interest Group (SIG). The two counselors at St. Luke’s Health system voluntarily 
contacted the AI to both assist with this research at their site and to participate. The 
counselors at Medstar Washington Hospital Center were contacted by the AI after initial 
IRB approval in order to increase recruitment by adding an additional site. 
6.5 
Description of criteria for withdrawal from study. 
Client participants may withdraw from the study at any time during or immediately 
following completion.  While completing the survey, the participant may choose not to 
answer any particular question. Surveys will be anonymous, using a code word to 
coordinate documents (see Section 10) and never linked to contact information. If client 
participants request to withdraw from the study if they must provide their code word to 
identify and remove their documents.  
Genetic counselor participants may with withdraw from the study at any time during the 
study. If genetic counselor participants withdraw any previous surveys will be included in 
the analysis but future patients will not be consented to participate. Surveys will not be 
linked to the individual counselor.  
7.0 
Description of study statistical considerations and/or analytic plan: 
Aims have been copied here for ease of interpretation.  

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Aim 1: To assess the preliminary impact of a novel SA intervention on outcomes that may be 
targeted in future studies, by assessing differences in the following between a SA intervention 
and unaffirmed standard SA intervention control group of HBOC genetic counseling clients:  
a. Intentions to talk with family, test uptake 
b. Empowerment, decision self-efficacy 
c. HBOC knowledge 
The primary goal of analysis of aim 1 is to identify which outcomes would be most 
appropriate for follow up studies and the necessary sample size for adequate statistical 
power.  
 
For decision efficacy, the scores on the Decision Self-Efficacy Scale (See section 2 of client 
survey, Appendix D) will be compared between groups using linear regression controlling 
for education, race, anxiety score, and effectiveness of intervention (based on last question on 
intervention Appendix C). Intention to talk with family, genetic testing uptake, and 
information seeking will be measured similarly using linear regression. 
 
Client empowerment will be analyzed by using the GCOS-24 a 24-item likert scale 
completed by clients and parallel scale by genetic counselors (See section 3 of client survey 
of appendix D and appendix F). Both scales will be compared between groups using linear 
regression controlling for education, race, anxiety score, and effectiveness of intervention 
(based on last question on survey). Discrepancies between counselor and client surveys will 
be analyzed using dyadic analyses. For this analysis, we will assess the correlation between 
paired client and genetic counselor GCOS-24 for the compete survey and for the individual 
questions.  
 
HBOC knowledge will be analyzed between groups using linear regression testing the 
knowledge scale (See section 4 of client survey, Appendix D) and controlling for education, 
race, anxiety score, and effectiveness of intervention.   
 
Effect sizes and standard deviations for each outcome will be identified, and an estimated 
sample size for a fully powered study will be estimated based on power calculations. 
  
Aim 2: To describe genetic counselors’ (GCs) and clients’ response to a novel, client-based 
SA intervention, including perceived impact, barriers, and facilitators to implementing such 
an intervention on a wider scale 
 
This aim will be analyzed as percent of yes/no response to intervention survey questions for 
both clients and counselors. There will also be open ended questions for specific impacts, 
barriers, and facilitators to be mentioned, which will be analyzed using thematic analysis of 
answers. The AI will create a codebook based on initial read through and subsequently code 
all answers. A separate coder will validate ten percent of answers for consistency.  
 
Aim 3: To assess the percentage of clients that completed a pre-visit SA intervention among 
client participants and if the SA intervention is affective in affirming clients.  
 

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Intervention uptake will be reported as a percentage of participants who were eligible based 
on counselor referral and who were contacted by AI that completed the SA intervention and 
client survey.  Effectiveness of affirmation is an internal control and will be assessed by 
screening the last question on the intervention for those in the intervention group who report 
higher than a 2 and those in the control group who report lower than a 5. Additionally, 
transcripts of intervention essays will be analyzed for affirmation themes.  
8.0 
Description of potential benefits of study:  
8.1 
Direct benefits to participants 
There are minimal direct benefits to participants. Client participants in the intervention 
group may benefit from a richer counseling experience through greater openness and 
exploration of values if the intervention is successful.  
8.2 
Collateral benefit to participants  
A collateral benefit that could result from this study is that those in the self-affirmation 
group may be more likely to spontaneously self-affirm in future situations after engaging 
in the SA measure (Brady et al, 2016).  
8.3 
Benefits to society 
This study could benefit society by building on our knowledge about which outcomes are 
subject to SA. It could also enlighten counselors on ways to engage clients in a genetic 
counseling session. Furthermore, the feasibility study can give information about possible 
barriers to other similar interventions delivered prior to a genetic counseling visit.  
9.0 
Description of likelihood and seriousness of harms and how safety will 
be maximized: 
This study is unlikely to cause serious harms. There is small chance that there could be low 
level psychological harm caused by this study because SA has been shown to increase 
openness to a threatening message and therefore increase feelings of vulnerability and 
possibly anxiety (Klein et al., 2011). While this may occur among participants in the 
intervention arm, the magnitude of the risk is likely small and will be mitigated by the fact 
that they will be seen by genetic counselors who have training to manage clients’ anxiety. 
There also could be benefit to increasing anxiety in a situation where action needs to be taken 
to avoid a threat, such as continuing recommended screening for early detection of breast 
cancer. There is no increased risk to pregnant women or fetus related to this study protocol.  
9.1 
Therapeutic interventions N/A 
9.2 
Diagnostic interventions N/A 
9.3 
Radiation N/A 
9.4 
Sedation N/A 
9.5 
Risks to family relationships and other psychosocial or economic harms N/A 

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10.0 Description of how privacy and confidentiality of medical 
information/biological specimens will be maximized  
Code words will be used to coordinate assembly of study documents and identifiable 
client information will not be connected with study documents. For initial surveys to be 
matched with post-session surveys for later analysis, clients will choose a code word 
compiled by asking: What is the first street that you lived on? What was your first pet’s 
name? (e.g. OakMondo). This code word will be put on all documents relating to a given 
participant. The client will tell the counselor the code word during the appointment in 
order to label the counselors’ post-visit survey, but no record of the code word in 
association with the client’s name will be created. Cancer is a common condition and we 
do not expect clients to be identifiable through their diagnosis. Code words will be 
destroyed at completion of the study.  
Genetic counselor surveys will not include identifying information for the counselor or 
which after-visit survey was conducted by each counselor. After-visit genetic counselor 
surveys will include the client code-word that will aid in confirming that surveys are 
being completed by counselors.  
10.1 
Description of any clinical/demographic information that will be included.  
For clients, demographic information will be collected including: education, age, sex, 
race, and clinic site. No demographic information will be collected for counselors.  
10.2 
How might this information make specific individuals or families identifiable? 
Since an indication for HBOC genetic counseling is common it is unlikely that 
individuals will be identifiable from this information.  
10.3 
If research data will be coded, how will access to the “key” for the code be 
limited?  Include description of security measures (e.g., password-protected 
database, other).  List names or positions of persons with access to the "key" for 
the code. 
The client will generate the code word based off the prompt “first street you grew up on + 
first pets name.” There will not be a key to link the code word with the clients. The code 
word is designed to be easy for clients to remember. If the study materials do not have 
consistent code words than the AI will attempt to match surveys based on one of the two 
prompted words. If this cannot be accomplished with reasonable certainty that documents 
are from the same client, then the data will not be included in analysis. Counselors will 
know the code word to attach it to the counselor post-visit survey but will not keep a 
record of the code word associated with identifying client information.  
10.4 
N/A 
10.5 
Will personally identifiable information be released to third parties? 
The genetic counselors working with the project will know the code word label to record 
on their after-visit survey but will not keep a record of the code word associated with the 
patient name. No other third parties will have access to identifiable information.  
10.6 
Data sharing.  

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No data will be deposited in any repositories or databases.  De-identified data could 
potentially be shared with other researchers in the future under an IRB approved 
amendment to this protocol or separate IRB-approved research protocol.  Data shared 
would only include de-identified surveys, de-identified intervention, and demographic 
information.    
10.7 
Describe any additional features to protect confidentiality. 
Gift cards will be sent to client participants who fill out the survey in person by having 
clients fill out an address card that is included in the survey information and returned 
separately. Online survey participants will enter gift card information through a separate 
link within the survey site.  
Genetic counselors will be sent gift cards at the conclusion of the study by mail. 
Counselors will provide their addresses to the AI via email.  
10.8 
Loss or destruction of samples.  
Any loss of data, either paper based surveys or breach of electronic data, will be reported 
promptly to the IRB. 
11.0 Assessment of risk/benefit ratio 
Adults: Research does not involve greater than minimal risk and involves the prospect of 
direct benefit to the individual subjects as well as yielding generalizable knowledge about 
improving genetic counseling practice. Efforts to reduce risk include those aimed at 
maintaining confidentiality and obtaining informed consent prior to survey completion. 
Pregnant women: Research does not involve greater than minimal risk and involves the 
prospect of direct benefit to the individual subjects as well as yielding generalizable 
knowledge about improving genetic counseling practice. The research meets the criteria 
contained under 45 CFR 46.204 for research activities involving pregnant women.  
12.0 Unanticipated Problems:  Collection, monitoring, analysis and 
reporting of adverse events and protocol deviations  
 
12.1 
N/A   
12.1.1 N/A 
12.1.2 N/A 
12.2 
Describe plan to monitor and report adverse events and protocol deviations.  
Protocol deviations, unanticipated problems, or non-compliance are defined as described 
in NIH HRPP SOP 16 ("Reporting Requirements for Unanticipated Problems, Adverse 
Events and Protocol Deviations").  All protocol deviations, unanticipated problems, or 
non-compliance occurring during the study, including those observed by or reported to 
the research team, will be recorded.  Serious protocol deviations, unanticipated problems, 
or non-compliance will be reported to the IRB and CD (Clinical Director) as soon as 
possible but not more than 7 days after the PI first learns of the event.  Not serious 

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protocol deviations, unanticipated problems, or non-compliance will be reported to the 
IRB and CD as soon as possible but not more than 14 days after the PI first learns of the 
event.   
No adverse events, serious adverse events, or unanticipated adverse device effects are 
anticipated in this study since there are no medical devices or pharmaceutical 
interventions.  
12.3 
N/A 
13.0 Description of alternatives to participation  
Participation in this study is completely voluntary for both clients and genetic counselors.  
There will be no negative consequences or changes in standard care for not participating 
or for withdrawing from the study.  
14.0 Description of consent process  
 
14.1 
Who will obtain consent (PI, AIs)?  
A written informed consent review will be sent to all potential client participants along 
with the standard clinic information packet. The AI will call all potential participants a 
week prior to their appointment to consent clients, after they have received the 
information packet, and assess clients’ interest in participating in the study.  
Genetic counselors’ consent will be obtained at the beginning of the study through a 
written consent document. Counselors will have an opportunity to ask the AI or PI 
questions regarding the consent through email or phone. Both the counselor and AI or PI 
will sign the informed consent and both parties will receive a copy by email.  
14.2 
Setting where consent will be obtained (location of in-person discussion, phone, 
mail). 
Verbal consent will be obtained from clients by phone. An information leaflet describing 
the consent information will be include in the pre-appointment packet sent to all patients.   
Written consent will be obtained from counselors in the medical office.  
14.3 
What information will be provided to participants? (See attached consent 
appendix B.). 
On the initial phone call with potential client participants, the AI will explain the purpose 
of the study, the risks and benefits, the process of participation, the voluntary nature of 
the study, and withdraw information. The AI will explain that this is a study about using 
an intervention to improve the genetic counseling session.   
The written consent document for counselors will explain the purpose of the study, the 
risks and benefits, the process of participation, the voluntary nature of the study, and 
withdrawal from the study.  

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14.4 
Protections for participants who may be vulnerable to coercion or undue 
influences (pregnant women, fetuses, children, people with impaired decision-
making ability). 
Since this is a feasibility study to assess initial application of SA to a HBOC genetics 
clinic those with intellectual disabilities noted in their medical chart will not be referred 
by genetic counselors for study participation. Pregnant women will be included in the 
study population and we foresee no additional harms caused by study participation. 
Participants must be 18 years of age to participate.  
This research involves no more than minimal risk. 
14.5 
Are there special circumstances regarding obtaining consent?  
We are requesting a waiver of the requirement to obtained signed consent from client 
participants under the grounds of no more than minimal risk 45 CFR 46.110 (c). We 
believe this study meets the criteria for minimal risk and this waiver can be granted 
because “the research presents no more than minimal risk of harm to participants and 
involves no procedures for which written consent is normally required outside of the 
research context.” Counselor participants will complete a signed consent.                                                   
14.6 
If this study involves collaborating sites, indicate if there is a single IRB review or if each 
site’s IRB will review their site’s participation in the study.  Describe plans for ensuring 
appropriate IRB review and approval of consent forms at each site. 
All client and genetic counselor participants will be from St. Luke’s Health System or 
Medstar Washington Hospital Center. The NIH will be the IRB of Record for St. Luke’s 
Health System. The reliance agreement forms have been submitted to the OHSRP. 
Concurrently to this amendment we are seeking exempt review through the Medstar 
Washington Hospital Center IRB.  
15.0 Description of any financial compensation  
 
15.1 
Describe the rationale for and amount of any proposed compensation, consistent 
with SOP 13.  
This protocol includes the intervention, which requires early attendance at the medical 
appointment by the participants, and the post intervention survey. To compensate clients 
for the study participation they will receive a $15 gift card when they complete the study.  
Genetic counselors at St. Luke’s will receive a $1400 gift card for their participation in 
this research. Counselors at Medstar Washington Hospital Center will receive $200 each 
based on lower planned recruitment at this site, shorter time involved in the study, and 
less upfront logistics planning. This will be mailed to the genetic counselor at the 
conclusion of the study. Counselors will be asked to complete a survey after every 
appointment and at the end of the study.  
15.2 
Describe whether compensation will be modified if participant withdraws early. 

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If clients withdraw early or do not complete all surveys they will forfeit their 
compensation. If counselors withdraw before the conclusion of the study they will 
receive $100 per week they counseled clients involved in the study.  
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