Helping Oncology Patients Explore-Genomics (HOPE-Genomics) Web Tool Randomized Clinical Trial
Phase: NA
Conditions: Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma, Malignant Solid Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma, Prostate Carcinoma
Sponsor: City of Hope Medical Center

 
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CITY OF HOPE NATIONAL MEDICAL CENTER 
1500 E. DUARTE ROAD 
DUARTE, CA  91010 
Clinical Cancer Genetics - Beckman Research Institute 
 
PROTOCOL TITLE: Helping Oncology Patients Explore-Genomics (HOPE-Genomics) Web Tool 
Randomized Clinical Trial 
PROTOCOL SHORT TITLE: HOPE-Genomics Tool Clinical Trial 
CITY OF HOPE PROTOCOL NUMBER: IRB# 20430 
 
 
PROTOCOL DATE: 02/17/2023 
DATE(S)/ OF AMENDMENT(S)/REVISION(S):  
COH Initial Approval:  
 
Protocol dated 01/25/2021  
 
 
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Protocol dated 01/25/2021 (TITLE PAGE) 
 
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PRINCIPAL INVESTIGATOR: 
Stacy W. Gray, M.D., AM. 
 
CO-INVESTIGATORS: 
 
 
COLLABORATING INVESTIGATOR(S): 
Medical Oncology: Ravi Salgia, MD 
 
Lung Disease Team: Dan Raz, MD, Erminia Massarelli, MD, 
Jack West, MD,  Jyoti Malhotra, MD 

 
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Breast Disease Team: Joanne Mortimer, MD, Mina Sedrak, 
MD, Daphne Stewart, MD 
 
GI Disease Team: Vincent Chung, MD, Marwan Fakih, MD,  
 
Ovarian Disease Team: Mihaela Cristea, MD 
 
Prostate Disease Team: Sumanta Pal, MD 
 
COH Pathology: Michelle Afkhami, MD 
 
Precision Medicine: Steve Gruber, MD, PhD, Kevin 
McDonnell, MD, Gregory Idos, MD, Christine Hong 
 
 
Research Informatics: Amarnath Seshadri MS, Fortino 
Martinez, Allen Mao 
 
 
Genetic Counselors: Bita Nehoray, MS, Duveen Sturgeon, 
MSN, Elisabeth King, MSN, Rachelle Manookian, MS, 
Sandra Drieke, MS, Susan Shehayeb, MS, Lauren Gima, MS, 
Elise Sobotka, MS, MPH, Elyssa Zukin, MS, Ilana Solomon, 
MS 
 
 
Discovery Science: Rebecca Ottesen, MS 
 
 
Patrick Boyd, PhD, MA 
 
 
 
NON-PHYSICIAN CONSENTERS: 
 
  
 
 
 
 
 
 
Ran Qiao, BS (non-physician consenter)  
 
 
 
 
 
 
Cassiel Suarez, BA (non-physician consenter) 
Justin Martinez, BS (non-physician consenter) 
 
 
 
 
 
 
 
BIOSTATISTICIANS:   
 
 
Yi Xiao, MSc (Biostatistician) 
Michael Garcia, MS (data scientist) 
 
MAIN STUDY CONTACT: 
 
 
Patrick Boyd, PhD, MA  
 
 
COMMUNITY PRACTICE SITES: 
Antelope Valley, Corona, Glendora, Mission Hills, Newport 
Beach, Palm Desert, Santa Clarita, South Pasadena, Upland, 
West Covina  
 

 
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PROTOCOL SCHEMA DESIGN PHASE:  
PATIENT PARTICIPANTS 
 
 
 
 
 
 

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Table of Contents 
1.0 
OBJECTIVES .................................................................................................................. 6 
2.0 
BACKGROUND AND RATIONALE ................................................................................ 6 
2.1  
Specific Aims ............................................................................................................................ 7 
3.0 
PARTICIPANT NUMBER, RECRUITMENT, COHORT CHARACTERISTICS AND 
EGLIGIBILITY ........................................................................................................................... 7 
3.1.  Participant Number .................................................................................................................. 7 
3.2.  Duration of Study ..................................................................................................................... 8 
3.3.  Recruitment............................................................................................................................... 8 
3.4.  Cohort Characteristics and Eligibility .................................................................................... 9 
3.4.1 Patient Participants ................................................................................................................... 9 
3.4.2 Cohort Characteristics .............................................................................................................. 9 
4.0  
STUDY PROCEDURES ................................................................................................ 10 
4.1.  Informed Consent and Baseline Survey ............................................................................... 10 
4.1.1 Patient Baseline Survey .......................................................................................................... 11 
4.1.2 Patient Follow Up Survey ....................................................................................................... 12 
4.2 HOPE-Genomics Tool Details & Security Features ................................................................. 14 
4.3 Tool Access and Patient Pre-Education Survey ...................................................................... 14 
4.4  
Results Disclosure ................................................................................................................. 16 
4.5 Follow up Surveys ....................................................................................................................... 17 
4.5.1 10-Day Follow-Up Survey ....................................................................................................... 17 
4.5.2 3 Month Follow-Up Survey ..................................................................................................... 17 
4.5.3 9 Month Follow-Up Survey ..................................................................................................... 17 
4.6 Medical Record Abstraction ....................................................................................................... 17 
5.0 DATA AND SAFETY MONITORING AND UNANTICIPATED PROBLEMS .................... 17 
5.1 Definition of Risk Level ............................................................................................................... 17 
5.2 
Unanticipated Problems (UP) Involving Risks to Subjects or Others ............................... 18 
6.0 
 DATA ANALYSIS ......................................................................................................... 18 
6.1 Sample Size and Accrual Rate: .................................................................................................. 19 
6.2 Statistical Analysis Plan: ............................................................................................................ 19 
6.2.1 Primary Outcome .................................................................................................................... 19 
6.2.2 Secondary Outcome ............................................................................................................... 19 
6.2.3 Exploratory Outcomes ............................................................................................................ 20 
7.0 
 MONITORING AND PERSONEL RESPONSIBLE FOR MONITORING ...................... 22 
8.0  
HUMAN SUBJECT ISSUES .......................................................................................... 22 
8.1 Potential Risks to Participation ................................................................................................. 22 
8.2 Potential Benefits to Participation ............................................................................................. 23 
8.3 Potential Benefits to Others ....................................................................................................... 23 
8.4 Alternatives to Participation ....................................................................................................... 23 
8.5 Informed Consent ........................................................................................................................ 23 

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8.6 Registration into Clinical Trails On-Line system ..................................................................... 23 
8.7 Participant Withdrawal from Research ..................................................................................... 23 
8.8 Financial Obligations and Compensation ................................................................................. 23 
8.9 Confidentiality ............................................................................................................................. 24 
9.0 DEVIATIONS ..................................................................................................................... 24 
9.1 
Reporting Deviations ............................................................................................................. 24 
9.2 
Single Subject Exception (SSE) Amendment Request ....................................................... 24 
10.0 REFERENCES .............................................................................................................. 26 
11.0 APPENDICES ............................................................................................................... 28 
Appendix A: 
Physician Patient-Specific Recruitment Letter ..................................................... 28 
Appendix B: Patient Invitation Letter .............................................................................................. 29 
Appendix C: Patient Invitation Phone Script .................................................................................. 31 
Appendix D: Patient Reminder Letter .............................................................................................. 32 
Appendix E: Patient Interest Postcard ............................................................................................ 34 
Appendix F: Patient Verbal Consent Phone Script ........................................................................ 35 
Appendix G: Patient Script to Setup Access to HOPE-Genomics tool – RoR + Intervention Arm
 ............................................................................................................................................................ 39 
Appendix H: Patient Script to Invite Viewing of Tool w/ Results – Either Intervention Arm ...... 40 
Appendix I: Baseline Survey Invitation Letter ................................................................................ 41 
Appendix J: Pre-Test Survey Invitation Letter ............................................................................... 42 
Appendix K: Follow-Up Survey Invitation Letter (10 day/3 month/9 month for Intervention 
Arms) .................................................................................................................................................. 43 
Appendix L: 10-Day Follow-Up Survey Invitation Letter (10 day/3 month/9 month for Usual 
Care Arm) ........................................................................................................................................... 44 
Appendix M: Patient Script Inviting Remote Tool Viewing w/ Test Results ................................ 45 
Appendix N: Patient Incentive Letter ............................................................................................... 47 
Appendix O: Patient Knowledge Answers & Genomic Information Letter .................................. 48 
Appendix P: HOPE-Genomics Survey Script (Via Phone or Zoom) ............................................. 53 
Appendix Q: HOPE-Genomics Withdrawal Email Template .......................................................... 54 
Appendix R: Patient Survey Link Text Message Script (Baseline/Pre-study/10 day/3 month/9 
month for Intervention Arms) ........................................................................................................... 55 
Appendix S: Setup Access to HOPE-Genomics toll – RoR + Intervention Arm Text Message 
Script .................................................................................................................................................. 56 
Appendix T: Patient Reminder to View HOPE-Genomics with Genetic Test Results Text 
Message Script .................................................................................................................................. 57 
Appendix U: Text-Message Opt-in for Previously Consented Subjects - Template for Email and 
Mailer .................................................................................................................................................. 58 
 
 
 

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1.0 
OBJECTIVES 
The introduction of large-scale genomic testing in medicine promises to transform patient care. Cancer 
is at the leading edge of this revolution and hundreds of thousands of cancer patients receive tumor 
genomic testing yearly. Understanding how genomic information is conveyed in the context of cancer 
has broad relevance across the spectrum of human disease. Early evidence reveals that despite rapid 
adoption of genomic testing in cancer, many patients fail to comprehend basic information about cancer 
genetics or the defining genomic characteristics of their disease. For example, many breast cancer 
patients lack knowledge about their own tumor biomarkers and such knowledge deficiencies have been 
associated with lower adherence to highly effective targeted therapies.1 Given that better-informed 
patients can more effectively engage in their care, and that greater knowledge about cancer and one’s 
personal health characteristics is associated with improved cancer-related outcomes, there are 
significant concerns that patients’ genomic knowledge deficits may contribute to poor quality care. In 
this context there is an urgent need to educate patients about cancer genomics generally, and their 
sequencing results specifically, in a format that is usable, useful, and that easily integrates into existing 
clinical workflows.   
The goal of our research program is to improve the delivery of high-quality precision cancer medicine. 
In the current study, we plan to test the efficacy of providing patients with direct access to their 
sequencing results and information on cancer genomics through a web-based interface, Helping 
Oncology Patients Explore-Genomics (HOPE-Genomics).  
2.0 
BACKGROUND AND RATIONALE 
We are in the midst of a genomic revolution; more than 250,000 human 
genomes have been sequenced, generating over a petabase of genomic 
data. If these data were used correctly, they could save hundreds of 
thousands of lives each year. However, there is a disconnect between 
genomic discovery and clinical care. Physicians frequently misinterpret 
genomic information and patients often don’t understand their own test 
results. To address these care gaps, we have developed tools to help 
physicians and patients interpret, use, and share genomic data. Our work 
has been primarily in cancer and we aim to further develop and test tools 
that overcome gaps in genomic care delivery. Our overarching goal is to 
optimize the integration of whole-exome and whole-genome sequencing 
(WES, WGS) into general clinical practice.  
The ineffective implementation of genomic discoveries produces a 
ubiquitous “last mile” problem.1,2 For example, BRCA testing has been guideline-endorsed for 20 years 
but most patients who could benefit from testing are not sequenced. Moreover, data misinterpretation 
and poor communication has devastating consequences, including unnecessary organ removal, missed 
disease prevention opportunities, and premature death. Without rigorous interventions to address these 
problems, the societal investment of billions of dollars in genomics may yield little real world payoff.1  
Figure 1: Traditional & 
emerging communication 
models (panels A & B) 

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Most attempts to improve genomics-based care have targeted only one clinical factor and have focused 
on a few genes. Multi-level interventions, ones that target multiple factors, are hypothesized to be more 
effective.3 Furthermore, tools are needed to communicate WES/WGS data to physicians and patients, 
including non-English speakers. Our work will improve care by transforming genomic communication 
from a traditional model of linear information flow to one that puts patients at the center of communication 
and enables them to seamlessly connect with providers, labs, and family members (Figure 1).  
This proposal builds on our prior research and preliminary data which demonstrates that patients 
frequently don’t know that they have had sequencing or understand the implicaitons of their results, and 
that many physicians don’t understand sequencing information.4-10 In order to overcome these problems, 
we developed a patient intervention called HOPE-Genomics. HOPE-Genomics is an interactive, web-
based, point-of-care tool that 1) educates patients about genomics, 2) enables direct-to-patient return-of-
results, and 3) facilitates sharing of genomic results within families. Based on pilot testing, we have found 
this interveniton to be highly acceptable to patients and clinicians. 
2.1  
Specific Aims 
In the proposed work we aim to:  
 
• 
Aim 1: Test the efficacy of the HOPE-Genomics intervention in improving patient knowledge of 
genomics (recall rates) 
Hypothesis: The use of HOPE-Genomics will result in higher rates of patient knowledge 
(recall rates) of genomics and their personal test results 
Strategy: We will conduct a randomized controlled trial of HOPE-Genomics as an 
educational tool among patients receiving WES/WGS as a part of their clinical care. 
 
• 
Aim 2: Test the efficacy of the HOPE-Genomics intervention in improving patient receipt of 
guideline-concordant care 
Hypothesis: The use of HOPE-Genomics, will result in higher rates of uptake of evidence-
based genetically-guided care vs. usual care. 
Strategy: We will conduct a randomized controlled trial of HOPE-Genomics among 
patients who receive WES/WGS as a part of their clinical care.  
 
3.0 
PARTICIPANT NUMBER, RECRUITMENT, COHORT CHARACTERISTICS AND 
EGLIGIBILITY 
3.1.  
Participant Number 
We anticipate recruitment and enrollment of approximately 465 patients for this study and assume a 
10% overall attrition rate after enrollment. We will recruit from among patients who consent to the COH 
IRB 07047 Precision Medicine protocol and who have been or had been diagnosed with cancer. For 
07047 overall, we estimate approximately 4000 total patients in year 1 of Precision Medicine (beginning 
CY 2021), 6000 total patients in year 2, and larger numbers yet in subsequent years, demonstrating 
likely feasibility. Given that patients who consent to 07047 may receive WES (e.g. GEM ExTra), Panel 

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Testing (e.g. HopeSeq), and/or germline (e.g. Invitae) as part of their care, they will have the genomic 
testing that is necessary for this education intervention study.  
3.2.  
Duration of Study  
Protocol will end when enrollment has reached limit of 465, and all study activities have concluded. 
3.3.  
Recruitment  
We will enroll approximately 465 patients from City of Hope Duarte main campus and community 
locations. Patients will be identified in collaboration with the COH Precision Medicine (PM) team. Dr. 
Gray, the study PI, is the Deputy Director of the Center for Precision Medicine and works closely with 
the entire PM team. Patients who have consented to COH IRB 07047, who are having genomic 
sequencing through 07047, and who have solid tumor diagnoses (see eligibility criteria below) will be 
eligible to participate. Patients will provide consent to this protocol at the start of their participation in the 
study and will subsequently be randomized into either the control arm (i.e., Usual Care), the Return of 
Results arm or the Return of Results plus Pretest Education arm.  
 
In Clinic Recruitment 
Potentially eligible patients will be approached by study team members during clinic visits for verbal 
informed consent. Patients will either be enrolled on site or given a study packet containing an invitation 
letter, informed consent document, return envelope, and a postcard to denote interest in participating or 
declination. Patients who do not return the postcard within 2-3 weeks will be contacted by a study team 
member to reassess interest in participating. Patients will be contacted either by telephone or web-
conference or will be contacted at their next COH appointment in person. For patients interested in 
participating, study staff will schedule a verbal informed consent session by telephone, web-
conference, or a patient’s next COH appointment in person.  
 
Remote Recruitment 
When in-clinic recruitment is not feasible, potentially eligible patients will be contacted by study team 
members via telephone/email to gauge interest and potentially schedule a verbal consent session. If 
the patient cannot be reached, participants will be mailed a study information packet containing an 
invitation letter, informed consent document, return envelope, a postcard to denote interest in 
participating or declination.  Study staff will also email patients to encourage contact. Patients who do 
not return the postcard within approximately 7-10 days weeks will be contacted by a study team 
member to reassess interest in participating, either by telephone or web-conference. Study staff will 
schedule a verbal informed consent session with patients who are interested in participating, either by 
phone or web-conference.    
Waiver of Documentation of Informed Consent  
We have requested a waiver of documentation of informed consent for patient participants in the 
randomized clinical trial. This portion of the study qualifies for waiver of documentation of informed 
consent under the criteria established by the Office of Human Research Subjects Protection that:  
(1) The research involves no more than minimal risk to the subjects; 
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects; 

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(3) The research could not practicably be carried out without the waiver or alteration; and 
(4) Whenever appropriate, the subjects will be provided with additional pertinent information 
after participation. 
 
This randomized clinical trial entails data collection through surveys and data from existing medical 
records, which fall under these criteria.  
 
Although we will be requesting a waiver of documentation of informed consent, study staff will fully 
review the information sheet that contains all elements of informed consent with the participant before 
the participant starts any study activities. During patient recruitment, the study staff will keep additional 
documentation that information sheet was reviewed with the participant, through OnCore and REDCap 
systems.  
3.4.  
Cohort Characteristics and Eligibility 
3.4.1 Patient Participants 
Patients will be eligible if: 1) they are enrolled in COH IRB 07047, 2) have a cancer diagnosis, 3) 
they are having somatic, germline or paired somatic/germline sequencing, 4) they are fluent in 
English, 5) they have an ECOG performance status of 0-2, and 6) they are ≥ 18 years old. 
 
Patients will be ineligible if they 1) are unable to provide informed consent.  
 
3.4.2 Cohort Characteristics 
In accordance with NIH guidelines, women and members of minority groups and their 
subpopulations will be included in this protocol. We will aim for the proportion of minority 
participation in the study to be representative of the patient population seen by our clinics at the 
City of Hope Cancer. The following percentages of racial and ethnic groups constitute the City 
of Hope clinic population: 15% Hispanic, 2% African American, 5% Asian, 0.2% American 
Indian/Alaska Native, 0.2% Native Hawaiian or Other Pacific Islander and 78% are Caucasian.  

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4.0  
STUDY PROCEDURES 
4.1.  
Informed 
Consent and Baseline 
Survey   
Potentially eligible 
patients will be 
approached by study 
team members for verbal 
informed consent, either 
by mail/ email, during 
clinic visits, or by phone. 
Patients will receive a 
study packet that will 
contain an invitation letter, 
interest postcard, return 
envelope, and informed 
consent document. 
Patients will be 
randomized into one of 
three arms immediately 
after enrollment. Arm 1 is 
usual care, Arm 2 is return 
of results only in the 
HOPE-Genomics tool, 
and Arm 3 is return of 
results plus pretest 
education in the HOPE-
Genomics tool. 
 
Arm 1 patients will receive 
a pamphlet (20430 Educational Brochure in iRIS) about WES after they enroll. Their clinician will return 
their genomics test results in a typical manner, without the assistance of the HOPE-Genomics tool. 
 
Arm 2 patients will receive their genomics test results both from their clinician and from the HOPE-
Genomics tool but will only view the tool after their results are available. Arm 3 patients will view the 
HOPE-Genomics tool (containing educational content) before their sequencing results are available. 
These patients will also receive their genomics test results both from their clinician and from the HOPE-
Genomics tool. After completing all study surveys at 9 months post results disclosure, participants in 
Arm 1 (usual care), will receive access to the HOPE-Genomics tool, which will contain both the 
educational information and the personalized genomics results.  
 
 
 
 
Table 1: Outcome and covariate data collection 
 
 
 
Patient surveys 
 
MRA 
 
Baseline  
Pre-edu. 
survey 
T1 
T2 
T3 
 
Genetic Care outcomes 
 
 
 
 
 
 
MD recommendations 
 
 
 
 
 
 
Screening, surgery, meds 
 
 
X 
X 
X 
X 
Referrals GC, specialists 
 
 
X 
X 
X 
X 
Cascade testing 
 
 
X 
X 
X 
X 
Patient utilization/behavior 
 
 
 
 
 
 
Screening, surgery, meds 
 
 
X 
X 
X 
X 
Consult GC, specialists 
 
 
X 
X 
X 
X 
Inform family members 
 
 
X 
X 
X 
 
Cascade testing 
 
 
X 
X 
X 
 
Patient-centered outcomes 
 
 
 
 
 
 
Recall of results  
X 
 
X 
X 
X 
X 
Understanding of results 
 
 
X 
X 
X 
 
Genomic knowledge  
X 
X 
X 
X 
 
 
Engagement in care 
 
 
X 
X 
X 
 
Information seeking 
 
 
 
X 
 
 
Psychosocial impact 
X 
 
X 
X 
X 
 
Follow up outcomes 
 
 
 
 
 
 
HOPE-Genomics usability  
 
 
X 
X 
 
 
Satisfaction with MD-patient 
communication and care 
 
 
X 
X 
 
 
Covariates  
 
 
 
 
 
 
Socio-demographics 
X 
 
 
 
 
X 
Clinical information 
 
 
 
 
 
X 
Other (e.g., health literacy) 
X 
 
 
 
X 
 
 
 
Medical record abstraction (MRA); Post disclosure: 10 days (T1); 3 months (T2); 9 
months (T3); Medications (Meds); Genetic counseling (GC); Physician (MD)  

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4.1.1 Patient Baseline Survey 
At time of consent, patients will complete the baseline survey. Baseline survey outcomes are detailed in 
Table 1. We will follow standard survey methods as outlined by Dillman2,3 (e.g., contact type and 
intervals; mail/email/in-person reminders) to ensure high response rates. The survey will be 
administered in one of the following ways, according to patient preference: (1) mailed to the participant, 
along with a return envelope, (2) provided electronically and/or by text message via REDCap survey 
link, or (3) completed over a scheduled phone or Zoom call with a study staff member. For patients who 
complete the baseline survey via phone or Zoom call, study staff will not assist them in selecting the 
correct answers for questions pertaining to their understanding of cancer and genetics.   
Germline sequencing knowledge will be measured using an adapted version of the UNC Genomics 
Testing Knowledge Scale1, a validated 25-item measure developed by Langer and colleagues to 
evaluate overall understanding of genomics and health. We will also assess patients’ knowledge of the 
implications of WES on 1) personal cancer risk, 2) family cancer risk, and 3) genetics generally.  
General cancer genomics knowledge will be assessed using a modified form of a 12-item measure 
developed by Blanchette and colleagues.5 The measure assesses three domains of cancer genomic 
knowledge: 1) general understanding of cancer, 2) how biological changes influence cancer, and 3) the 
potential implications of genomic testing in cancer.  Higher general cancer genomic knowledge has 
been associated with higher levels of education, higher personal income and patients’ perceived ability 
to provide informed consent for genomic testing.  
Knowledge about the use of genetic testing in cancer will be assessed using a 6-item measure 
developed by Roth, Gray and colleagues for the Lung-MAP study (unpublished). The measure 
assesses participant’s knowledge of why genetic testing is used in cancer care (e.g., to help select a 
treatment, to predict response to treatment). Eight items have been added in the following content 
areas: 1) use for cancer staging, 2) use to time cancer onset, 3) use to predict treatment efficacy, 4) 
use for clinical trials, 5) use to monitor cancer treatment, 6) use to identify a cancer’s location, 7) use to 
determine metastasis, and 8) use to assess cancer risk.  
Knowledge about the difference between somatic and germline testing (categorical questions) will be 
assessed using a 7-item measure developed by Roth, Gray and colleagues for the Lung-MAP study 
(unpublished). The measure  assesses participant’s knowledge about 1) germline mutations found 
every cell of the body and 2) somatic mutations found only in cancer cells.6 4 items have been added in 
the following content areas: 1) finds gene changes that a person was born with, 2) finds gene changes 
that have happened over a lifetime, 3) finds gene changes that are passed from parent to child, and 5) 
commonly has health implications for family members.  
Understanding of personal genomic knowledge will be assessed through an adapted version of a 
measure created by Freedman and colleagues1, which evaluated women’s knowledge of their personal 
cancer ER and HER2 status using a two-item question (3 response options; yes/no/I don’t know). Our 
adapted questions will evaluate patients’ recall of genomic testing results and the implications of their 
results (i.e., harmful and unknown). Patient recall will also be assessed 10 days, 3 months and 9-
months following results disclosure with a clinician.  
 

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Recall of prior genetic counseling will be assessed with a single question (3 response options; yes/no/I 
don’t know) created by Sheppard and colleagues, which evaluated African American women’s 
experiences with counseling counselling for hereditary breast cancer.2 
 
Psychosocial wellbeing/anxiety/depression/stress will be assessed at baseline and at each follow-up 
timepoint using a 14-item measure from Zigmond’s Hospital Anxiety and Depression scale.3 These 
questions will assess potential changes in patients’ psychosocial wellbeing in response to genetic 
testing and their experience with cancer throughout the randomized trial.  
 
Socio-demographics will be assessed using questions (including race, ethnicity, marital status, 
education) from the Centers for Disease Control and Prevention’s Behavioral Risk Factor Surveillance 
System (BRFSS) questionnaires.  The BRFSS questionnaires are health-related telephone surveys that 
collect state data about U.S. residents regarding their health-related risk behaviors, chronic health 
conditions, and use of preventive services.4 Primary language spoken will be assessed by a 4-item 
measure developed for CSERII. Sex, gender, and date of birth will be assessed using measures from 
CSERII. 
 
Other covariate data (e.g., health literacy, numeracy, health status, and primary language spoken) will 
be assessed using validated measures.   
• 
Health literacy will be assessed by up to 3 single-item health literacy screening questions, as 
evaluated by Chew and colleagues.5   
• 
Numeracy will be assessed by a 3-item version of the Subjective Numeracy Scale (SNS-3), as 
validated by McNaughton and colleagues.17   
• 
Health-related Internet use will be assessed by a an adapted 1-item measure from the National 
Cancer Institute Health Information National Trends Survey (HINTS).18,19  
• 
Health status will be assessed by a validated single item measuring general self-rated 
health.18,20,21 
• 
Patient-reported functional status will be measured by a single item measure developed by 
Basch and colleagues (patient ECOG-PS). 22 
• 
Quality of care will be assessed using a single item measure from HINTS.6  
 
4.1.2 Patient Follow Up Survey 
 
The follow up surveys will either be mailed to the participant, along with a return envelope, provided 
electronically and/or by text message via REDCap survey link, or completed via phone or Zoom call 
with a staff member, according to patient preference. For patients who opt to complete their follow-up 
surveys via phone or Zoom call, study staff will not assist them in selecting the correct answers for 
questions pertaining to their understanding of cancer and genetics. Study staff will follow-up with 
patients once a week within 2–3-week window to encourage completion of the survey. We will attempt 
to contact non-responders up to five times to encourage survey participation. 
 

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Understanding of personal genomic knowledge will be assessed through an adapted version of a 
measure created by Freedman and colleagues1, which evaluated women’s knowledge of their personal 
cancer ER and HER2 status using a two-item question (3 response options; yes/no/I don’t know). Our 
adapted questions will evaluate patients’ recall of genomic testing results and the implications of their 
results (i.e., harmful and unknown). Patient recall will be assessed at all survey timepoints (i.e., at 
baseline, 10 days, 3 months and 9-months following results disclosure with a clinician).  
 
Engagement in care will be assessed by a novel item that queries patients as to whether WES 
prompted questions to care providers (yes, no, don’t know). We will use items adapted for our CSERII 
study to ask patients if they recall changes to their cancer treatment as a result of their genomic test 
results. We will also assess engagement via interactive functionality of HOPE-Genomics (see 
below).Seeking and sharing information about genetic tests will be assessed using two items from the 
Health Information National Trends Survey (HINTS) 4 that were adapted for our CSERII study.7  
 
Satisfaction with physician/patient communication around the results of gene testing will be assessed 
with a 7-item measure adapted from HINTS 3 & 4. Satisfaction with care will be assessed using a 
single item measure from Charles and colleagues that was created to evaluate satisfaction with genetic 
counseling and that was adapted for our CSER1 study.14 We have also included two novel questions to 
assess whether patients (1) recalled asking their healthcare providers about their genetic test results 
and (2) recalled receiving a copy of their genetic test report.  
 
Psychosocial impact of genetic testing and patient uncertainty will be assessed using both the adapted 
PAGIS Certainty Scale and the FACToR.23 The FACToR is a 12-item measure developed by CSER1 
colleagues at the University of Washington that applies across disease contexts and also includes 
items related to uncertainty, test-related distress, and positive experiences. Uncertainty about genetic 
testing results will be assessed using the PAGIS. A 5-item measure by Read and colleagues 
(Psychological Adaptation to Genetic Information Scale; PAGIS certainty subscale).8 
 
Tool usability/usefulness/acceptability will be assessed for patients who view the HOPE-Genomics tool 
(Arms 2 and 3) approximately 10 days and 3 months after results disclosure. HOPE-Genomics 
usability/acceptability will be assessed using two instruments. To assess system usability, we will use 
the System Usability Scale (SUS).9 The SUS is a 10-item measure that evaluates a variety of aspects 
of system usability including the perceived complexity of a system and the need for support and training 
to facilitate use. We will also use an adapted version of the Electronic Self-Report Assessment-Cancer 
(ESRA-C).13 The ESRA-C is a 6-item measure that assesses participants’ opinions about a web-
intervention (e.g., easy and enjoyable, acceptability of time required to navigate, overall satisfaction). 
The ESRA-C is written at a 5th-grade reading level and is highly reliable (Cronbach alpha 0.76).  
 
Motivations for sharing genetic test results will be assessed using a modified 9-item measure adapted 
from our CSERII study and the Development of the Informing Relatives Inventory (IRI) by de Gues and 
colleagues.10 Patients will be asked to rank the importance of various reasons for sharing genetic test 
results on a 5-point scale, from “Not At All Important” to “Very Important.” This measure will only be 
included in the 3-month follow-up survey and will be included as an exploratory measure.  

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4.2 HOPE-Genomics Tool Details & Security Features 
The HOPE-Genomics tool is a web-based, interactive tool that provides personalized genomics results 
and educational content to patients. The tool was designed with stakeholder feedback and we have 
collaborated closely with the COH Research Informatics group to build a fully functioning HOPE-
Genomics tool on the HL7 SMART on FHIR platform. For this effort, Research Informatics has built a 
Web-based responsive application that can be accessed through any popular web browser using 
devices with varying screen sizes, like computers, tablets, and mobile phones.  
Securing the application and the patient data is one of the design principles of this platform; application 
enforces two-factor authentication for its users to login, when a user signs up for an account, he/she will 
have to provide a phone number during the registration process. Subsequently the user will have to 
enter a code sent to the phone (number used during registration) along with the password to login to 
the application. The application backend uses a JSON Web Token mechanism to authenticate every 
request coming into the server. A secure token is generated upon user login, and token should be 
attached to every request to the backend API for the request to be successful. Tokens automatically 
expire after 30 mins of non-usage and forces the user to login again. 
The application also offers secure authorization mechanism, application backend authorizes every data 
request to make sure the user requesting the information is authorized to view the information. The 
authentication token when generated is assigned to a patient resource, and data related to that patient 
resource can only be retrieved from the API using the token generated. The application is also hosted 
within City of Hope firewall keeping it secure from various vulnerabilities. The application is made 
available on https to enforce end-to-end secure connection between the patient’s browser and the 
application server. The tool also offers some administrative capabilities, this tool provides direct access 
to all enrolled patients and allows the study team to manage patient’s account details. Each patient 
user is assigned a FHIR ID that cannot be linked or traced back to the patient’s MRN. Lastly, no PHI is 
captured through the HOPE-Genomics platform, as patients are not asked to input any personal 
information into the application, and it is not directly linked to the electronic medical record. Our 
informatics team performs cybersecurity scans every week on the entire HOPE-Genomics application 
to look for any vulnerabilities. They will then assess the severity of any detected vulnerabilities and fix 
them as needed. 
4.3 Tool Access and Patient Pre-Education Survey 
After enrollment, all participants will be provided with a hard-copy or electronic educational pamphlet 
about whole-exome sequencing (WES). Patients in the Return of Results plus Pre-test Education arm 
will be provided with login and dual-factor authentication instructions and have immediate access to 
educational content in the tool, with their sequencing results to become available in the tool shortly after 
their results are available in Epic. Patients in the Return of Results Only arm will not be able to see tool 
content until their genomic test results are available (e.g., ~2-6 weeks after sample collection). Patients 
in the Usual Care arm will have access to the tool content after completing all study surveys, 
approximately ~9 months after their have sequencing results are available.  

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Approximately 2-3 days after completing the baseline survey, patients in all study arms will complete a 
pre-test education survey that assesses general genomic knowledge prior to results disclosure. For 
patients requesting paper versions of the baseline and pre-test surveys, we will mail the pre-test survey 
1 week after mailing the baseline. This will ensure that patients who opt for paper surveys can complete 
the pre-test survey within 2-3 days of completing their baseline survey. As with all study surveys, 
patients will also have the option of completing the pre-test education survey over a scheduled phone 
or Zoom call with a study staff member. During the phone or Zoom call, study staff will not assist 
patients in selecting the correct answers for questions pertaining to their understanding of cancer and 
genetics. As mentioned above, patients in the Return of Results plus Pre-test Education arm (Arm 3) 
will view the HOPE-Genomics tool prior to their results disclosure and completion of this survey. The 
HOPE-Genomics tool will be populated with educational material about genomics, cancer, and other 
related content, but without the patient’s individual test results. We will track Arm 3 patients’ tool access 
through Google Analytics, which is an IT-approved software that monitors user interaction metrics 
within the HOPE-Genomics platform, specifically button clicks per page, page scrolls, double clicks, 
and page-viewing duration times. We are utilizing Google Analytics to better understand which features 
of the tool are most frequently used by patients and identify technical aspects of the tool that need 
improvement. The version of Google Analytic implemented (GA4) in the HOPE-Genomics platform has 
a process of data anonymization, so no IP address or other PHI is collected from the participants. In 
addition, Google Analytics does not gather text data from the HOPE-Genomics platform and therefore 
has no access to potential PHI within the HOPE-Genomics platform. Additional security features of the 
HOPE-Genomics platform are discussed in Section 4.2 of this protocol (HOPE-Genomics Tool Details 
& Security Features). Study staff will call and/or email patients in the Return of Results plus Pre-Test 
Education arm within approximately 24 hours of receiving their login information to track whether 
patients interact with the HOPE-Genomics platform and if patients have not accessed the tool, study 
stuff will encourage and facilitate intervention use. All other patients (Usual Care & Return of Results 
Only) will only view the WES pamphlet before completing this survey. The HOPE-Genomics 
educational content will be available to those patients in the Return of Results Only and Usual Care 
arms but will only be made available after their genomic test results are available in the tool.  
To improve patient compliance to study requirements, all patients will be presented with the option to 
opt-in to receive text message reminders related to study participation and to receive access to unique 
survey links. Patients will have the option to opt in and opt out of receiving text message reminders at 
any point during their participation; the decision would not affect their participation in the study. For 
patients who have agreed to provide their mobile number for text message reminders, this method will 
be used to supplement electronic communication reminders to encourage and facilitate intervention 
use. Mobile numbers will be collected solely for the purposes of communicating study-related 
requirements to patients and will not be used to disclose any PHI nor will they be shared for purposes 
beyond this study and without patient consent. Information detailed in text message correspondences 
will reference time points and reminders of which patients will need to: 
1. Complete a study procedure (e.g., view HOPE-Genomics platform, complete a survey)  
2. Be provided with unique survey links generated by REDCAp (i.e., links for Baseline, Pre-test 
Education, 10-day Follow-up, 3 Month Follow-up and 9 Month Follow-up surveys). 

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Patients who have opted to receive reminders through their mobile phone will receive an initial 
message acknowledging their opt-in. Frequency of follow-up reminders to complete study 
procedures will be dictated by patient preference (i.e., patients prefer reminders only by text 
message), study arm assignment, and/or with regards to timeliness of completion of study 
requirements. Frequency of text messages will mimic the schedule for automated email reminders:  
• 
Baseline Survey: every 96 hours 
• 
Pre-Test Tool Viewing (Arm 3): 24 hours after login instructions sent 
• 
Pre-Test Survey: every 96 hours 
• 
HOPE Tool Viewing (Arms 2/3): 5 days after login instructions sent 
• 
All follow-up surveys: Every 2 weeks  
There will be a total of five time points of which patients will be provided survey links through text 
message. These time points correspond to the required completion of surveys as follows:  Baseline 
survey, Pre-test Education survey, 10-day Follow-up survey, 3 Month Follow-up survey and 9 
Month Follow-up surveys.  
4.4  
Results Disclosure   
We expect results to be available within ~3-14 days of sample acquisition. We will monitor the patients’ 
laboratory data to see when results have been finalized. Lab results and variant interpretations for the 
HOPE Genomics intervention will be stored in a custom genomic database designed by COH Research 
Informatics. All results will be validated by study staff before data are input into the HOPE-Genomics 
tool. All clinicians will receive results through the EHR. Additionally, clinicians with patients in the 
intervention arm will also be able to view their patients’ results through the HOPE-Genomics after 
individual-level patient data have been entered into HOPE-Genomics. Results will be available to 
patients in the HOPE-Genomics app approximately 3-14 days after they are available in the EHR.   
At this time, we will ask patients in the Return of Results Only intervention arm, (Arm 2) and the Return 
of Results + Pre-Test Education arm (Arm 3) to log into the HOPE-Genomics tool on their own time. 
Study staff will provide patients with instructions to create an account and log into the tool using dual-
factor authentication. Study staff will track patients’ tool access through Google Analytics and call or 
send automated RedCap reminders to encourage tool use, if necessary. Study staff will track patients’ 
tool access through Google Analytics and call and/or send automated REDCap reminders to encourage 
tool use, if necessary. In addition, the study staff will be available to help patients access HOPE-
Genomics at subsequent clinic/infusion visits or via secure web conference at any point in time 
following the disclosure of their test results until the end of the study (with coordination with the study 
team).   
Patients in the control arm (Arm 1) will have their results returned in clinic by their provider, with no 
changes to the clinician’s typical delivery method. Patients will be provided an educational pamphlet 
that generally describes sequencing and will granted access to the HOPE-Genomics tool with their 
results after completing all follow-up study surveys, approximately 9 months after their results are in the 
EHR. 

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As a thank you for their participation, patients will be provided with electronic or physical gift cards 
totaling $25 throughout study participation. Patients will receive a $5 gift card after completing the 10-
day follow-up survey, a $10 gift card after completing the 3-month follow-up survey, and a $10 gift card 
after completing the 9-month survey. If patients require a separate study-specific visit to view HOPE-
Genomics, we will provide them with a valet parking voucher to facilitate in-person study activities. 
4.5 Follow up Surveys  
4.5.1 10-Day Follow-Up Survey  
All patients enrolled in the study will be asked to complete a follow-up survey approximately 10 days 
after results are released in the EHR. The survey will either be mailed to the participant, provided 
electronically and/or by text message via REDCap survey link or completed over a scheduled phone or 
Zoom call with a staff member, according to patient preference. If the survey is mailed, the patient will 
be provided with a return envelope. Follow-up survey reminders will be similar to those outlined for the 
baseline survey. The follow-up survey outcomes are detailed in Table 1. For participants of both 
intervention arms, the survey will also include questions about the usability of HOPE-Genomics. Survey 
measures will be similar to measures detailed in Section 4.1.1. 
Patients in Arm 1 (usual care) will receive a modified survey that does not contain questions that 
pertain specifically to the HOPE-Genomics tool, like usability.  
4.5.2 3 Month Follow-Up Survey  
Delivery of the follow-up survey and study materials will follow similar procedures mentioned in Section 
4.3.1. The 3 Month follow-up survey outcomes are detailed in Table 1. Survey measures will be similar 
to measures detailed in Section 4.1.1.  
4.5.3 9 Month Follow-Up Survey 
Delivery of the follow-up survey and study materials will follow similar procedures mentioned in Section 
4.4.1.  The 9 Month follow-up survey outcomes are detailed in Table 1. Survey measures will be similar 
to measures detailed in Section 4.1.1. Participants in the Usual Care Arm will view their results in the 
HOPE-Genomics tool after completing the 39Month Follow-Up Survey. None of their follow-up surveys 
will contain questions pertaining to the HOPE-Genomics tool or its usability.  
4.6 Medical Record Abstraction 
Throughout the study, study staff will perform a limited medical record abstraction of consented 
participants. Primary outcome data will include high-risk screening, surgery, chemoprevention, targeted 
therapies, genetic counseling, informing family members, and cascade testing. Covariate data will 
include sociodemographic information, cancer information, germline and somatic genomic biomarker 
testing, and dates and types of treatments for cancer. Additional outcomes are detailed in Table 1. 
5.0 DATA AND SAFETY MONITORING AND UNANTICIPATED PROBLEMS 
5.1 Definition of Risk Level 
This is a low risk study, as defined in the City of Hope Institutional Data and Safety Monitoring Plan 
(DSMP), because it involves minimal risk, as the risks of harm anticipated are not greater than those 
ordinally encountered during daily life or during the performance of routine psychological tests in a 

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healthy person. This study involves the administration of surveys before and after an educational 
intervention, which will be integrated into the patient’s usual course of clinical care. The study Principal 
Investigator is responsible for monitoring protocol conduct and reporting all reportable events to the City 
of Hope (COH) Data and Safety Monitoring Committee (DSMC) and Institutional Review Board (IRB) in 
accordance with the City of Hope Institutional Deviation policy, and Clinical Research Adverse Event 
and Unanticipated Problem policy.  
5.2 Unanticipated Problems (UP) Involving Risks to Subjects or Others 
An unanticipated problem is any incident, experience or outcome that meets all three of the following 
criteria: 
o Unexpected (in terms of nature, severity, or frequency) given the following: a) the research 
procedures that are described in the protocol-related documents such as the IRB approved 
research protocol, informed consent document or Investigator Brochure (IB); and b) the 
characteristics of the subject population being studied; AND 
o Related or possibly related to participation in the research (possibly related means there is a 
reasonable possibility that the incident, experience, or outcomes may have been caused by the 
procedures involved in the research); AND 
o Suggests that the research places participants or others at greater risk of harm (including 
physical, psychological, economic, or social harm) than previously known or recognized. 
 
Any UP that occurs during the study conduct will be reported to the DSMC and IRB in accordance with 
the City of Hope’s Institutional policy using the electronic submission system, iRIS. 
6.0 
 DATA ANALYSIS  
As noted in Section 4.0, we are administering the survey items in order to help with item reduction for 
the trial. We will generate descriptive statistics (e.g., distributions, means) in order to evaluate for 
ceiling and floor effects. An amended survey will be submitted prior to administration.  
 
Primary outcome (i.e., patient knowledge, recall rates) will be assessed at the 10-day post-disclosure 
timepoint.  
 
We will be using MRA and survey data to evaluate if participants received contextual guideline-
concordant care. This will involve review of receipt of prophylactic surgery, chemoprevention, targeted 
therapy for germline mutations, consultation with genetic counseling/ genetic specialists, informing 
family members, and family member cascade testing. To generate concordance scores for patients 
already on active therapy, patients will be asked about their current and/or planned cancer treatment at 
baseline and at each follow-up timepoint in the study (i.e., chemotherapy, radiation therapy, cancer-
directed surgery, hormone therapy, immunotherapy, and targeted therapy). Patients will be considered 
as being contextually guideline-concordant if they receive at least 75% of the recommend guidelines. In 
sensitivity analyses, we will vary the cutoff for guideline- concordance between 50% and 100%. Survey 
data will also be used to evaluate usability of the HOPE-Genomics application, the psychosocial impact 
of using the tool, engagement in care, genetic knowledge, and understanding of genomic test results 
 

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6.1 Sample Size and Accrual Rate: 
We plan to anchor our cohort on patients with somatic testing.  We expect to accrue 465 patients: 155 
per each arm. We assume that there will be a 10% attrition rate among accrued patients, leaving us 
with a final analytical sample of 390 patients. For the first 3 months, we assume that 17 patients are 
enrolled each month, during which time we will evaluate and optimize study processes. After this we 
will increase monthly accrual to 35 patients. We expect to be complete with accrual in 16 months. 
Patient participation will be approximately 7 months consisting of baseline pre-testing followed by 
genetic testing/results disclosure and then post-testing. The estimated total study time including 
analysis will be 26 months.       
 
6.2 Statistical Analysis Plan: 
 
The study data will consist of three main areas:  
 
1) patient knowledge testing and clinical care recommendations via survey-based questions  
2) patient demographic information collected via the electronic medical record (EMR); and 
3) patient clinical and treatment information collected via the EMR.   
 
This information will be used to evaluate outcomes, predictors and adjust for covariates. 
 
6.2.1 Primary Outcome 
In Aim 1, recall rates of personal genomic results at the 10-day post-disclosure timepoint for Arms 2 
and 3 of the study will be pooled together so that the main comparison is a two-sample test of 
proportions between patients under usual care (Arm 1) vs. patients with any exposure to the HOPE-
Genomics tool (Arms 2/3).  Pilot studies indicate that a recall rate for patients with an actionable 
somatic finding are approximately 39% under usual care.  An analytical sample of 390, assuming a 
39% recall rate under usual care (Arm 1: n = 130) with a 15% improvement using the tool (Arms 2/3: n 
= 260), will be sufficient to detect a difference in proportions with 80% power and alpha = 0.05 (two-
sided with no adjustment for multiplicity).  Rates of recall will be analyzed using a two group Chi-Square 
test of equal proportions, and logistic regression when controlling for covariates such as age and 
education level. The overall fit of the model will be examined using Hosmer-Lemeshow goodness-of-fit 
test and ROC curves.  If any normality issues arise, non-parametric techniques such as the Mann-
Whitney test will be deployed. Recall rates will be defined as the number of participants who correctly 
recall somatic test results, which will be assessed in the second question of the 10-day post-disclosure 
survey.  
 
6.2.2 Secondary Outcome 
In Aim 2, we will assess the effect of the intervention on the proportion of patients with contextual 
NCCN guideline-concordant care. This approach is modeled after analyses used by Dr. Robert Green 
et al. in the MedSeq CSER1 project.25,26 Operationalization of contextual guideline concordant care: In 
the primary analysis, we will assess the uptake of contextualized guideline-concordant care taking into 
account clinically relevant, patient specific circumstances. We will use clinical characteristics from the 

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EHR to assign each patient to clinical category for which there are discrete NCCN recommendations. 
Using patient self-reported baseline/T1 and EHR data, following sequencing disclosure, we will create a 
summary genetically guided care variable ranging from 0-100%. The denominator consists of the total 
number of contextual guideline-concordant interventions/behaviors possible during a 12-month period 
following results disclosure for any given patient given his/her germline findings, family history, and 
clinical characteristics. The numerator consists of the total number of patient-adopted guideline 
concordant intervention/behaviors completed during a 12-month period following results disclosure.  
For a patient found to have a pathogenic germline/actionable somatic variant, we will assign 
benchmarks of genetically guided care derived from evidence based clinical practice guidelines (i.e. 
NCCN, United States Preventive Services Task Force, or medical society based clinical guidelines). 
We convene a weekly POTB meeting where a panel of medical geneticists, cancer geneticists, genetic 
counselors, genetic nurse practitioners, oncologists, gastroenterologists, cardiologist, and hepatologist 
review cases and develop multidisciplinary contextualized guideline concordant recommendations 
(chaired by Dr. McDonnell). 
In the secondary analyses, we will define guideline concordant as meeting ≥75% of recommended 
guidelines. In sensitivity analyses, we will vary the cutoff for guideline concordance between 50% and 
100%. 
 
We will test if the use of HOPE-Genomics will result in higher rates of uptake of evidence-based 
genetically guided care (e.g., patient receipt of guideline concordant care, cascade testing) than usual 
care: Our primary goal will be to assess whether or not the uptake of contextual guideline-concordant 
care differs between the two arms. The primary objective is to test the null hypothesis of no intervention 
effect on the outcome. We expect that patients in the intervention arm will have higher rate of uptake of 
contextual guideline-guided care than patients in the control arm. A two-sided Type I error of 0.05 will 
be used for all statistical tests. We will consider two-sided p-value less than 0.05 as a statistically 
significant. Patients will be considered concordant (Y=1) if they undergo a predetermined percentage of 
genetically guided care and discordant (Y=0) otherwise. Using an intention-to-treat analysis, the 
proportion of concordant patients will be modeled using the logisitic regression approach for binary 
outcome (PROC LOGISTIC in SAS [Cary, N.C.]). We will use compound symmetry and unstructured 
working correlation matrix to account for correlation between patients within the same physician. The 
odds ratio of the concordant patients between the intervention and control arms will be calculated using 
the group coefficient in the Logistic model. The significance of the coefficient will be tested to determine 
treatment group difference. In addition, we will use Kauermann and Carroll (KC) correction for robust 
SEs if the number of physicians is small.11 To evaluate the success of randomization, we will test the 
differences in characteristics of physicians and patients between the two arms. The Logistic model will 
include statistically significant characteristics as covariates. Logistic will also be used to model the 
percentage of the rate of uptake of the genetically guided care per patient, treated as a binomial 
variable, and include the within-physician correlation, to test for treatment group difference. 
 
6.2.3 Exploratory Outcomes 
Recall rates at 3-month: Recall rates of personal genomic results at the 3-month post-disclosure 
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sample test of proportions between patients under usual care (Arm 1) vs. patients with any exposure to 
the HOPE-Genomics tool (Arms 2/3). Rates of recall will be analyzed using a two group Chi-Square 
test of equal proportions, and logistic regression when controlling for covariates such as age and 
education level. The overall fit of the model will be examined using Hosmer-Lemeshow goodness-of-fit 
test and ROC curves.  If any normality issues arise, non-parametric techniques such as the Mann-
Whitney test will be deployed. 
Concordance Score: We will also use linear regression to conduct sensitivity analysis and test if the use 
of HOPE-Genomics will result in higher rates of uptake of evidence-based genetically-guided care (e.g., 
patient receipt of guideline concordant care, cascade testing) than usual care. The created summary 
concordance score of genetically-guided care variable ranging from 0-100% will be used to as numeric 
outcome. The null hypothesis is that the concordance score is not different between arms. We will 
consider two-sided p-value less than 0.05 as a statistically significant.  
Test-related distress: We hypothesize that patients who view HOPE-Genomics will have lower test-
related distress than patients in the usual care group: Patients will be assessed at 3 post-disclosure 
time points (T1-T3) using the PAGIS Certainty Scale and the FACToR. Some patients may have little 
test-related distress, whereas others may score higher (e.g., if testing reveals cancer or non-cancer 
related disease risk). Test-related distress is thought to decrease with time from the disclosure visit. We 
will summarize test-related distress at each time point, as well as change score. We will examine 
baseline characteristics to evaluate the potential for bias. In addition to complete case analysis, 
sensitivity analyses (e.g., using weighted methods) may occur to evaluate bias. We will use clustered 
Wilcoxon test for mean score comparison between groups at each time point. In addition, mean change 
in score from T1 to T3 will be modeled using GEE model adjusting for patient characteristics. We will 
use Autoregressive (AR1) and compound symmetry working correlation matrix to account for repeated 
measurement correlation and within-physician correlation. The significance of the coefficient will be 
tested to determine difference between two groups. 
General genomic knowledge: We hypothesize that patients in the Return of Results plus Pre-test 
Education (Arm 3) arm will have better general genomic knowledge than the Return of Results only and 
Usual Care arms (Arms 1/2). To examine this, we will compare the pre/post test scores between the 
intervention group (Arm 3) and the control groups (Arms 1/2) The pre/post test scores will be calculated 
by taking the difference in score between pre/post tests and then comparing the mean differences with 
an independent T-test between control groups (Arms 1/2) versus the exclusive exposure to the HOPE-
Genomics tool educational content (Arm 3). We also hypothesize that Arm 3 will have better knowledge 
of the difference between germline and somatic testing, as measured in the modified Lung-MAP 
instrument, which has been adapted and implemented in our survey. We will test this difference as 
above, testing the mean difference in scores of the modified Lung-MAP instrument across Arms 1 and 
2 vs Arm 3. 
 
Genetically-guided care: In exploratory analyses related to Aim 2 (i.e. receipt of contextual guideline-
concordant care), we will also operationalize the secondary outcome in an additional way: Categories 
of genetically-guided care: We will evaluate patients’ receipt of 1) treatment recommended by provider 
based on sequencing (any/none), 2) patients’ sharing of sequencing results with family members 
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HOPE-Genomics tool usage: Finally, in order to understand how patients and physicians use HOPE-
Genomics and to determine whether refinements are required prior to dissemination, we will analyze 
the web-log of user visits (e.g., number of viewing sessions, page views and use of interactive 
elements). 
 
7.0 
 MONITORING AND PERSONEL RESPONSIBLE FOR MONITORING 
The Principal Investigator, collaborators, and study staff will work closely to ensure adequate 
monitoring of the study. The Principal Investigator is responsible for monitoring protocol conduct and 
reporting to the COH DSMB any adverse events related to study procedures.   
8.0  
HUMAN SUBJECT ISSUES 
We will take measures to protect patients, including the exclusion of patients who are too ill to 
participate in the study. Dr. Gray, the Co-Investigators and the Collaborating Investigators are 
experienced working with patients with cancer and have undergone training designed to ensure the 
adequate protection of human subjects.  
8.1 Potential Risks to Participation 
This study involves the completion of study-related surveys and the viewing of a computer-based 
educational too. No invasive procedures are involved and hence the physical, psychological and social 
risks to participants are minimized. The risks and discomforts of this study are minimal and may be 
associated with answering potentially sensitive questions on surveys. Data will be retrieved from 
existing medical records and laboratory results as per the research protocol needs for identifying 
patient outcomes and populating the educational intervention. Patient confidentiality will be strictly 
maintained and a breach in confidentiality is not anticipated and will be mitigated by following 
procedures detailed in Section 5, “Data and Safety Monitoring, Unanticipated Problems, and Protocol 
Compliance.” In creating a patient-facing application that discloses genetic test results, this study 
involves the transfer and storage of PHI (patient name, date of birth, medical record number, biological 
sex, cancer type, ordering provider, and genetic test results) from a password-protected database in 
REDCAp to the HOPE-Genomics platform. As mentioned in Section 4.2, each participant is assigned a 
unique FHIR ID that cannot be linked or traced back to any patient PHI. Only team members with 
appropriate administrative rights have access to participants’ FHIR IDs and corresponding MRNs. 
Further, no PHI is shared between the HOPE-Genomics platform and Google Analytics, which is purely 
used for collecting basic user engagement metrics (i.e., number of page clicks, time spent on a page in 
the tool).    
Our informatics team performs cybersecurity scans every week on the entire HOPE-Genomics 
application to look for any vulnerabilities. Any detected vulnerabilities are assessed and fixed as 
needed. 
 

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8.2 Potential Benefits to Participation 
The patients may not directly benefit from study participation.  However, the data gained through this 
study stands to potentially improve their genomic knowledge and quality of patient-centered care. In 
addition, it may improve education and care quality for future patients.  
8.3 Potential Benefits to Others 
Information from this study is expected to contribute to the understanding of how to optimally return 
genomics results to cancer patients and to better communicate important genomics concepts to 
patients. This information may be especially important as rates of genomic testing increase without 
proportional increases in clinicians to return these results. 
8.4 Alternatives to Participation 
Patients can choose not to participate, and this will not impact their medical care at City of Hope in any 
way. 
8.5 Informed Consent 
The PI or IRB-approved named designate will explain the nature, duration, purpose of the study, 
potential risks, alternatives and potential benefits, and all other information contained in the informed 
consent document. In addition, they will review the experimental subject’s bill of rights and the HIPAA 
research authorization form. Research subjects will be informed that they may withdraw from the study 
at any time and for any reason without prejudice, including as applicable, their current or future care or 
employment at COH or any other relationship they have with COH. Research subjects will be afforded 
sufficient time to consider whether or not to participate in the research. 
8.6 Registration into Clinical Trails On-Line system 
All participants of this study will be registered into OnCore at COH for this trial. 
8.7 Participant Withdrawal from Research 
At any time after signing the informed consent document, participants may elect to withdraw from 
participation in this protocol as follows: A participant may (1) withdraw from future study activities but 
permit clinical data collection to continue, (2) withdraw from future study activities and disallow the 
collection of clinical data, (3) remain amenable to study activities but disallow retention of PHI data, or 
(4) elect to withdraw completely from the study whereby all data will no longer be made available for 
research. Participant withdrawal, including the nature of withdrawal, will be documented in the Master 
List which will be kept in a password-protected file, accessible only by authorized study staff using 
secure COH computers. The request to withdraw from studies will also be documented in the patient’s 
medical record via Epic. If they do not wish to participate but are interested in exploring other options 
such as talking with their care team or a social worker, we will provide appropriate referrals. 
 
8.8 Financial Obligations and Compensation 
In the event of physical injury to a research participant resulting from research procedures, appropriate 
medical treatment will be available at the COH to the injured research participant, however, there are 
no plans to provide financial compensation. Such an event is extremely unlikely given the nature of the 
study activities.  
 

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The research participant will receive $25 for taking part in this study. For patients who choose to have 
an on-site study visit, we will also cover the cost of valet parking.  
8.9 Confidentiality  
The records related to subject identity will be kept in separate research files and will be accessible only 
to Principal Investigator and authorized study staff. Any information allowing identification of the 
subjects will not be included in any published report or any computerized records.  Data will be 
presented as aggregate or group data. The principal investigator and study staff will be the only ones 
having access to the collected data.  The results will not be available to insurance carriers or 
employers.  
The confidentiality of each participant will be rigorously maintained using existing City of Hope 
standards. HIPAA and state/federal government regulations for protecting patient privacy and security 
will be strictly observed. Researchers and staff who are not authorized to see PHI will be blocked from 
viewing PHI following HIPAA guidelines using role-based access controls. For example, unauthorized 
web app developers will not be allowed to view PHI. 
No patient or subject identifiable information will be given to third parties, including family members, 
unless that subject has given written or witnessed consent to do so. The results of research studies 
may be published but subjects will not be identified in any publication. 
9.0 DEVIATIONS  
A deviation is a divergence from a specific element of a protocol and that occurred without prior IRB 
approval.  Deviations from the approved protocol should be avoided, except when necessary to 
eliminate an immediate hazard to a research participant.  A Corrective and Preventative Action (CAPA) 
plan should be developed by the study staff and implemented promptly to avoid similar issues in the 
future.  All deviations from the protocol must be documented in study source documents and promptly 
reported to the DSMC and IRB.   
 
9.1 
Reporting Deviations 
Investigators may deviate from the protocol to eliminate immediate hazards for the protection, safety, 
and well-being of the study subjects without prior IRB approval.  For any such deviation, the PI will 
notify the DSMC and IRB, within 5 calendar days of its occurrence by electronic submission of a 
Deviation Notice via iRIS. 
 
9.2 
Single Subject Exception (SSE) Amendment Request 
Deviations from the written protocol that are not done to eliminate an immediate hazard(s) for the 
protection, safety and well-being of study subjects but may increase risk and/or alter the protocol 
integrity require prior IRB approval.  The deviation is submitted as a Single Subject Exception (SSE) 
amendment request.  An IRB approved SSE does not need to be submitted as a protocol deviation to 
 
the DSMC.  The SSE should be submitted according to the IRB guidelines and COH 
Institutional Deviation Policy and submitted via iRIS. A deviation that is not an SSE (i.e., discovered 

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after the occurrence) must be reported to the COH DSMC and IRB according to the COH Institutional 
Deviation Policy and submitted via iRIS. 
 
The main risk to participants is the potential loss of confidentiality. Participants will be assigned a 
unique study identification number that will be stored separately from personal identifiers. Study 
materials will be marked with these numbers but no other identifying information. All data will be stored 
on password-protected computers. Access to data containing personal identifiers will be secured with a 
password filing system and will be restricted to authorized study staff. All study cabinets and computer 
databases will be secured in offices that are locked when not in use. No data regarding individuals’ 
responses will be provided to any third party or to study participants. Any paper records will be kept in 
locked file cabinets for 1 year after paper publication and then destroyed. 
Another risk of this study is that participants may feel upset when answering study-related questions. If 
they feel upset during the surveys, they can stop participating at any time or choose not to answer any 
question for any reason. As noted in section 7.0, if the participant feels upset and would like referral for 
psychological counseling, the principal investigator will provide them with a referral to a mental health 
professional/social worker at City of Hope as appropriate. 
 
 
 
 
 

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10.0 
REFERENCES 
1. 
Freedman RA, Kouri EM, West DW, Keating NL. Racial/ethnic disparities in knowledge about 
one's breast cancer characteristics. Cancer. 2015;121(5):724-732. 
2. 
DA D. Mail and Internet Surveys: the Tailored Design Method. Second Edition ed. Hoboken, NJ: 
John Wiley & Sons, Inc.; 2006. 
3. 
Dillman DA SJ, Christian LM. Internet, Phone, Mail, and Mixed-Mode Surveys: the Tailored 
Design Method. Hoboken, NJ: Wiley; 2014. 
4. 
Langer MM, Roche MI, Brewer NT, et al. Development and Validation of a Genomic Knowledge 
Scale to Advance Informed Decision-Making Research in Genomic Sequencing. MDM Policy & 
Practice. 2017;2(1):2381468317692582. 
5. 
Blanchette PS, Spreafico A, Miller FA, et al. Genomic testing in cancer: patient knowledge, 
attitudes, and expectations. Cancer. 2014;120(19):3066-3073. 
6. 
Johnson LM, Sykes AD, Lu Z, et al. Speaking genomics to parents offered germline testing for 
cancer predisposition: Use of a 2-visit consent model. Cancer. 2019;125(14):2455-2464. 
7. 
!!! INVALID CITATION !!! 7. 
8. 
Read CY, Perry DJ, Duffy ME. Design and psychometric evaluation of the Psychological 
Adaptation to Genetic Information Scale. Journal of nursing scholarship. 2005;37(3):203-208. 
9. 
Sheppard VB, Graves KD, Christopher J, Hurtado-de-Mendoza A, Talley C, Williams KP. 
African American women's limited knowledge and experiences with genetic counseling for 
hereditary breast cancer. Journal of genetic counseling. 2014;23(3):311-322. 
10. 
National Cancer Institute (NCI). Health Information National Trends Survey. In. All-Adult, Full-
content, English Version. Vol HINTS 4. hintscancer.gov2011. 
11. 
Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatrica 
Scandinavica. 1983;67(6):361-370. 
12. 
Brooke J. SUS: a retrospective. J Usability Studies. 2013;8(2):29-40. 
13. 
Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the 
Acceptability E-scale for web-based patient-reported outcomes in cancer care. Applied nursing 
research : ANR. 2011;24(1):53-58. 
14. 
Charles S, Kessler L, Stopfer JE, Domchek S, Halbert CH. Satisfaction with genetic counseling 
for BRCA1 and BRCA2 mutations among African American women. Patient education and 
counseling. 2006;63(1-2):196-204. 
15. 
Centers for Disease Control and Prevention (CDC). Behavorial Risk Factor Surveillance System 
Survey Questionnaire. In. Atlanta, Georgia: U.S. Department of Health and Human Services, 
Centers for Disease Control & Prevention; 2018. 
16. 
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. 
17. 
McNaughton CD, Cavanaugh KL, Kripalani S, Rothman RL, Wallston KA. Validation of a Short, 
3-Item Version of the Subjective Numeracy Scale. Medical decision making : an international 
journal of the Society for Medical Decision Making. 2015;35(8):932-936. 
18. 
National Cancer Institute. Health Information National Trends Survey 2018. 
http://hints.cancer.gov/instrument.aspx. Published 2018. Accessed July 7, 2019. 
19. 
Best M, Newson AJ, Meiser B, et al. The PiGeOn project: protocol of a longitudinal study 
examining psychosocial and ethical issues and outcomes in germline genomic sequencing for 
cancer. BMC cancer. 2018;18(1):454. 
20. 
Idler EL, Russell LB, Davis D. Survival, functional limitations, and self-rated health in the 
NHANES I Epidemiologic Follow-up Study, 1992. First National Health and Nutrition 
Examination Survey. American journal of epidemiology. 2000;152(9):874-883. 
21. 
DeSalvo KB, Bloser N, Reynolds K, He J, Muntner P. Mortality prediction with a single general 
self-rated health question. A meta-analysis. J Gen Intern Med. 2006;21(3):267-275. 

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22. 
Basch E, Artz D, Dulko D, et al. Patient online self-reporting of toxicity symptoms during 
chemotherapy. Journal of clinical oncology : official journal of the American Society of Clinical 
Oncology. 2005;23(15):3552-3561. 
23. 
Li M, Bennette CS, Amendola LM, et al. The Feelings About genomiC Testing Results 
(FACToR) Questionnaire: Development and Preliminary Validation. Journal of genetic 
counseling. 2019;28(2):477-490. 
24. 
de Geus E, Aalfs CM, Menko FH, et al. Development of the Informing Relatives Inventory (IRI): 
Assessing Index Patients’ Knowledge, Motivation and Self-Efficacy Regarding the Disclosure of 
Hereditary Cancer Risk Information to Relatives. International Journal of Behavioral Medicine. 
2015;22(4):551-560. 
25. 
Green ED, Guyer MS. Charting a course for genomic medicine from base pairs to bedside. 
Nature. 2011;470(7333):204-213. 
26. 
Vassy JL, Christensen KD, Schonman EF, et al. The Impact of Whole-Genome Sequencing on 
the Primary Care and Outcomes of Healthy Adult Patients: A Pilot Randomized Trial. Ann Intern 
Med. 2017;167(3):159-169. 
27. 
Pedroza C, Truong VTT. Estimating relative risks in multicenter studies with a small number of 
centers — which methods to use? A simulation study. Trials. 2017;18(1):512. 
 
 
 
 
 

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11.0 
APPENDICES 
Appendix A: Physician Patient-Specific Recruitment Letter 
Helping Oncology Patients Explore- Genomics (HOPE- Genomics) Web Tool Randomized Clinical Trial 
 [DATE] 
Dear Dr. [PHYSICIAN LAST NAME], 
We are writing to you because your patient, [PATIENT NAME, MRN], is eligible for participation in the 
HOPE-Genomics research study involving a web-based, patient-facing genomic education tool.  
 
Please let us know if this is incorrect, or if you do not feel that this patient would be a good fit 
for our research study. We plan to otherwise approach your patient at a future clinic appointment or 
via email/mail/phone if we do not hear back from you over the next 24 hours. Please refer to the bottom 
of this email for the eligibility criteria of this study.  
IF YOU DO NOT WISH FOR US TO CONTACT THIS PATIENT, PLEASE LET US KNOW. We will 
otherwise proceed with approaching him/her. 
Note: If your patient enrolls in the study, your patient will have access to the HOPE-Genomics tool with 
HIS/HER genomic test results approximately 3 days after the results become available in EPIC. 
For more information or questions about the study please contact the study Principal Investigator, Stacy 
W. Gray, MD, AM, or the Clinical Research Coordinator, Marilan Luong at 310-218-1539. 
We look forward to hearing from you! 
 
Thanks so much, 
The HOPE-Genomics Team 
Dr. Stacy Gray, Marilan Luong, Madeline Currey, Sarah Labib, and Vanessa Lozano 
Division of Clinical Cancer Genomics 
Medical Oncology and Therapeutics Research 
Department of Population Sciences 
 
City of Hope Comprehensive Cancer Center 
1500 E. Duarte Road 
Duarte, CA 91010 
 
[INSERT PATIENT NAME] is eligible because [HE/SHE]: 
• 
Is receiving somatic, germline or paired somatic/germline sequencing through COH IRB 07047 
• 
Has a cancer diagnosis 
• 
Has an ECOG performance status of 0-2, and 
• 
Is fluent in English 

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Appendix B: Patient Invitation Letter 
[DATE] 
Dear [PATIENT NAME], 
This is the HOPE-Genomics Team at City of Hope. You may have received a phone call from 
[consenter] about participating in our study, involving new ways to teach patients about cancer and 
genomic testing at City of Hope. You have been selected to participate in our study because you have 
or had been diagnosed with cancer and are undergoing initial genomic testing. 
In this study, we will be testing the effectiveness of a web-based, genomic education web-app. The 
goal of this work is to understand the best ways to communicate genomic findings to patients. In this 
study, we will be asking patients to fill out a short 10-minute survey about cancer, genetics, and what 
they understand about their cancer. We will then follow up with you at 4 additional time points in the 
next 9 months and ask you to complete a survey at those times. The surveys will ask about your 
reactions to viewing the web-app, receiving your genomic test, your knowledge about cancer and 
genetics, and any changes to your medical care that may have resulted from your test. All patient 
participants will receive a $25 gift card as a “thank you” for their participation. 
We would like to make sure that cancer patients understand this type of information because doctors 
and patients often use this information to help find the right cancer care. Your participation in this study 
would be completely voluntary and there is no obligation to participate. Entry into this study will not 
involve any treatment. The study is confidential and your responses to survey questions will not be 
passed along to your medical provider or anyone outside of the study team.  
[FOR PAPER INVITATION:] If you are interested, please let us know by completing the enclosed 
interest postcard and mailing it back to us. We will then send you an online survey link or a paper 
survey with a return envelope. If you are not interested in participating, please let us know by mailing 
back the enclosed interest postcard with your response.   
[FOR REMOTE RECRUITMENT:] If you are interested, please email HOPEGenomics@coh.org or call 
[INSERT CRA’s COH PHONE NUMBER] to complete consent over the phone.  
If you have any questions about this research study, please call the Principal Investigator, Stacy W. 
Gray at 626-218-8662, or the Clinical Research Coordinator, Marilan Luong at 310-218-1539. You can 
also reach the Institutional Review Board at City of Hope by calling 626-216-2700. 
 
Thank you so much, 
The HOPE-Genomics Team 
Dr. Stacy Gray, Marilan Luong, Madeline Currey, Sarah Labib, and Vanessa Lozano 
Division of Clinical Cancer Genomics 
Medical Oncology and Therapeutics Research 
Department of Population Sciences 
 
City of Hope Comprehensive Cancer Center 
1500 E. Duarte Road 

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Duarte, CA 91010 
 
 
 

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Appendix C: Patient Invitation Phone Script 
 
Hello, my name is [CRA NAME] and I am a clinical research assistant at City of Hope. Is there a [(Mr. 
Ms) PATIENT NAME] here? 
 
Hi [(Mr. Ms) PATIENT NAME] You may recall recently consenting to receive genetic testing through 
City of Hope’s Precision Medicine Program. Does that sound familiar?  
 
IF YES: I am part of a research team in the genetics department at City of Hope and I am reaching out 
to you because my team and I are hoping that you will be willing to participate in a research study in 
which we are looking at new ways  to show genomic information to City of Hope patients that will 
hopefully better explain what their genetic test results mean. We’d like to tell you more about the study 
and next steps. Is this a good time to talk? 
   
[IF NO: thank them and schedule a time to call back]  
 
IF YES: You were selected to participate in our study because you have/had been diagnosed with 
cancer and are having genomic testing through the City of Hope Precision Medicine program . In the 
current study, we are evaluating new ways of showing genomic information to City of Hope patients. 
We want patients like you to be able to access their test results in a patient-friendly way, so we have 
developed a web-based cancer tool, called HOPE-Genomics, which educates patients about their 
genomic test results and provides patient and their family with helpful resources. In this study, we want 
to show patients this tool and then get their feedback through five short surveys over the span of 12 
months. Each survey takes at least 15-30 minutes to complete. This study does not involve any 
treatment for you; it is purely feedback-based. Although we cannot pay you for participating in the 
study, we would like to reimburse you for your time with three gift cards totaling $25 over the span of 
the study.  Your participation in this study would be completely voluntary and there is no obligation to 
participate.  Is this something you would be interested in?   
[If Yes go to 3a]   
[IF NO: thank them for their time and end call]  
 
IF YES: Great! In order to participate, we need to go over the study details and receive your verbal 
consent for participation. Is this a good time to complete the consent? It should take 10-15 minutes. [IF 
YES: complete verbal consent with patient and let them know about next steps; IF NO: thank them and 
schedule a time to call back.]  
 
 
 
 

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Appendix D: Patient Reminder Letter 
[DATE] 
Dear [Patient Name], 
 
This is the HOPE-Genomics Team at City of Hope. A few weeks ago, we contacted you inviting you to 
participate in a research study involving new ways to teach patients about cancer and genomic testing 
at The City of Hope Comprehensive Cancer Center. We are contacting you because we have not 
received a response regarding your interest in participating in this study.  
 
In this study, we will be testing the effectiveness of a genomic education web-app. The goal of this work 
is to understand the best ways to communicate genomic findings to patients. In this study, we will be 
asking patients to fill out a 25-minute survey about cancer, genetics, and what they understand about 
their cancer. We will then follow up with you at 4 additional time points in the next 9 months and ask 
you to complete a survey at those times. The surveys will ask about your reactions to viewing the tool, 
receiving your genomic test, your knowledge about cancer and genetics, and any changes to your 
medical care that may have resulted from your test. All patient participants will receive a $25 gift card 
as a “thank you” for their participation. 
We would like to make sure that cancer patients understand this type of information because doctors 
and patients often use this information to help find the right cancer care. Your participation in this study 
would be completely voluntary and there is no obligation to participate. Entry into this study will not 
involve any treatment. The study is confidential and your responses to survey questions will not be 
passed along to your medical provider or anyone outside of the study team.  
[FOR PAPER INVITATION:] If you are interested, please let us know by mailing back the enclosed 
postcard. Alternatively, you can also email HOPEGenomics@coh.org or call [CRA’S COH PHONE 
NUMBER] to complete consent over the phone. We will then send you an online survey link or a paper 
survey with a return envelope. If you are not interested in participating, please let us know by 
responding to this email or mailing back the enclosed interest postcard with your response.   
[FOR REMOTE RECRUITMENT/EMAIL:] If you are interested, please email HOPEGenomics@coh.org 
or call [CRA’S COH PHONE NUMBER] to complete consent over the phone. We will then send you an 
online survey link or a paper survey with a return envelope.  
 
If you are not interested, please let us know. If you have any questions about this research study, 
please call the Principal Investigator, Stacy Wang Gray at 626-218-8662 or the Clinical Research 
Coordinator, Marilan Luong at 310-218-1539.  
 
You can also reach the Institutional Review Board at City of Hope by calling 626-216-2700. 
 
Thank you so much, 
 
The HOPE-Genomics Team 
Dr. Stacy Gray, Marilan Luong, Madeline Currey, Sarah Labib, and Vanessa Lozano 

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Division of Clinical Cancer Genomics 
Medical Oncology and Therapeutics Research 
Department of Population Sciences 
 
City of Hope Comprehensive Cancer Center 
1500 E. Duarte Road 
Duarte, CA 91010 
 
 
 
 
 

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Appendix E: Patient Interest Postcard 
Front of postcard: 
 
 
Back of postcard: 
 
 
 
 
 
 
 
 
 
 
 
If you are not interested in participating, please check off the box below and mail 
this postcard back.  Thank you! 
 
I have received and reviewed the information related to the HOPE study.   
 
I am interested in participating. Please contact me to discuss the study.  
 
I am not interested in participating.  Please remove my name from the contact list. 
Study ID: ___________ 

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Appendix F: Patient Verbal Consent Phone Script 
 
Hello, my name is [CRA NAME] and I am a clinical research assistant at City of Hope. Is there a [(Mr. 
Ms) PATIENT NAME] here? 
 
Hi [(Mr. Ms) PATIENT NAME], is now a good time to talk?  
 
[IF NO: schedule a time to talk to patient] 
 
[IF YES] I am reaching out to you today because you recently expressed an interest in participating in 
our HOPE-Genomics study, which explores new ways of teaching patients about their cancer and 
genomic testing at City of Hope. Does this sound familiar?  
 [IF NO] That’s okay, I can provide you with a quick summary.  
You received information about the study in an email, in the mail, by phone, or from a clinical research 
assistant during one of your clinic visits. As previously explained, we are looking at new patient-friendly 
ways of showing genomic information  to patients at City of Hope that will hopefully better explain what 
their genetic test results means. One of these methods is a web-based cancer tool we have developed 
for patients, called HOPE-Genomics, which educates patients about their genomic test results and 
provides patients with helpful resources.  We will be asking patients to complete five short surveys 
about their knowledge of cancer and genomic testing over the span of twelve months.  Does this sound 
familiar? 
[IF STILL NO] thank them and end the call.  
Start here if right after phone invitation script: [IF YES] 
Great. First, thank you so much for expressing interest in participating in our study. I am contacting you 
today to briefly go over what your participation would entail in this study, your rights as a research 
participant in this study, answer any questions you may have, and then document your consent to 
participate. We will also talk about next steps in the study, if you decide to participate.  If you have any 
questions along the way, feel free to stop me. I will also be (emailing/mailing) you the complete consent 
form after our conversation, which will elaborate further on everything we discuss today. Do you have 
any questions for me before we begin? 
[IF YES, answer questions before moving on] 
If you agree to participate in this study, you will be randomly placed into 1 of 3 study groups. 
Randomization means that you will be put into a group by chance, like pulling a number out of a 
hat. Depending on the group you are randomly placed into, you will view the HOPE-Genomics 
tool at different time intervals during your participation in this study. Regardless of which group 
you are placed in, you will participate in: 

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• 
5 brief surveys within the next 12 months. Each survey will take at least 15-30 minutes to 
complete. These surveys will ask you questions about cancer, genomics, and what you 
understand about your cancer and genomic testing results. Although we would love for 
you to complete the survey in full, we do understand that some questions may be difficult 
for you to answer. If so, you have the option to skip questions you are not comfortable 
answering and/or you do not know the answer to by selecting the “do not know” option. 
o Please keep in mind that although you are considered to be "on-study" for 12 
months, this does not mean we will require your active engagement each month. 
I will go into more detail of when you will be asked to actively participate and will 
provide you with a calendar so that you can better understand when those time 
points will be.  
• 
You will be asked to use an online cancer tool we have developed. Depending on the 
group you are placed into, you may be asked to use the tool one time or two times. This 
may occur at any time during the 12-month span of the study.  Our study team will 
provide you with login information so you can view the tool’s education and resources on 
your own time. 
• 
We are also asking your permission to review your medical records so that we can learn 
about your health, the care you are receiving at COH, and about the genomic testing 
that you have had, if any.  
As I mentioned before, we truly appreciate the time and feedback you will be giving to this study, so we 
will be providing you with three gift cards totaling $25 over the span of the study. You will receive a $5 
gift card after completing your third survey, a $10 gift card after completing your fourth survey, and 
another $10 gift card after completing your fifth survey.  
I would like to remind you that your participation in this research study is completely voluntary. You are 
free to withdraw your consent for participation at any time without penalty. Choosing not to participate 
will not affect your ability to receive care at City of Hope.  
You may benefit directly from participation in this study by learning more about cancer genomics, your 
genomic testing results and an understanding of the genetic make-up of your cancer and normal cells. 
In addition, patients in the future may potentially benefits from the knowledge gained from your 
participation.  
All information learned from this study will be kept confidential and secured in the principal 
investigator’s office. We do not share any of your information with outside parties or third parties. If, 
despite our best efforts, identifying information about you is released, it could negatively impact you. 
However, this risk is small.  
I know I just shared a lot of information with you. To summarize, you will be completing 5 surveys over 
the span of 12 months and will be viewing the online tool at designated times. Do you have any 
questions or concerns regarding the tasks you are being asked to complete over the next 12 months?  
Do you think you have the time to participate in this study? There is no pressure to say “yes.”  
 For documentation purposes, Do you consent to participate in the HOPE-Genomics Study? 

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[IF NO] Thank them for their time and participation thus far.  Rest assured that all the information they 
provided for this study will be removed. 
[IF YES] Great! Thank you so much for joining our study. As a next step in participation, we will be 
sending you a brief initial survey that will ask you a little about yourself, if you have had genomic testing 
in the past, and about genomics in general. We can email you a link to complete the survey 
electronically, or we can provide you with a hard copy of the survey. Which is more convenient for you?  
[IF EMAIL] Great. Can you please confirm your email address with me?  
[TEXT MESSAGING] Additionally, you have the option to receive updates related to study participation 
and to receive survey links via text message (standard text messaging rates will apply). Your decision 
to receive text message notifications is entirely voluntary. If you decide to receive text messages, you 
may decide at any time that you no longer want to receive them and may cancel by contacting the 
HOPE-Genomics study team.  Your decision to use the service will not affect your ability to take part in 
this study.  
Texting over mobile phones does carry security risks because text messages are not encrypted. This 
means that information you receive by text message could be intercepted or viewed by an unintended 
recipient or by your mobile phone provider or carrier. To minimize risks, the messages will not identify 
you individually and will not include any reference to your course of care at City of Hope. We will not 
disclose your mobile phone number to anyone outside of this study without your prior permission and 
consent. If you decide to opt-in for the text message reminders, you may receive:  
• 
Reminder messages to complete a study procedure (e.g., viewing the platform or completing a 
survey) (up to 5 messages per study activity)  
• 
Messages with unique survey links (up to 5 messages, total)  
The cost of messages will vary depending on your mobile carrier and on your per message transaction 
cost. You can consult your mobile carrier regarding your per message transaction cost.  
Would you like to opt-in to receive text message reminders at this time? You can also make the 
decision later on by contacting our research team. Please take as much time as you like to decide. 
[Record answer if given: Yes/No] 
[IF YES] Can you please confirm the mobile phone number you would like to receive the reminder 
messages at?  
[IF HARD COPY]: Sounds good. Because mailing can cause delays in the study, we would be happy to 
meet you at an upcoming clinic visit to provide you with a hard copy directly. Or we can schedule a time 
to complete the survey over the phone together and then mail you a hard copy of the survey for your 
records. Are either of those options convenient for you?” 
I will send you the survey right after this meeting. We ask that you please complete the first survey at 
your earliest convenience, ideally within the next two days. As I mentioned earlier, I will be 
emailing/mailing the complete consent form to you after our meeting which goes into greater detail on 
what we discussed today. You don’t need to sign it. It is just for your records and reference. I will also 

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be sending you a calendar outlining when you can expect to look at the HOPE Genomics tool and 
complete surveys over the next 12 months. If at any point there are any life events, such as vacations 
or medical treatment that will impede you from completing study activities, please let me know so we 
can best accommodate to your schedule. You can expect a few calls from me over the next few weeks 
to check in with you. Is there an ideal time that you would like me to call?  [Make note of time] 
Do you have any last-minute questions for me? If any additional questions arise, feel free to reach out 
to our team at any time. Our contact information is in the consent form, and I will also include it in the 
follow-up email after this meeting.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix G: Patient Script to Setup Access to HOPE-Genomics tool – RoR + Intervention Arm 
Dear [PATIENT NAME], 
This is the HOPE-Genomics Team from City of Hope. You may remember speaking with [consenter] 
about your participation in the HOPE-Genomics study, involving a web-based education tool for 
patients with genetic testing at City of Hope. Thank you for completing your first survey for the study!  
At this time, we would like to invite you to log into and view the HOPE-Genomics before your results are 
ready. The tool contains helpful information, including a video, that explains the details of genomic 
testing and its implications for your health. You may log into the tool by clicking the following link: 
https://hopegenomics.coh.org/login.  
Once you have viewed the tool, we will send you a follow-up survey. We have also attached 
instructions on how to access the tool.  
If you have any problems accessing the tool, we can accommodate in-person visits at City of Hope 
Duarte campus or remote visits using web conferencing (i.e. Zoom). Please call [INSERT CRA’s 
PHONE NUMBER] or email us at HOPEGenomics@coh.org if you would like to schedule an 
appointment to speak with study staff. 
If you have any additional questions about this research study, please call the Principal Investigator, 
Stacy Wang Gray at 626-218-8662 or the Clinical Research Coordinator, Marilan Luong at 310-218-
1539. You can also reach the Institutional Review Board at City of Hope by calling 626-216-2700. 
Thank you for all your help with our research at City of Hope, and we look forward to hearing from you!  
The HOPE-Genomics Team 
Dr. Stacy Gray, Marilan Luong, Madeline Currey, Sarah Labib, and Vanessa Lozano 
Division of Clinical Cancer Genomics 
Medical Oncology and Therapeutics Research 
Department of Population Sciences 
 
City of Hope Comprehensive Cancer Center 
1500 E. Duarte Road 
Duarte, CA 91010 
 
 
 
 

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Appendix H: Patient Script to Invite Viewing of Tool w/ Results – Either Intervention Arm 
 
Dear [PATIENT NAME], 
This is the HOPE-Genomics Team at City of Hope. You may remember speaking with [consenter] 
about your participation in the HOPE-Genomics study, involving a web-based education tool for 
patients with genetic testing at City of Hope.  Thank you for completing your first two surveys for the 
study! 
At this time, we would like to invite you to log into the tool to view your genetic test results. You 
may log into the tool by clicking the following link: https://hopegenomics.coh.org/login.  
Once you have viewed the tool, we will send you a follow-up survey. We have also attached 
instructions for viewing the tool.  
If you have any problems accessing the tool, we can accommodate in-person visits at City of Hope 
Duarte campus or remote visits using web conferencing (i.e. Zoom). Please call [INSERT CRA’S 
PHONE NUMBER] or email us at HOPEGenomics@coh.org if you would like to schedule an 
appointment to speak with study staff. 
If you have any additional questions about this research study, please call the Principal Investigator, 
Stacy Wang Gray at 626-218-8662 or the Clinical Research Coordinator, Marilan Luong at 310-218-
1539. You can also reach the Institutional Review Board at City of Hope by calling 626-216-2700. 
Thank you for all your help with our research at City of Hope, and we look forward to hearing from you!  
The HOPE-Genomics Team 
Dr. Stacy Gray, Marilan Luong, Madeline Currey, Sarah Labib, and Vanessa Lozano 
Division of Clinical Cancer Genomics 
Medical Oncology and Therapeutics Research 
Department of Population Sciences 
 
City of Hope Comprehensive Cancer Center 
1500 E. Duarte Road 
Duarte, CA 91010 
 
 
 
 

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Appendix I: Baseline Survey Invitation Letter  
Dear [PATIENT NAME],  
This is the HOPE-Genomics Team at City of Hope. You may remember speaking with [consenter] 
recently about your participation in the HOPE-Genomics study. Thank you for your willingness to 
participate in our research study involving new ways to teach patients about cancer and genetics. It 
was a pleasure speaking with you! 
As we discussed, the first step in the study is to complete a survey about yourself, your cancer care, 
and your understanding of genetics. This survey takes at least 15-30 minutes to complete. Please 
complete the following survey, using the provided study ID: [INSERT REDCAP STUDY ID]. 
[For REDCap]. You can access the baseline survey at this link: [LINK] 
[PAPER ONLY]. Please complete the attached baseline survey and mail it back to us in the enclosed 
self-addressed return envelope.  
We have attached two documents to this letter: (1) a pamphlet with information about genomic testing, 
and (2) an information sheet with further details about the HOPE-Genomics study. 
Participation in this study will not involve any treatment. The study is confidential and your responses to 
survey questions will not be passed along to your medical provider or anyone outside of the study 
team.  
If you have any questions about this research study, please call [CONSENTER’S NAME] at [INSERT 
CONSENTER’S PHONE NUMBER], or the Principal Investigator, Stacy W. Gray at 626-218-8662 or 
the Clinical Research Coordinator, Marilan Luong at 310-218-1539. You can also reach the Institutional 
Review Board at City of Hope by calling 626-216-2700.  
Thank you so much,  
The HOPE-Genomics Team 
Dr. Stacy Gray, Marilan Luong, Madeline Currey, Sarah Labib, and Vanessa Lozano 
Division of Clinical Cancer Genomics 
Medical Oncology and Therapeutics Research 
Department of Population Sciences 
 
City of Hope Comprehensive Cancer Center 
1500 E. Duarte Road 
Duarte, CA 91010 
 
 
 
 
 
 
 
 

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Appendix J: Pre-Test Survey Invitation Letter 
Dear [PATIENT NAME],  
This is the HOPE-Genomics team at City of Hope. You may remember speaking with [consenter] 
recently about your participation in the HOPE-Genomics study.  Thank you  for completing your first 
survey!  
In preparation for your genomic testing, you may have received education materials and/or resources 
about cancer and genomic testing. The next step in the study is to complete a survey about your 
knowledge of genetics. The survey should take approximately 10 minutes. Please complete the 
following survey, using the provided study ID: [INSERT REDCAP STUDY ID]. 
[For REDCap]. You can access the pre-test survey at this link: [LINK] 
[PAPER ONLY]. Please complete the attached survey and mail it back to us in the enclosed self-
addressed return envelope. 
Participation in this study will not involve any treatment. The study is confidential and your responses to 
survey questions will not be passed along to your medical provider or anyone outside of the study 
team.  
If you have any questions about this research study, please call [CONSENTER’S NAME] at [INSERT 
CONSENTER’S PHONE NUMBER], or the Principal Investigator, Stacy W. Gray at 626-218-8662 or 
the Clinical Research Coordinator, Marilan Luong at 310-218-1539. You can also reach the Institutional 
Review Board at City of Hope by calling 626-216-2700.  
Thank you so much,  
The HOPE-Genomics Team 
Dr. Stacy Gray, Marilan Luong, Madeline Currey, Sarah Labib, and Vanessa Lozano 
Division of Clinical Cancer Genomics 
Medical Oncology and Therapeutics Research 
Department of Population Sciences 
 
City of Hope Comprehensive Cancer Center 
1500 E. Duarte Road 
Duarte, CA 91010 
 
 
 
 
 
 
 
 
 
 
 

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Appendix K: Follow-Up Survey Invitation Letter (10 day/3 month/9 month for Intervention Arms)  
 
Dear [PATIENT NAME],  
This is the HOPE-Genomics team at City of Hope. You may remember speaking with [consenter] 
recently about your participation in the HOPE-Genomics study. Thank you for viewing your genomic 
test results in the HOPE-Genomics tool for patients at City of Hope! 
To help us make this tool the best it can be, we would love to hear your thoughts. There will be 3 follow-
up surveys, approximately 10 days, 3 months, & 9 months after receiving your genomic test results. 
This is the [SURVEY NAME]. This survey will ask you about cancer, genetics, and what you 
understand about your genetic testing results and cancer. The survey may also ask you about your 
experience viewing your test results in the HOPE-Genomics tool. Some of the questions may look 
familiar from an earlier survey. We would like you to complete this survey as well.  
[For REDCap]. You can access the [SURVEY NAME] online by using this link: [LINK]. Please complete 
the survey, using the provided study ID: [INSERT STUDY ID].  
[PAPER ONLY]. Please complete the attached survey and mail it back to us in the enclosed self-
addressed return envelope.  
After completing this survey, you will be provided with a INSERT 5/$10] gift card as a thank you for your 
time and feedback.   
Participation in this study will not involve any treatment. The study is confidential and your responses to 
survey questions will not be passed along to your medical provider or anyone outside of the study 
team.  
If you have any questions about this research study, please call [CONSENTER’S NAME] at [INSERT 
CONSENTER’S PHONE NUMBER], or the Principal Investigator, Stacy W. Gray at 626-218-8662 or 
the Clinical Research Coordinator, Marilan Luong at 310-218-1539. You can also reach the Institutional 
Review Board at City of Hope by calling 626-216-2700.  
Thank you so much,  
The HOPE-Genomics Team 
Dr. Stacy Gray, Marilan Luong, Madeline Currey, Sarah Labib, and Vanessa Lozano 
Division of Clinical Cancer Genomics 
Medical Oncology and Therapeutics Research 
Department of Population Sciences 
 
City of Hope Comprehensive Cancer Center 
1500 E. Duarte Road 
Duarte, CA 91010 
 
 
 

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Appendix L: 10-Day Follow-Up Survey Invitation Letter (10 day/3 month/9 month for Usual Care 
Arm)  
 
Dear [PATIENT NAME],  
This is the HOPE-Genomics Team from City of Hope. We are reaching out to you because you recently 
received your genomic test results from your healthcare provider at the City of Hope Comprehensive 
Cancer Center. Thank you very much for expressing interest in providing feedback about your 
experience through a follow-up survey! 
We would love to hear your thoughts on receiving your genomic test results. There will be 3 follow-up 
surveys, approximately 2 weeks, 3 months, & 9 months after receiving your genomic test results. This 
is the [SURVEY NAME]. This survey will ask you about cancer, genetics, and what you understand 
about your genetic testing results and cancer. Some of the questions may look familiar from an earlier 
survey. We would like you to complete this survey as well.  
 [For REDCap]. You can access the 10-day follow-up survey by clicking this link. [LINK]. Please 
complete the survey, using the provided study ID: [INSERT STUDY ID].  
[PAPER ONLY]. Please complete the attached survey at your earliest convenience and mail it back to 
us in the enclosed self-addressed return envelope.  
After completing this survey, you will be provided with a INSERT 5/$10] gift card as a thank you for your 
time and feedback.   
Participation in this study will not involve any treatment. The study is confidential and your responses to 
survey questions will not be passed along to your medical provider or anyone outside of the study 
team.  
If you have any questions about this research study, please call [CONSENTER’S NAME] at [INSERT 
CONSENTER’S PHONE NUMBER], or the Principal Investigator, Stacy W. Gray at 626-218-8662 or 
the Clinical Research Coordinator, Marilan Luong at 310-218-1539. You can also reach the Institutional 
Review Board at City of Hope by calling 626-216-2700.  
Thank you so much,  
The HOPE-Genomics Team 
Dr. Stacy Gray, Marilan Luong, Madeline Currey, Sarah Labib, and Vanessa Lozano 
Division of Clinical Cancer Genomics 
Medical Oncology and Therapeutics Research 
Department of Population Sciences 
 
City of Hope Comprehensive Cancer Center 
1500 E. Duarte Road 
Duarte, CA 91010 
 
 

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Appendix M: Patient Script Inviting Remote Tool Viewing w/ Test Results  
 
Hello, my name is [YOUR NAME] and I am a clinical research assistant at City of Hope is there a [(Mr. 
Ms) PATIENT NAME] here? 
Hi Mr/Ms. [PATIENT NAME]. I am reaching out to you because you recently agreed to participate in our 
HOPE-Genomics study, in which patients are receiving and reviewing their genetic test results through 
our HOPE-Genomics App or website. Does this sound familiar? 
 [IF NO] That’s okay, I can provide you with a quick summary.  
For this study you were approached by me or another clinical research assistant either in clinic or via 
phone to be consented in a study, that your physician or genetic counselor may have mentioned to you 
in your appointment. For this study we are testing our HOPE-Genomics app or website with patients to 
help patients review their genetic test results. After this initial consent, you may have completed a 
survey about cancer and genetics at the clinic or chosen to complete it at home on paper or through a 
survey link. Does this sound familiar? 
[IF STILL NO] thank them and end the call.  
[IF YES] Great. First, thank you very much for participating in our study. I am contacting you because 
the next phase of your participation in the study is to review your genetic tests results via our tool. Did 
you receive your login information via email? 
[IF NO] That’s okay, I can provide you with that information now. 
[PROVIDE LOGIN INFORMATION] 
[IF YES] 
Have you had an opportunity to view the tool?  
[IF NO] 
Are you having any trouble accessing the tool? 
[IF YES] 
We would be happy to assist you troubleshoot this issue now. Do you have a few minutes to do so 
now? 
[IF NO] 
I would be happy to schedule an appointment to discuss this in the next few days. Unfortunately, we 
have had some recent procedural changes at our institution due to COVID-19, which limit our ability to 
meet with patients in person. As such, we are primarily meeting with patients via web conference (i.e. 
Zoom) or phone. Would you like to schedule a time to meet with one of our study staff? 

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[IF YES] 
Great! Thank you so much for accommodating us. [SCHEDULE TIME] 
[IF NO] Thank them for the participation thus far and let them know that unfortunately we cannot 
continue with the study unless they have access to the tool.  Rest assured that all the information you 
provided for this study will be removed.  
If you have any questions about this research study, please call me at [INSERT CRA’S PHONE 
NUMBER], or the Principal Investigator, Stacy Wang Gray at 626-218-8662 or the Clinical Research 
Coordinator, Marilan Luong at 310-218-1539. You can also reach the Institutional Review Board at City 
of Hope by calling 626-216-2700. 
 
 
 

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Appendix N: Patient Incentive Letter 
 
[DATE] 
Dear Mr./Ms. [LAST NAME], 
This is the HOPE-Genomics Team from City of Hope. We are writing to you because you recently 
received your genomic testing results and completed a follow-up survey as part of our research study at 
the City of Hope Comprehensive Cancer Center.  Thank you so much for participating – your feedback 
has been very helpful thus far! 
Enclosed, please find your [INSERT $ AMOUNT] gift card as a thank you for your participation so far. 
If you have any questions about this research study, please call [CONSENTER’S NAME] at [INSERT 
CONSENTER’S PHONE NUMBER], or the Principal Investigator, Stacy W. Gray at 626-218-8662 or 
the Clinical Research Coordinator, Marilan Luong at 310-218-1539. You can also reach the Institutional 
Review Board at City of Hope by calling 626-216-2700. 
Thank you very much again for your participation! 
The HOPE-Genomics Team 
Dr. Stacy Gray, Marilan Luong, Madeline Currey, Sarah Labib, and Vanessa Lozano 
Division of Clinical Cancer Genomics 
Medical Oncology and Therapeutics Research 
Department of Population Sciences 
 
City of Hope Comprehensive Cancer Center 
1500 E. Duarte Road 
Duarte, CA 91010 
 
 
 
 
 
 
 

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Appendix O: Patient Knowledge Answers & Genomic Information Letter 
[DATE] 
 
Dear [Patient Name], 
 
This is the HOPE-Genomics Team at City of Hope. We are writing to you because you recently 
participated in our research study at The City of Hope. In the research study we are developing ways to 
teach patients about cancer and genomic testing.  For this study, you completed a short survey about 
cancer and genetics.  Thank you so much for participating – your responses have been very helpful! 
 
On your survey, you indicated that you would like to receive information on cancer genomic testing, as 
well as the correct answers to the survey questions about genetics.  In the enclosed package, we are 
including both an information sheet that has resources and links for cancer genomic testing, as well as 
a copy of the correct answers for the genetics questions from the survey. 
 
If you have any questions about this research study, please call [CONSENTER’S NAME] at [INSERT 
CONSENTER’S PHONE NUMBER], or the Principal Investigator, Stacy W. Gray at 626-218-8662 or 
the Clinical Research Coordinator, Marilan Luong at 310-218-1539. You can also reach the Institutional 
Review Board at City of Hope by calling 626-216-2700. 
 
Thank you very much again for your participation! 
 
The HOPE-Genomics Team 
Dr. Stacy Gray, Marilan Luong, Madeline Currey, Sarah Labib, and Vanessa Lozano 
Division of Clinical Cancer Genomics 
Medical Oncology and Therapeutics Research 
Department of Population Sciences 
 
City of Hope Comprehensive Cancer Center 
1500 E. Duarte Road 
Duarte, CA 91010 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Information on Cancer Genomic Testing 
 
What is cancer genomic testing? 
Genomic testing is the process of looking closely at your genes. Genes are the instructions to make 
everything in our bodies work. Some genes can tell us how tall we will be or our eye color. Other genes 
help us fight cancers. Genes are made up of an instructional code, called “DNA”. 
 
Your doctor might order cancer genomic testing from two places (and sometimes, both!): 
 
1. Cancer cells (i.e. DNA from a tumor). These usually come from a biopsy sample. Looking 
at genes from your cancer cells can help your medical team find more options, and/or 
understand the prognosis (forecast or likely course of your cancer). 
 
2. Normal cells (i.e. DNA from non-cancer cells). These usually come from a blood sample 
or cheek cells. Testing these can clarify if your family members may be at higher risk for 
cancer, and help you and your care team figure out how to potentially reduce cancer risk for 
yourself and your family members. 
 
 
When testing either cancer or normal cells, it is possible it may not find helpful information, and at times 
may not work.  It is up to you and your care team to decide if testing is right for you, and what types of 
testing might be helpful.  
 
The following are general questions about cancer and genetics  
1. Cancer is uncontrolled cell growth.  
True 
2. All cancers are aggressive.  
False 
3. Cancer is caused by a combination of 
inheritance, environmental, and lifestyle 
factors. 
True 
4. Hereditary (inherited within families) 
forms of cancer are common.  
False 
5. Any genetic change within a cell will give 
rise to cancer.  
False 
6. Cancers are usually caused by a change 
to a single gene.  
False 
7. All cancers have the same gene changes.  False 
 
The following questions ask about how genetic testing can be used in cancer care.  
 
In general, genetic testing can be used to… 
8. Confirm a  cancer diagnosis (tell where in 
the body a cancer started) 
True 
9. Find out the cancer “stage” (for example, 
stage I or stage IV) 
False 
10. Help select a cancer treatment 
True 
11. Determine exactly when a person will 
develop cancer.  
False 
12. Help predict if a cancer treatment will 
work.  
True 

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13. Help select a research study (clinical trial) 
True 
14. Help to confirm if a cancer treatment is 
working.  
True 
15. Find out where cancer is located in the 
body (for example, in the lung or colon) 
False 
16. Help predict if a person has a better or 
worse than average outlook (prognosis) 
than other patients who have the same 
type of cancer 
True 
17. Find out if the cancer has spread beyond 
where it started in the body 
False 
18. Find out if a person’s family members 
might have an increased risk of 
developing cancer 
True 
19. Help predict the chances that the cancer 
will come back after treatment 
True 
20. Find out if a person has an increased risk 
of developing cancer 
True 
21. Find out if a person (and possibly their 
family members) have a higher risk of 
developing a health condition other than 
cancer (for example heart disease or 
high cholesterol). 
True 
 
 
The following questions ask about your understanding of the differences between genetic 
testing in CANCER CELLS and NORMAL CELLS.  
 
22. Finds gene changes that a patient was born with 
Normal Cells 
23. Finds gene changes that have happened over a patient’s 
lifetime 
Cancer Cells 
24. Can be used to help select a cancer treatment for a patient 
Both 
25. Can reveal information about a patient’s risk of developing 
cancer in the future  
Both 
26. Finds gene changes that are NOT inherited and that cannot 
be passed from parents to children 
Cancer Cells 
27. Can reveal results that have unknown health implications  
Both 
28. Commonly can suggest health risks for a patient’s family 
members 
Normal Cells 
  
 
Genes 
29. Genes are made of DNA 
True 
30. Genes affect health by influencing the proteins our 
bodies make 
True 
31. All of a person’s genetic information is called his or her 
genome. 
True 
32. A person’s genes change completely every 7 years.* 
False 
33. The DNA in a gene is made of four building blocks (A, 
C, T, and G). 
True 

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34. Everyone has about 20,000 to 25,000 genes. 
True 
Genes and 
health 
35. Gene variants can have positive effects, harmful 
effects, or no effects on health. 
True 
36. Most gene variants will affect a person’s health.* 
False 
37. Everyone who has a harmful gene variant will 
eventually have symptoms.* 
False 
38. Some gene variants have a large effect on health while 
others have a small effect. 
True 
39. Some gene variants decrease the chance of developing 
a disorder. 
True 
40. Two unrelated people with the same genetic variant will 
always have the same symptoms.* 
False 
How genes are 
inherited in 
families 
41. Genetic disorders are always inherited from a parent.* 
False 
42. If only one person in the family has a disorder it can’t be 
genetic.* 
False 
43. Everyone has a chance for having a child with a genetic 
disorder. 
True 
44. A girl inherits most of her genes from her mother while 
a boy inherits most of his genes from his father.* 
False 
45. A mother and daughter who look alike are more 
genetically similar than a mother and daughter who do 
not look alike.* 
False 
46. If a parent has a harmful gene variant, all of his or her 
children will inherit it.* 
False 
47. If one of your parents has a gene variant, your brother 
or sister may also have it. 
True 
Whole Exome 
Sequencing 
48. Whole exome sequencing can find variants in many 
genes at once. 
True 
49. Whole exome sequencing will find variants that cannot 
be interpreted at the present time. 
True 
50. Whole exome sequencing could find that you have a 
high risk for a disorder even if you do not have 
symptoms. 
True 
51. Your whole exome sequencing may not find the cause 
of your disorder even if it is genetic. 
True 
52. The gene variants that whole exome sequencing can 
find today could have different meanings in the future 
as scientists learn more about how genes work. 
True 
53. Whole exome sequencing will not find any variants in 
people who are healthy.  
False 
 
 
Resources 
 
Cancer Genomics 
What is Cancer Genomics? (NIH): 
https://cancergenome.nih.gov/cancergenomics/whatisgenomics/whatis 
• 
Has video explaining genetic basis of cancer 

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• 
Has links to Cancer Genomics Overview and Research 
 
American Cancer Society Genetics and Cancer: https://www.cancer.org/cancer/cancer-
causes/genetics.html 
 
Medical Genetics 101: http://www.ashg.org/education/medical_genetics.shtml 
 
General Support 
Genetic Counseling 
• 
National Society of Genetic Counselors: http://www.nsgc.org/page/aboutgeneticcounselors 
 
• 
Find a Cancer Genetics Clinician (NIH): https://www.cancer.gov/about-cancer/causes-
prevention/genetics/directory 
 
• 
KinTalk: http://kintalk.org/ 
 
• 
My Family Health Portrait: https://familyhistory.hhs.gov/FHH/html/index.html 
 
Cancer Therapy Evaluation Program (NIH): https://ctep.cancer.gov/default.htm 
 
My Cancer Genome: https://www.mycancergenome.org/ 
 
CancerCare: https://www.cancercare.org/ 
 
ASCO Resources (fact sheets, planning, caregiving): https://www.asco.org/practice-
guidelines/resources-patients 
 
ACS Resources (diagnoses, treatment options): https://www.cancer.org/treatment.html 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix P: HOPE-Genomics Survey Script (Via Phone or Zoom) 
 
Hello, my name is [CRA NAME] and I am a clinical research assistant with the HOPE-Genomics Team 
at City of Hope. Is there a [(Mr. Ms) PATIENT NAME] here? 
 
Hi [(Mr. Ms) PATIENT NAME], I am reaching out to you today because you recently expressed an 
interest in completing your [INSERT SURVEY NAME] over [PHONE/ZOOM]. Is now still a good time to 
meet?  
[IF NO: schedule another time to talk to patient] 
 
[IF YES] Wonderful. Before we begin, I would like to mention a few points about the survey. We 
estimate that this will take approximately [INSERT TIME VALUE] to complete together.  
The purpose of this survey is to get your feedback about your cancer care at City of Hope and what you 
understand about genomics. I am going to read the survey verbatim and record all the responses you 
provide. These responses will be kept confidential and identified only by a number. Please keep in mind 
that you are free to not answer any question in this survey, for any reason. As we go through the 
survey, please let me know if you have any questions or need clarification. This survey does include 
general questions about genetics and cancer. For these questions, please keep in mind that I cannot 
assist you selecting the correct answers. 
Do you have any questions before we begin?  
[AFTER ANSWERING ANY QUESTIONS]: Proceed to read IRB-approved survey verbatim. 
 
 
 

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Appendix Q: HOPE-Genomics Withdrawal Email Template 
 
Dear Mr./Ms./Dr. [PATIENT’S NAME],  
Thank you for letting us know about your decision to withdraw from the HOPE-Genomics 
study! We completely understand, and truly appreciate your interest in our study. 
 
To document withdrawal and protect your personal information, City of Hope requires 
you to complete the attached withdrawal form at your earliest convenience. I have 
attached the form to this email, and I will also mail you a physical copy of the form with a return 
envelope.  
You can either mail or scan the completed form back to us or schedule a time to complete the 
form with us over the telephone. Please let us know what is most convenient for you so we can 
facilitate the withdrawal process as soon as possible.  
If you have any questions about completing the withdrawal form, please email 
HOPEGenomics@coh.org, or call the Principal Investigator, Stacy W. Gray at 626-218-8662 or 
the Clinical Research Coordinator, Marilan Luong at 310-218-1539. You can also reach the 
Institutional Review Board at City of Hope by calling 626-216-2700. 
Thank you very much again for your participation! 
The HOPE-Genomics Team 
Dr. Stacy Gray, Marilan Luong, Madeline Currey, Sarah Labib, and Vanessa Lozano 
Division of Clinical Cancer Genomics 
Medical Oncology and Therapeutics Research 
Department of Population Sciences 
 
City of Hope Comprehensive Cancer Center 
1500 E. Duarte Road 
Duarte, CA 91010 
 
 
 
 
 
 

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Appendix R: Patient Survey Link Text Message Script (Baseline/Pre-study/10 day/3 month/9 
month for Intervention Arms) 
 
Dear [Insert Patient Name] 
This is the HOPE-Genomics Team from City of Hope. 
This is a reminder to complete the [Title of Survey] at your earliest convenience.  
You can access the survey by clicking this link [insert link] and entering the provided study ID: [Insert 
patient study ID number]. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix S: Setup Access to HOPE-Genomics toll – RoR + Intervention Arm Text Message 
Script  
 
Dear [Insert Patient Name] 
This is the HOPE-Genomics Team from City of Hope. 
We would like to invite you to log into and view the HOPE-Genomics before your results are ready. The 
tool contains helpful information that explains the details of genomic testing and its implications for your 
health.  
You may log into the tool by clicking the following link: https://hopegenomics.coh.org/login. 
Once you have viewed the tool, we will send you a follow-up survey. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix T: Patient Reminder to View HOPE-Genomics with Genetic Test Results Text Message 
Script  
 
Dear [Insert Patient Name] 
This is the HOPE-Genomics Team at City of Hope.  
We would like to remind you to log into the HOPE-Genomics tool to view your genetic test results.  
You may log in by clicking the following link: https://hopegenomics.coh.org/login.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix U: Text-Message Opt-in for Previously Consented Subjects - Template for Email and 
Mailer  
 
Dear [Insert Patient Name] 
This is the HOPE-Genomics Team from City of Hope.  
You are receiving this letter as a participant on the study, HOPE- Genomics Web Tool Randomized 
Clinical Trial.  
We are writing to inform you of an update to the study’s consent form. As part of this update, we have 
included an optional opt-in for patients who would like to receive text message reminders about study 
related tasks and to receive survey links directly to their mobile. Messages will not contain any 
information regarding course of care at City of Hope. Standard message and data rates may apply 
based on your mobile carrier.   
Signing up for text message reminders is optional. Your decision will not risk and/or change your 
participation on this study.  
If you would like to receive text message reminders, please email us at hopegenomics@coh.org. A 
member of the HOPE-Genomics Team will reach out to you by phone to provide more information.   
Thank you for your willingness to participate in our research study involving new ways to teach patients 
about cancer and genetics!  
 
The HOPE-Genomics Team 
Dr. Stacy Gray, Marilan Luong, Madeline Currey, Sarah Labib, and Vanessa Lozano 
Division of Clinical Cancer Genomics 
Medical Oncology and Therapeutics Research 
Department of Population Sciences 
 
City of Hope Comprehensive Cancer Center 
1500 E. Duarte Road 
Duarte, CA 91010 
  
 
 
 

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