Developing and Validating Fertilit-e: An eHealth Fertility Preservation Decision Aid for Young Adults With Cancer - Aim 1
Conditions: Malignant Neoplasm
Sponsor: Wake Forest University Health Sciences

Fertilit-e 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC #  01717 
ClinicalTrials.gov:  NCT03599661
Principal Investigator: 
Co-Investigator(s):  
John M. Salsman, Ph.D. 
Director of Clinical Research in Adolescent and 
Young Adult Oncology 
Wake Forest School of Medicine 
Mollie Canzona, Ph.D. 
Assistant Professor, Department of Communications 
Wake Forest University 
David Miller, M.D. 
Professor, General Internal Medicine Epidemiology 
& Prevention 
Social Sciences & Health Policy 
Wake Forest Baptist Health  
Bansari “Bonnie” Patel, M.D. 
Assistant Professor, Obstetrics and Gynecology 
Reproductive Medicine  
Wake Forest Baptist Health 
Zanetta S. Lamar, M.D. 
Assistant Professor, Hematology & Oncology 
Comprehensive Cancer Center 
Wake Forest Baptis Health 
Biostatistician: 
Janet A. Tooze, Ph.D. 
Professor, Biostatistics 
Wake Forest Baptist Comprehensive Cancer Center  

Fertilit-e 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC #  01717 
Study Coordinator: 
Regulatory Contact: 
Protocol Editor: 
Participating Institution(s): 
Version Date: 
Denisha Little-Greene, MMS 
I
Mac Robinson, PhD 
Wake Forest Baptist Comprehensive Cancer Center 
Wake Forest University School of Medicine Medical 
Center Blvd 
Winston-Salem, NC 27157 
Wake Forest Baptist Comprehensive Cancer Center
06/30/2020 
Amended: 
 
Confidential

Fertilit-e 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 01717 
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Table of Contents 
1.0 
Introduction and Background ............................................................................................ 4 
2.0 
Objectives ......................................................................................................................... 5 
3.0 
Study Population ............................................................................................................... 5 
4.0 
Methods ............................................................................................................................ 6 
5.0      Outcome Measures ........................................................................................................... 7 
6.0 
Analytic Plan ..................................................................................................................... 8 
7.0 
Data Management ............................................................................................................. 9 
8.0 
Confidentiality and Privacy ................................................................................................ 9 
9.0 
Data Safety and Monitoring ............................................................................................. 10 
10.0 
Reporting of Unanticipated Problems, Adverse Events or Deviations ............................ 10 
Appendix A – Subject Eligibility Checklist ................................................................................... 14 
Appendix B – Protocol Registration Form ................................................................................... 14 
Appendix C – Study Measures ................................................................................................... 14 

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Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 01717 
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1.0 
Introduction and Background 
Every year, approximately 70,000 young adults (ages 18-39) are diagnosed with cancer, 
which can significantly affect their health-related quality of life in multiple areas, including 
the potential for infertility or other reproductive challenges. Despite this, very few young 
adults diagnosed with cancer are actually provided fertility preservation information let 
alone effective strategies or tools for how to best navigate their fertility preservation 
options.1 It is critical to provide decision-making information and support about 
infertility risk and existing interventions to maintain reproductive potential in a 
delivery mode that is most congruent with this population’s health communication 
style, such as mHealth applications. Numerous organizations, including the American 
Society for Reproductive Medicine (ASRM),2 American Society of Clinical Oncology 
(ASCO),3,4 and the National Comprehensive Cancer Network (NCCN),5 have established 
national guidelines to enhance provider adherence and facilitate patient and provider 
discussions about fertility preservation options prior to proceeding with fertility 
compromising treatments. These guidelines recommend that 1) all oncologists inform 
their patients about the impact of their cancer and/or treatment on their fertility, and 2) all 
patients who solicit information about fertility preservation receive it, including a referral 
to a reproductive specialist when appropriate. However, previous studies suggest that 
oncologists face many communication challenges when discussing fertility preservation 
with their patients. These challenges can be related to physician attributes (e.g., 
knowledge barriers), patient attributes (e.g., cultural or religious prohibitions for assisted 
reproduction), and healthcare factors (e.g., time demands).6 In fact, a burgeoning 
scientific literature exists on adult oncology providers’ practice patterns and barriers to 
discussing fertility preservation7-16 and suggests that oncologists rarely refer patients 
to fertility preservation specialists6,10 with less than 25% being aware of or 
distributing written educational materials to their patients10  and <50% following 
recommended ASRM/ASCO/NCCN guidelines.6 Similar trends hold true for the dearth 
of fertility preservation information and support provided to young adult cancer patients.17 
When more than one specialist is involved (commonly the case in young adult care), 
information on fertility preservation may be neglected as one specialist may assume 
another already discussed the topic with the patient.  
Given these provider-centered obstacles, it is essential that patients can receive 
timely and accurate fertility preservation information via non-provider channels so 
they can be empowered to ask specific questions and be engaged to make 
appropriate decisions on their own behalf. mHealth interventions represent promising 
options for patient engagement, especially within a younger demographic such as young 
adults with cancer. Technology-enabled communications are increasingly utilized, 
accessible, and can be tailored to reflect specific values and preferences of a population. 
By delivering guideline-based fertility preservation information to young adult 
patients using mHealth technologies, patient knowledge may be increased and 
sustained, and both patients and providers may be more empowered to attend to 
this unaddressed issue through shared decision-making.18 
This study will utilize advances in mHealth technologies to address knowledge deficits, 

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enhance self-efficacy, and promote shared decision-making about fertility options among 
newly diagnosed young adults with cancer and their providers. We will achieve this goal 
by developing an mHealth tool (Fertilit-e) to increase patient knowledge, thereby 
positively impacting self-efficacy for fertility preservation decision-making, and enhancing 
satisfaction with fertility preservation decisions made for this group of underserved 
patients. The use of mHealth interventions has grown significantly in recent years,19,20 
increasing the potential to make decision-making interventions more accessible, 
personally tailored, and integrated into clinical practice. 
2.0 
Objectives 
2.1 
Primary Objective 
2.1.1 Adapt and optimize fertility preservation content in a tailored mHealth 
tool for fertility preservation decision-making. More specifically, we will adapt 
fertility-preservation content for tailored, rapid, and clear dissemination of 
information in an engaging, cross-platform, patient-friendly mHealth format. We 
will alpha-test this tool with an ethnically diverse sample of cross-cultural end users 
to collect qualitative data and evaluate usability to refine content and design. No 
formal hypothesis testing will be done. 
2.2 
Secondary Objective 
2.2.1 To qualitatively evaluate comprehensibility of the mHealth tool. 
2.3 
Exploratory Objectives 
2.3.1 To describe the characteristics of the study population in terms of health 
literacy, sociodemographics, technology use, and eHealth literacy. 
2.3.2 To explore differences in usability by health literacy, sociodemographic 
characteristics, technology use, and eHealth literacy. 
3.0 
Study Population 
Young adult patients are eligible if they: 1) are ages 18 to 39; 2) had a histologically 
confirmed diagnosis of cancer during ages 15 to 39, 3) will be receiving or have received 
treatment associated with a risk of infertility (i.e., systemic chemotherapy, pelvic 
radiotherapy, and/or pelvic surgery with potential impact on reproductive function), 4) 
considered or wish they had considered fertility preservation treatments, 5) are able to 
speak, read, and understand English, and 6) are able to provide electronic informed 
consent 7) have access to the internet 8) have access to a computer that will allow for a 
WebEx research interview. Young adult patients will be excluded if they: 1) had an 
infertility diagnosis prior to cancer diagnosis, 2) had a history of fertility preservation or 
fertility treatments prior to their cancer diagnosis, 3) are more than five years post-cancer-
related treatments (i.e., systemic chemotherapy, pelvic radiotherapy, and/or pelvic 

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surgery). The electronic medical record will be queried to identify potentially eligible 
patients. IRB-approved study flyers may also be disseminated through email blasts 
or postings on websites of local cancer support agencies such as Cancer Services. 
Once potential participants have been identified, a study team member will 
contact patients by phone, email, and/or MyWakeHealth to describe the study, 
answer questions, confirm eligibility, and consent those who are interested. 
Alpha testing will occur with 24 young adults. For this purposive sample, we will 
recruit equal numbers of men and women, one half (n=12) of our sample will be 
from racial or ethnic minority groups, and one fourth (n=6) will have low literacy 
(i.e., <12 years of education). We will recruit participants in three phases that 
correspond to three rounds of computer prototype testing (Round 1, n=6; Round 
2, n=6; Round 3, n=12). We will strive for target representation of racial or ethnic 
minorities and low literacy participants within each phase. 
4.0 
Methods 
4.1 
Registration Procedures 
All patients entered on any WFBCCC trial, whether treatment, companion, 
or cancer control trial, must be linked with a study protocol in EPIC or 
WISER if non Wake patient within 24 hours of Informed Consent. Patients 
must be registered prior to the initiation of the study.   
We will perform the following steps in order to ensure prompt registration 
of our patients: 
1.0 
Complete the Eligibility Checklist (Appendix A) 
2.0 
Complete the Protocol Registration Form (Appendix B) 
3.0 
Alert the Cancer Center registrar by phone, and then send the 
electronic signed Informed Consent Form, Eligibility Checklist and 
Protocol Registration Form to the registrar, either by fax or e-mail. 
Contact Information: 
Protocol Registrar PHONE (336) 713-6767 
Protocol Registrar FAX (336) 713-6772 
Protocol Registrar E-MAIL (registra@wakehealth.edu) 
*Protocol Registration is open from 8:30 AM - 4:00 PM, Monday-
Friday.
4.0 
Fax/e-mail ALL eligibility source documents with registration. 
Patients will not be registered without all required supporting 
documents. 

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Note: If labs were performed at an outside institution, provide a printout of 
the results. Ensure that the most recent lab values are sent. 
To complete the registration process, the Registrar will:  
•
assign a patient study number
•
register the patient on the study
4.2 
Study Procedures 
Led by Dr. Miller (Co-I) and supported by Mr. Hepler (Senior Analyst and 
Programmer), we will configure and enable technological specifications of 
the alpha version of our cross platform, web-based decision-making tool. 
Fertilit-e will leverage the technical infrastructure from Dr. Miller’s validated 
mPath platform (1R01CA178941), and since Fertilit-e will be web-based 
and cross-platform, it will be accessible across multiple different user 
systems and not limited to a tablet or smartphone (e.g., Android, iPhone). 
Further, Informed by the Ottawa Decision Support Framework,21,22 self-
efficacy theory,23-25 and existing fertility preservation decision-aids,26-30 we 
expect Fertilit-e to include, but not be limited to, the following modules: (1) 
personal information, values, and preferences; (2) fertility risks and options; 
(3) personal stories; (4) financial concerns; (5) frequently asked questions;
(6) additional resources; and (7) session summary. Across all modules, the
goal will be to provide tailored information (by gender) about the risks of
infertility and options to preserve fertility if interested.
Alpha Testing with Patients. Aim 1 qualitative activities will be supported 
by the Developing Shared Resource, Q-PRO (Qualitative and Patient-
Reported Outcomes) of the Wake Forest Baptist Comprehensive Cancer 
Center (WFBCCC). Once Fertilit-e alpha content has been developed, we 
will begin pilot testing the material with consented patients (n=6). Patients 
will meet virtually through WebEx or individually in a private setting with a 
member of the research team.. Participants will review a computer 
prototype of Fertilit-e alpha content and its design elements (see 
https://fertilite.phs.wakehealth.edu/). Using an interview guide (Appendix 
C),  a research team member will ask about issues of content, functionality, 
and ease of use (i.e., comprehensibility and usability). Interviews will be 
completed within 45-60 minutes. Alpha testing will be audio and video 
recorded and transcripts will be de-identified prior to subsequent qualitative 
coding by research team member and Dr. Canzona. All participants will 
complete an interviewer administered screener for health literacy31,32 and 
self-report items for technology use, eHealth literacy,33 and need for 
cognition.34 Input will be used to modify Fertilit-e for a second round of 
computer prototype testing (n=6 new patients) which will follow the same 
process as before. 
After two rounds of computer prototype testing have been completed, our 

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team will then review participant input and incorporate pertinent changes 
into a revised version of our decision aid that will be pilot tested with an 
additional 12 new patients who will use Fertilit-e on an iPad. As with earlier 
rounds of computer prototype testing, all participants will meet individually 
with a research team member in a private location.  We will use the “Think 
Aloud” protocol to examine how individuals interact with and interpret 
Fertilit-e. A research team member will also ask each participant additional 
questions about the clarity of content and ease of use following an interview 
guide. At the end of alpha testing, participants will receive $25. Feedback 
will be examined systematically by the study team and Advisory Board after 
each round of computer prototype testing to make necessary modifications 
prior to pilot testing in a subsequent aim.  
5.0 
Outcome Measures 
5.1 
Primary and Secondary Outcomes 
To evaluate Fertilit-e alpha, we will examine its comprehensibility and design 
through a series of think aloud interviews35 and usability with additional open-
ended questions (See Appendix C). We will complement the qualitative data by 
administering the System Usability Scale.36,37 After our alpha testing, we will have 
an eHealth decision aid on fertility preservation (Fertilit-e) ready to be field tested 
in a sample of newly diagnosed young adults with cancer.  
6.0 
Analytic Plan 
6.1 
Analysis of Primary Outcome 
Q-PRO staff will review qualitative data to provide an integrative summary and
identification of key points, potential themes, and areas of further exploration. A
summary report will be created using the interview recordings and  interviewer
field notes. The report would include a summary for each module based on the
data from the Think Aloud and Interview Guide that incorporates usability for
Fertilit-e alpha. Q-PRO will also include a section on general comments and
overall recommendations. Finally, they will be maintaining a spreadsheet that
includes data for the sequence of modules selected, modules skipped, and
overall time spent using the app. Q-PRO will then move to standard analysis
(transcription, thematic analysis, saturation, etc.) for beta testing. 38,39
Our study team will calculate descriptive statistics for the System Usability Scale 
by gender and race/ethnicity. 
6.2 
Analysis of Secondary Outcome 
Q-PRO staff will review qualitative data that incorporates and summarizes
comprehensibility for Fertilit-e alpha using the same techniques and approaches
as described above (Section 6.1).

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6.3 
Analysis of Exploratory Outcomes 
We will calculate descriptive statistics (means and standard deviations, 
frequencies) for all sociodemographic variables, the health literacy scale,31,32 the 
technology use items, the eHealth literacy scale,33 and the Need for Cognition – 
short form34 to describe the study population.  This will be considered exploratory 
due to the small sample size and intentional selection of participant groups. 
To explore differences in usability by health literacy, sociodemographic 
characteristics, technology use and eHealth literacy, we will use t-tests, 
ANOVAs, and correlations to examine the relationship between these variables 
and the outcome of the System Usabilty Scale score. 
6.4 
Sample Size and Power 
The combined sample size from each round of computer prototype testing (N=24) 
should permit us to achieve data saturation for gender (12 men and 12 women) 
With 24 participants, we will also be able to estimate the usability data within ±0.4 
SD for the System Usability Scale using 2-sided 95% confidence intervals (CIs). 
6.5 
Accrual Rate 
The WFBCCC sees a high volume of young adults with cancer annually. In the 
last fiscal year, 901 young adults with cancer were seen and ~550 of those were 
post-treatment survivors. For this purposive sampling strategy, we anticipate 
recruiting 24 young adults within 4 months (or 6 young adults/month). Given the 
relatively large sample sizes of young adults at WFBCCC, we believe our 
proposed sample sizes and timeline are realistic goals.  
6.6 
Length of Study 
Patients will complete their participation in 45-60 minutes. We expect the entire 
qualitative data collection will be completed within 4 months.  
7.0 
Data Management 
Informed consent document 
EPIC/REDCap 
Protocol registration form 
WISER/OnCore 
Study questionnaire 
REDCap 
8.0 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study 
outcomes, minimizing to the fullest extent possible the collection of any information that 
could directly identify subjects, and maintaining all study information in a secure 
manner. To help ensure subject privacy and confidentiality, only a unique study 
identifier will appear on the data collection form. Any collected patient identifying 
information corresponding to the unique study identifier will be maintained on a linkage 

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file, store separately from the data. The linkage file will be kept secure, with access 
limited to designated study personnel. Following data collection, subject identifying 
information will be destroyed, consistent with data validation and study design, 
producing an anonymous analytical data set. Data access will be limited to study staff. 
Data and records will be kept locked and secured, with any computer data password 
protected. No reference to any individual participant will appear in reports, 
presentations, or publications that may arise from the study. 
9.0 
Data Safety and Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and 
safety of study participants. The principal investigator will be assisted by other members 
of the study staff. 
The risks of this study are low; however, staff will be trained to handle situations with 
sensitivity and empathy.  The study coordinator will be trained to monitor for significant 
patient distress or depressive symptoms and will be instructed on the appropriate 
courses of referral is a patient is considered to be at risk for a safety concern.   
10.0 Reporting of Unanticipated Problems, Adverse Events or 
Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or 
protocol changes will be promptly reported by the principal investigator or designated 
member of the research team to the IRB and sponsor or appropriate government 
agency if appropriate. 
In the rare event that a participant becomes distressed as a result of participating in this 
study or rather becomes more reflective and wants to talk about these issues in more 
depth, we will provide referrals to members of the psychosocial support team and/or 
other clinical staff as appropriate. 

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References 
1.
Clayman ML, Harper MM, Quinn GP, Reinecke J, Shah S. Oncofertility
Resources at NCI-Designated Comprehensive Cancer Centers. J Natl Compr
Canc Netw. 2013;11(12):1504-1509.
2.
Ethics Committee of the American Society for Reproductive Medicine. Fertility
preservation and reproduction in cancer patients. Fertil Steril. 2005;83(6):1622-
1628.
3.
Lee SJ, Schover LR, Partridge AH, et al. American Society of Clinical Oncology
recommendations on fertility preservation in cancer patients. J Clin Oncol.
2006;24(18):2917-2931.
4.
Loren AW, Mangu PB, Beck LN, et al. Fertility Preservation for Patients With
Cancer: American Society of Clinical Oncology Clinical Practice Guideline
Update. J Clin Oncol. 2013;31(19):2500-2510.
5.
Coccia PF, Altman J, Bhatia S, et al. Adolescent and young adult oncology
clinical practice guidelines in oncology. J Natl Compr Canc Netw.
2012;10(9):1112-1150.
6.
Knapp CA, Quinn GP. Healthcare provider perspectives on fertility preservation
for cancer patients. Cancer Treat Res. 2010;156:391-401.
7.
King L, Quinn GP, Vadaparampil ST, et al. Oncology nurses' perceptions of
barriers to discussion of fertility preservation with patients with cancer. Clin J
Oncol Nurs. 2008;12(3):467-476.
8.
Quinn G, Vadaparampil S, Gwede C, et al. Discussion of fertility preservation
with newly diagnosed patients: oncologists' views. J Cancer Surviv.
2007;1(2):146-155.
9.
Quinn GP, Murphy D, Knapp C, et al. Who Decides? Decision Making and
Fertility Preservation in Teens With Cancer: A Review of the Literature. J Adolesc
Health. 2011;49(4):337-346.
10.
Quinn GP, Vadaparampil ST. Fertility Preservation and Adolescent/Young Adult
Cancer Patients: Physician Communication Challenges. J Adolesc Health.
2009;44(4):394-400.
11.
Quinn GP, Vadaparampil ST, Gwede CK, Bell-Ellison BA, Albrecht TL. Patient-
physician communication barriers regarding fertility preservation among newly
diagnosed cancer patients. Soc Sci Med. 2008;66(3):784-789.
12.
Quinn GP, Vadaparampil ST, Gwede CK, Mason TM, Reinecke JD, Silva C.
Developing a referral system for fertility preservation among patients with newly
diagnosed cancer. J Natl Compr Canc Netw. 2011;9(11):1219-1225.
13.
Quinn GP, Vadaparampil ST, King L, et al. Impact of physicians' personal
discomfort and patient prognosis on discussion of fertility preservation with young
cancer patients. Patient Educ Couns. 2009;77(3):338-343.
14.
Quinn GP, Vadaparampil ST, Lee JH, et al. Physician referral for fertility
preservation in oncology patients: A national study of practice behaviors. J Clin
Oncol. 2009;27(35):5952-5957.

Fertilit-e 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 01717 
Page 12 of 32 
15.
Clayton H, Quinn GP, Lee JH, et al. Trends in clinical practice and nurses'
attitudes about fertility preservation for pediatric patients with cancer. Oncol Nurs
Forum. 2008;35(2):249-255.
16.
Schover LR, Brey K, Lichtin A, Lipshultz LI, Jeha S. Oncologists' attitudes and
practices regarding banking sperm before cancer treatment. J Clin Oncol.
2002;20(7):1890-1897.
17.
Clayman M, Arntson P, Galvin K. Shared decision making: Fertility and pediatric
cancers. In: Woodruff TK, Snyder KA, eds. Oncofertility fertility preservation for
cancer survivors. New York: Springer Verlag; 2007:149-160.
18.
Knapp CA, Quinn GP. Healthcare provider perspectives on fertility preservation
for cancer patients. In: Woodruff TK, ed. Oncofertility: ethical, legal, social, and
medical perspectives. New York: Springer; 2010:391-401.
19.
Demiris G, Afrin LB, Speedie S, et al. Patient-centered applications: use of
information technology to promote disease management and wellness. A white
paper by the AMIA knowledge in motion working group. J Am Med InformAssoc.
2008;15(1):8-13.
20.
Glasgow RE, Davis CL, Funnell MM, Beck A. Implementing practical
interventions to support chronic illness self-management. JtComm J Qual Saf.
2003;29(11):563-574.
21.
O'Connor AM, Drake ER, Fiset V, Graham ID, Laupacis A, Tugwell P. The
Ottawa patient decision aids. Eff Clin Pract. 1999;2(4):163-170.
22.
O'Connor AM, Jacobsen MJ, Stacey D. An evidence-based approach to
managing women's decisional conflict. J Obstet Gynecol Neonatal Nurs.
2002;31(5):570-581.
23.
Bandura A. Self-efficacy: Toward a unifying theory of behavioral change. Psychol
Rev. 1977;84(2):191-215.
24.
Bandura A. Self-efficacy mechanism in human agency. Am Psychol.
1982;37(2):122-147.
25.
Bandura A. Self-efficacy: the exercise of control. New York: W.H. Freeman;
1997.
26.
Block R, Nail L, Frohnmayer A, et al. The Fertility Preservation Explorer: A
Decision Tool for Adolescent and Young Adult Women with Cancer. Paper
presented at: Oncofertility Consortium 2013; Chicago, IL.
27.
Block R, Nail L, Frohnmayer A, Hayes-Lattin B. The fertility preservation
decision-making process of adolescent and young adult women with cancer.
Paper presented at: International Society of Pediatric Oncology (SIOP) October
28-30, 2011; Auckland, New Zealand.
28.
Northwestern University. myoncofertility.org. 2011;
http://www.myoncofertility.org/. Accessed February 1, 2014.
29.
Northwestern University. Patient Navigator for Fertility Preservation. 2011;
http://fertilitypreservation.northwestern.edu/. Accessed February 1, 2014.
30.
Northwestern University. iSaveFertility iOS Application. 2011;
https://itunes.apple.com/us/app/isavefertility/id436397171?mt=8&ls=1.
31.
Chew LD, Griffin JM, Partin MR, et al. Validation of screening questions for
limited health literacy in a large VA outpatient population. J Gen Intern Med.
2008;23(5):561-566.

Fertilit-e 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 01717 
Page 13 of 32 
32.
Wallston KA, Cawthon C, McNaughton CD, Rothman RL, Osborn CY, Kripalani
S. Psychometric properties of the brief health literacy screen in clinical practice. J
Gen Intern Med. 2014;29(1):119-126.
33.
Norman CD, Skinner HA. eHEALS: The eHealth Literacy Scale. J Med Internet
Res. 2006;8(4):e27.
34.
Cacioppo JT, Petty RE, Kao CF. The efficient assessment of need for cognition.
J Pers Assess. 1984;48(3):306-307.
35.
Kelly-Blake K, Clark S, Dontje K, et al. Refining a brief decision aid in stable
CAD: cognitive audios. BMC Med Inform Decis Mak. 2014;14(1):10.
36.
Brooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry.
1996;189(194):4-7.
37.
Bangor A, Kortum PT, Miller JT. An Empirical Evaluation of the System Usability
Scale. Int J Hum Comput Interact. 2008;24(6):574-594.
38.
Bowen GA. Naturalistic inquiry and the saturation concept: a research note. Qual
Res. 2008;8(1):137-152.
39.
Guest G, Bunce A, Johnson L. How Many Interviews Are Enough? An
Experiment with Data Saturation and Variability. Field Meth. 2006;18(1):59-82.

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Appendix A – Subject Eligibility Checklist 
IRB Protocol No. 
 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 
WFBCCC Protocol No 
.___ ___ ___ ___ ___ 
Study Title: Fertilit-e 
Principal Investigator:  John M. Salsman, Ph.D. 
Inclusion Criteria 
(as outlined in study protocol) 
Criteria 
is met 
Criteria 
is NOT 
met 
Source Used to Confirm * 
(Please document dates and lab 
results) 
Age 18 to 39. 
□ 
□ 
Histologically confirmed diagnosis of 
cancer during ages 15 to 39 
□ 
□ 
Will be receiving or have received 
treatment associated with a risk of 
infertility (i.e., chemotherapy, pelvic 
radiotherapy, and/or pelvic surgery with 
potential impact on reproductive 
function).  
□ 
□ 
 Considered or wish they had considered 
fertility preservation treatments. 
□ 
□ 
Able to speak, read, and understand 
English. 
□ 
□ 
Able to provide informed consent. 
□ 
□ 
Have internet access 
□ 
□ 
Have a laptop, or desktop computer that 
can connect to WebEx 
□ 
□ 
Exclusion Criteria 
(as outlined in study protocol) 
Criteria 
NOT 
present 
Criteria 
is 
present 
Source Used to Confirm * 
(Please document dates and lab 
results) 
Infertility diagnosis prior to cancer 
diagnosis.  
□ 
□ 
History of fertility preservation or fertility 
treatments prior to their cancer diagnosis. □ 
□ 
Are more than five years post-cancer-
related treatments (i.e., systemic 
chemotherapy, pelvic radiotherapy, 
and/or pelvic surgery) 
□ 
□ 
This subject is      
 eligible /  ineligible     for participation in this study. 
OnCore Assigned PID: ___ ___ ___ ___ ___ ___ ___ ___  
Signature of research professional confirming eligibility:_______________________ 
Date: ___ ___/___ ___/___ ___ 

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Signature of Treating Physician**:  _____________________________________  
Date: ___ ___/___ ___/___ ___* Examples of source documents include clinic note, pathology report, 
laboratory results, etc. When listing the source, specifically state which document in the medical record 
was used to assess eligibility. Also include the date on the document. Example: “Pathology report, 
01/01/14” or “Clinic note, 01/01/14” 
**Principal Investigator signature can be obtained following registration if needed 
 
Appendix B– Reduced Review** Registration Form  
DEMOGRAPHICS 
Patient: Last Name: _____________________ First Name: ___________________________ 
MRN:          ___ ___ ___ ___ ___ ___ ___ ___ ZIPCODE: ___ ___ ___ ___ ___ 
*SEX:   
  Male      Female 
 
 
*Ethnicity (choose one):   
 Hispanic        Non-Hispanic 
*Race (choose all that apply): 
 WHITE        African American            
 ASIAN          PACIFIC ISLANDER                 
 NATIVE AMERICAN (Alaskan) 
*Diagnosis: ____________________________________________________________ 
DOB (mm/dd/yy): ___ ___ / ___ ___ / ___ ___ (include if no MRN is provided) 
The Comprehensive Cancer Center requires that all registrations be sent to the CCCWFU Centralized 
Registrar the day the patient is consented; if this is not possible we require that all registration be 
communicated to the Centralized Registrar within 72 hours by the CRM registrar. 
 
**Reduced Review means eligibility and other review are not performed by CRM registrar. 
 
For questions, the Protocol Registrar can be contact by calling 336-713-6767 between 8:30 AM and 4:00 PM, 
Monday – Friday. 
 
Completed Eligibility Checklist and Protocol Registration Form must be hand delivered, faxed or e-mailed to 
the registrar at 336-713-6772 or registra@wakehealth.edu. 
 
 
 
*MD Name (Last, First) : 
______________________, _________________________      
*Date Consent Signed: 
___ ___ / ___ ___ / ___ ___ 
Date of Registration: (if different than 
consent signing) 
___ ___ / ___ ___ / ___ ___ 
PID # (OnCore): 
___ ___ ___ ___ ___ ___ ___ ___ (to be completed by registrar) 
 

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Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 01717 
Protocol version date 04/13/2020  
 
 
Page 16 of 32 
*** if not using the full wakehealth.edu outlook client (full outlook, not web outlook) save this 
file and attach to an email to registra@wakehealth.edu. 
Submitter of this form is responsible for insuring that all regulatory and eligibility requirements 
are met for this registration 

Fertilit-e 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 01717 
Protocol version date 04/13/2020  
 
 
Page 17 of 32 
APPENDIX C. Data Collection Measures 
Variable/Construct 
Measure 
Items Source 
Health Literacy 
Brief Health Literacy Screener 
3 
Chew et al., 2008; 
Wallston et al., 2014 
Patient 
Characteristics 
Sociodemographic variables 
23 
Standard items 
Technology Use 
Type, frequency, and purpose 
of technology use variables 
11 
Study team developed 
eHealth Literacy 
Questions about comfort with 
and use of eHealth information 
10 
Norman & Skinner, 
2006 
Need for Cognition 
Need for Cognition Scale 
18 
Cacioppo et al., 1984 
Comprehensibility 
Interview Guide 
10 
Study team developed 
and informed by Kelly-
Blake et al., 2014 
Usability 
Interview Guide;  
System Usability Scale 
11; 
12 
study team developed; 
Brooke, 1996 
 
 
 

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BRIEF HEALTH LITERACY SCREENER 
1. How often do you have someone (like a family member, friend, hospital/clinic worker or 
caregiver) help you read hospital materials? (Help Read) 
 all of the time 
 most of the time 
 some of the time 
 a little of the time 
 none of the time 
 Refused [DO NOT READ] 
 
 
2. How often do you have problems learning about your medical condition because of 
difficulty understanding written information? (Problems Learning), 
 all of the time 
 most of the time 
 some of the time 
 a little of the time 
 none of the time 
 Refused [DO NOT READ] 
 
 
3. How confident are you filling out medical forms by yourself? (Confident with Forms) 
 extremely 
 quite a bit 
 somewhat 
 a little bit 
 not at all 
 Refused [DO NOT READ] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Chew LD, Griffin JM, Partin MR, et al. Validation of screening questions for limited health 
literacy in a large VA outpatient population. J Gen Intern Med. 2008;23(5):561-566. 

Fertilit-e 
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Page 19 of 32 
 
Wallston KA, Cawthon C, McNaughton CD, Rothman RL, Osborn CY, Kripalani S. 
Psychometric properties of the brief health literacy screen in clinical practice. J Gen Intern Med. 
2014;29(1):119-126. 

Fertilit-e 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 01717 
Protocol version date 04/13/2020  
 
 
Page 20 of 32 
Patient Sociodemographic Variables 
This set of questions is about your cancer treatment and general background. Unless otherwise 
stated, please select only one response for each question. All of the information you provide is 
confidential. 
 
What is your current cancer treatment plan? Check all that apply 
 I have not had any treatment 
 I am currently receiving chemotherapy 
 I am currently receiving radiation 
 I have had surgery to remove or treat cancer or tumor 
 I have completed treatment 
 Other (please describe:____________________________________) 
What is your gender? 
 Male  
 Female  
 Transgender 
 
Are you of Hispanic, Latino, or Spanish origin or descent?  
 Yes, Hispanic, Latino, or Spanish  
 No, not Hispanic, Latino, or Spanish  
 
What is your race? (check all that apply) 
 White 
 Black or African American  
 Asian   
 Native Hawaiian or Other Pacific Islander  
 American Indian or Alaska Native  
 Other  
 
What is your residential zip code?___________________________ 
 
What is your present religion, if any?  
 Protestant; if yes, which denomination? ____________ 
 Roman Catholic 
 Mormon 
 Orthodox such as Greek or Russian Orthodox 
 Jewish 
 Muslim 
 Buddhist 
 Hindu 
 Atheist 
 Agnostic 
 Other _________ 
 No particular religion 
 

Fertilit-e 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
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Protocol version date 04/13/2020  
 
 
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How important are your religious or spiritual beliefs to you? 
 Not at all 
 A little bit 
 Somewhat 
 Quite a bit 
 Very much 
What is the highest grade or level of school that you have completed?  
 8th grade or less 
 Some high school, but did not graduate 
 High school graduate or GED  
 Some college or 2-year degree  
 4-year college graduate 
 More than 4-year college degree  
 
What was your employment or school status JUST BEFORE your cancer diagnosis? 
(check all that apply): 
 Employed full-time (including self-employed) 
 Employed part-time (including self-employed) 
 Full-time homemaker 
 Full-time student 
 On temporary medical leave/disability 
 Unemployed 
 Permanently unable to work 
 
What is your employment or school status NOW? (check all that apply): 
 Employed full-time (including self-employed) 
 Employed part-time (including self-employed) 
 Full-time homemaker 
 Full-time student 
 On temporary medical leave/disability 
 Unemployed 
 Permanently unable to work 
 
What is your current marital / relationship status? 
 
 
 
 
 Single / Never married 
 
 
       
    
 Single/Divorced 
 Single/Widowed 
 Married or living with partner in committed relationship 
 Married but currently separated 
Who lives at home with you? (check all that apply): 
 Parent(s) 
 Grandparents  
 Siblings 
 Spouse 

Fertilit-e 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
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 Significant other/partner 
 Child(ren) Number of children_____ 
 Friend(s)/Roommate(s) 
 I live alone 
 Other, please specify _____________________________ 
 
Who is the primary income earner in your household? 
 Me 
 My spouse or significant other 
 My child 
 My parent(s)* [If patient selects this option, please skip to “In general, would you say 
your health is…” item.] 
 Someone else not listed here, please specify _______ 
 There is no income earner in my household 
 
How many financial dependents (i.e children or other family members) are in your 
household?  
 None 
 1 
 2 
 3 
 4 
 5 or more  
 Do not know 
Using the categories below, please indicate the annual income of your household. Include 
yourself and anyone you live and share finances with.  
 Less than $15,000 
 $15,000 to $29,999 
 $30,000 to $59,999 
 $60,000 to $100,000 
 More than $100,000 
 Do not know 
Are you currently receiving disability payments? 
 No 
 No, but I have applied for disability 
 Yes, short term disability (i.e., pays you a portion of your income for a short period of 
time after you run out of sick leave; depending on your plan, it will generally pay you for 
between 9 and 52 weeks) 
 Yes, long term disability (i.e., pays you a portion of your income after you run out of 
both sick leave and short term disability, Social Security Disability Insurance or 
Supplemental Security Income) 
 Yes, I am permanently disabled 
What is your current primary health insurance provider (mark one) 

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 Medicare 
 Qualified health plan from the Health Insurance Marketplace  
 Medicaid 
 Private insurance (employer-provided) 
 Private insurance (purchased directly) 
 Veterans/Military Insurance 
 I don’t have any health insurance 
Do you have household/family savings that can help pay medical bills? 
 No 
 Yes 
 Don’t know/ Not sure 
In general, would you say your health is…  
 Excellent 
 Very good 
 Good 
 Fair 
 Poor 
How many biological children do you have? _____  
 
How do you feel about preserving your fertility right now? 
 Fertility preservation is not for me. I’m here to learn about my options just in case. 
 I don’t think fertility preservation is right for me. I don’t know if there is a good option. 
 I’m not sure about what to do. I want to explore my options. 
 I’m interested in fertility preservation. I want to compare my options. 
 I want to preserve my fertility. I am ready to select a method.  
 
Rate your awareness of treatments to protect your ability to become a parent 
 Very much 
 Quite a bit 
 Somewhat 
 A little bit 
 Not at all 
 
Rate your comfort level with treatments to protect your ability to become a parent 
 Very much 
 Quite a bit 
 Somewhat 
 A little bit 
 Not at all 
 
Do you, yourself, want to have a (another) baby at some time?” 
 Yes 
 Probably yes 
 Unsure 

Fertilit-e 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
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Protocol version date 04/13/2020  
 
 
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 Probably no 
 No  
 

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The next set of questions will ask you about your use of technology. 
 
Do you have a cellphone? 
 Yes – a cellphone 
 Yes – a smartphone 
 No 
 
(if yes):  How often do you use your phone to send or receive text messages? 
 Every day or almost every day 
 3 to 5 days a week  
 1 to 2 days a week  
 Once or twice a month 
 Less than once a month  
 Never 
 
Have you used a computer or laptop in the last 30 days? 
 Yes 
 No 
 
Do you have a computer or laptop that you could use in your home? 
 Yes 
 No 
 
Do you use the internet? 
 Yes 
 No 
 
(if yes): How often do you access the internet? 
On a smartphone 
 Every day or almost every day 
 3 to 5 days a week  
 1 to 2 days a week  
 Once or twice a month 
 Less than once a month  
 Never 
 
On a tablet device (like an iPad, Amazon Fire, or Galaxy Tablet)  
 Every day or almost every day 
 3 to 5 days a week  
 1 to 2 days a week  
 Once or twice a month 
 Less than once a month  
 Never 
 
On a laptop or computer 
 Every day or almost every day 

Fertilit-e 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
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Page 26 of 32 
 3 to 5 days a week  
 1 to 2 days a week  
 Once or twice a month 
 Less than once a month  
 Never 
 
Which of the following sources did you use to get information about cancer-related 
infertility and treatment options to preserve fertility?  (choose all that apply) 
 
 Physicians 
 Nurses 
 Family and friends 
 Books/magazines 
 National Cancer Institute Cancer Information 800 number 
 Other Cancer organization 
 Internet 
 
Which of the following statements best describes your preferred approach to making 
medical decisions:  (please choose only one answer) 
 
   I prefer to make the final decision about which treatment I will receive. 
   I prefer to make the final decision about my treatment after seriously considering my 
doctor’s opinion 
   I prefer that my doctor and I share responsibility for deciding which treatment is best for 
me. 
   I prefer that my doctor makes the final decision about which treatment will be used, but 
seriously considers my opinion. 
   I prefer to leave all decisions regarding treatment to my doctor.  
 
Which of the following best describes the role you played when the decision was made 
about treatment for your cancer-related infertility?  (please choose only one answer) 
 
  I made the final decision about which treatment I received. 
  I made the final decision about my treatment after seriously considering my doctor’s 
opinion 
  My doctor and I shared responsibility for deciding which treatment was best for me. 
  My doctor made the final decision about which treatment would be used, but seriously 
considered my opinion. 
  My doctor made all treatment decisions 
 
 
 

F ertilit - e 
W a k e F or e st B a pti st C o m pr e h e n si v e C a n c er C e nt er  (W F B C C C ) 
W F B C C C  # 0 1 7 1 7  
Pr ot o c ol v er si o n d at e 0 4/ 1 3/ 2 0 2 0    
  
 
P a g e 2 7  of 3 2  
e He alt h Liter ac y Sc ale  
 
T he f oll o wi n g q uesti o ns are a b o ut y o ur o pi ni o n a n d e x perie nces usi n g t he i nter net f or 
he alt h i nf or m ati o n. F or e ac h st ate me nt, tell me w hic h res p o nse best reflects y o ur o pi ni o n 
a n d e x perie nce ri g ht n o w.    
  
  
 
 
1. H o w usef ul d o y o u feel t he I nter net is i n hel pi n g y o u i n ma ki n g decisi o ns a b o ut y o ur healt h? 
  
 
1 
2 
3 
4 
5 
N ot usef ul 
at all 
N ot usef ul 
U ns ure 
Usef ul  
Ver y Usef ul  
 
2. H o w i m p ort a nt is it f or y o u t o be a ble t o access healt h res o urces o n t he I nter net? 
  
 
1 
2 
3 
4 
5 
N ot 
i m p orta nt 
at all 
N ot 
i m p orta nt 
U ns ure 
I m p orta nt 
Ver y 
i m p orta nt 
 
3. I k n o w w h at  healt h res o urces are a vaila ble o n t he I nter net . 
 
1)  Str o n gl y Disa gree 
2)  Disa gree     
  
 
3)  U n deci de d  
4)  A gree  
5)  Str o n gl y A gree 
 
4. I k n o w w here  t o fi n d hel pf ul healt h res o urces o n t he I nter net. 
 
1)  Str o n gl y Disa gree 
2)  Disa gree     
  
 
3)  U n deci de d  
4)  A gree  
5)  Str o n gl y A gree 
 
5. I k n o w h o w  t o fi n d hel pf ul healt h res o urces o n t he I nter net. 
 
1)  Str o n gl y Disa gree 
2)  Disa gree     
  
 
3)  U n deci de d  
4)  A gree  

F ertilit - e 
W a k e F or e st B a pti st C o m pr e h e n si v e C a n c er C e nt er  (W F B C C C ) 
W F B C C C  # 0 1 7 1 7  
Pr ot o c ol v er si o n d at e 0 4/ 1 3/ 2 0 2 0    
  
 
P a g e 2 8  of 3 2  
5)  Str o n gl y A gree 
 
6. I k n o w h o w t o use  t he I nter net t o a ns wer m y q uesti o ns a b o ut healt h. 
 
1)  Str o n gl y Disa gree 
2)  Disa gree     
  
 
3)  U n deci de d  
4)  A gree  
5)  Str o n gl y A gree 
 
7. I k n o w h o w t o use t he he alt h i nf or m ati o n I fi n d o n t he I nter net t o hel p me. 
 
1)  Str o n gl y Disa gree 
2)  Disa gree     
  
 
3)  U n deci de d  
4)  A gree  
5)  Str o n gl y A gree 
 
8. I ha ve t he s kills I nee d t o e v al u ate t he healt h res o urces I fi n d o n t he I nter net. 
 
1)  Str o n gl y Disa gree 
2)  Disa gree     
  
 
3)  U n deci de d  
4)  A gree  
5)  Str o n gl y A gree 
 
9. I ca n tell hi g h q u alit y  healt h res o urces fr o m l o w q u alit y healt h res o urces o n  t he I nter net. 
 
1)  Str o n gl y Disa gree 
2)  Disa gree     
  
 
3)  U n deci de d  
4)  A gree  
5)  Str o n gl y A gree 
 
1 0. I feel c o nfi de nt  i n usi n g i nf or mati o n fr o m t he I nter net t o ma ke healt h decisi o ns. 
 
1)  Str o n gl y Disa gree 
2)  Disa gree     
  
 
3)  U n deci de d  
4)  A gree  
5)  Str o n gl y A gree 

Fertilit-e 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 01717 
Protocol version date 04/13/2020  
 
 
Page 29 of 32 
Need for Cognition Scale (from Cacioppo, Petty, & Kao, 1984) 
For each of the statements below, please indicate whether or not the statement is 
characteristic of you or of what you believe. For example, if the statement is extremely 
uncharacteristic of you or of what you believe about yourself (not at all like you) please 
place a "1" on the line to the left of the statement. If the statement is extremely 
characteristic of you or of what you believe about yourself (very much like you) please 
place a "5" on the line to the left of the statement. You should use the following scale 
as you rate each of the statements below. 
 
1 
2 
3 
4 
5 
extremely 
somewhat 
uncertain 
somewhat 
extremely 
uncharacteristic 
uncharacteristic 
characteristic 
characteris
ti
of me 
of me 
of me 
of me 
 
1.    
 
I would prefer complex to simple problems. 
2.    
 
I like to have the responsibility of handling a situation that requires a lot of 
thinking.
3.    
 
Thinking is not my idea of fun.** 
4.    
 
I would rather do something that requires little thought than something 
that is sure to challenge my thinking abilities.** 
5.    
 
I try to anticipate and avoid situations where there is a likely chance I will 
have to think in depth about something.** 
6.    
 
I find satisfaction in deliberating hard and for long hours. 
7.    
 
I only think as hard as I have to.** 
8.    
 
I prefer to think about small daily projects to long term ones.** 
9.    
 
I like tasks that require little thought once I’ve learned them.** 
10.    
 
The idea of relying on thought to make my way to the top appeals to me. 
11.    
 
I really enjoy a task that involves coming up with new solutions to problems. 
12.    
 
Learning new ways to think doesn’t excite me very much.** 
13.    
 
I prefer my life to be filled with puzzles I must solve. 
14.    
 
The notion of thinking abstractly is appealing to me. 

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Page 30 of 32 
15.    
 
I would prefer a task that is intellectual, difficult, and important to one 
that is somewhat important but does not require much thought. 
16.    
 
I feel relief rather than satisfaction after completing a task that requires a lot of 
mental effort.** 
17.   
 
It’s enough for me that something gets the job done; I don’t care how or why it 
works.** 
18.   
 
I usually end up deliberating about issues even when they do not affect me 
personally. 
 
Note: **=reverse scored item. 
 
 

Fertilit-e 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 01717 
Protocol version date 04/13/2020  
 
 
Page 31 of 32 
 
Please see IRB for Fertilit-e Alpha Testing Interview Guide 8.27.18 
  
System Usability Scale 
 
For the next questions, please read each sentence and rate your level of agreement. 
 
 
Strongly 
disagree 
 
 
 
Strongly 
agree 
1 
I think that I would like to use 
Fertilit-e frequently (when 
thinking about my fertility 
options) 
1 
2 
3 
4 
5 
2 
I found Fertilit-e unnecessarily 
complex 
1 
2 
3 
4 
5 
3 
I thought Fertilit-e was easy to 
use 
1 
2 
3 
4 
5 
4 
I think that I would need the 
support of a technical person 
to be able to use Fertilit-e 
1 
2 
3 
4 
5 
5 
I found the various functions in 
Fertilit-e were well integrated 
1 
2 
3 
4 
5 
6 
I thought there was too much 
inconsistency in Fertilit-e 
1 
2 
3 
4 
5 
7 
I would imagine that most 
people would learn to use 
Fertilit-e very quickly 
1 
2 
3 
4 
5 
8 
I found Fertilit-e very 
cumbersome to use 
1 
2 
3 
4 
5 
9 
I felt very confident using 
Fertilit-e 
1 
2 
3 
4 
5 
10 
I needed to learn a lot of 
things before I could get going 
with Fertilit-e 
1 
2 
3 
4 
5 
11 
Compared to reading a 
brochure, I liked using Fertilit-e 
more. 
1 
2 
3 
4 
5 
12. Overall, would you rate the user-friendliness of Fertilit-e as: 
 Excellent 
 Good 
 OK 
 Poor 
 Awful 

Fertilit-e 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
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Page 32 of 32 
Brooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 
1996;189(194):4-7.