Video Intervention to Address Pre-Test Patient Education for Tumor Genomic Testing
Phase: NA
Conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Lung Carcinoma, Metastatic Malignant Solid Neoplasm, Prognostic Stage IV Breast Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Sponsor: Ohio State University Comprehensive Cancer Center

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Study Title: Video Intervention to Address Pre-Test 
Patient Education for Tumor Genomic Testing 
 
 
Local Trial ID: OSU-21313 
Clinicaltrials.gov Identifier: NCT05215769 
IRB approval date: 12 August 2023 
 
 
 

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Title: Video Intervention to Address Pre-Test Patient Education for Tumor Genomic Testing 
 
 
Study team: 
 
Co-Principal Investigators: 
Daniel Stover, MD 
Assistant Professor 
Medical Oncology 
 
Leigha Senter-Jamieson, MS, CGC 
Associate Professor 
Human Genetics  
 
Co-Investigators: 
Amanda Toland, PhD 
Professor 
Cancer Biology and Genetics 
 
Carolyn Presley, MD 
Assistant Professor 
Medical Oncology 
 
Shelly Hovick 
Assistant Professor 
School of Communication 
 
Wei Lai, PhD 
Assistant Professor 
Center for Biostatistics 
 
James Kim, MD 
Medical Oncology 
Mercy Health Youngstown, OH 
 
Michael J. Bishop, MS, MD 
Radiation Oncology 
Mercy Health St. Rita’s Cancer Center Lima, OH 
 
William Irvin, MD 
Director of Clinical Research 
Bon Secours Cancer Institute, Richmond, VA 
 
 
Key Personnel: 
Deloris Veney 
Clinical Research Assistant 
Medical Oncology 
 
Clarissa Alford 
Clinical Research Coordinator 
Mercy Health – St. Rita’s Medical Center  
 
Anne Caramella 
Research Manager 
Bon Secours Cancer Institute - St. Francis Medical Center 

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Kimberly Garnett 
Clinical Research Nurse 
Bon Secours Cancer Institute - St. Francis Medical Center 
 
Kristin Bodine 
Clinical Research Nurse 
Bon Secours Cancer Institute - St. Francis Medical Center 
 
Mary Williams 
Clinical Research Nurse 
Bon Secours Cancer Institute - St. Francis Medical Center 
 
 
Cathy Engartner 
Clinical Research Coordinator 
Mercy Health – St. Elizabeth’s Youngstown 
 
Jo Wilms 
Clinical Research Coordinator 
Mercy Health – St. Elizabeth’s Youngstown 
 
 
 
Sponsor:  
National Cancer Institute (1R21CA259985-01) 
Healthy State Alliance (Cohort 4 – Bon Secours Mercy Community sites) 
 
 
 

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Objectives: 
The primary goal of this project is to evaluate a series of videos to be used for pre-test education of patients who 
undergo tumor genomic testing (TGT) as part of their clinical care.  We aim to test the impact of a concise, animated 
educational video to be used as a supplement to patient-provider discussion on patient understanding of TGT, 
including benefits, limitations, and possibility of incidental findings when doing TGT.  We will compare results in 
four patient cohorts: 1) Ohio state University Comprehensive Cancer Center (OSUCCC) metastatic breast cancer 
patients; 2) OSUCCC lung cancer patients; 3) OSUCCC cancer patients of unspecified type; Bon Secours Mercy 
Health (BSMH) community cancer center cancer patients of unspecified type. The video addresses critical patient-
identified and literature-reported education gaps prior to TGT.  
 
Background and Rationale: 
 
Somatic (tumor) next-generation sequencing (TGT) and cancer care 
 
TGT has become increasingly adopted as part of standard cancer care for many cancers,1 raising important ethical 
challenges regarding its use including uncertainty of applicability of results, incidental germline findings, and 
disparities around tumor genomic testing options.2,3 It is critical to address these challenges now given the growing 
reliance on tumor NGS results for treatment-related decision-making in an increasingly large population of patients 
with cancer. 
 
Patient education and tumor genomic testing 
 
Professional guidelines state that treating oncologists should discuss with patients prior to testing the possibility of 
incidental germline findings and disease-specific limitations in clinical utility and interpretation of somatic (tumor) 
next generation sequencing (NGS) results.5 However, oncologists have varied understanding of genetics and time 
limitations make it challenging for providers to adequately inform their patients about tumor NGS within the context 
of routine clinical care.  As a result, pre-test education is often incomplete and has significant variability across 
providers resulting in inequitable care.   
 
These challenges have been echoed by professional organizations and were highlighted by a policy statement 
released by the American Society of Clinical Oncology (ASCO),5 which notes: “1) Oncology providers should 
communicate the potential for incidental/secondary germline information…before conducting somatic mutation 
profiling and should review potential benefits, limitations, and risks before testing; 2) Providers should carefully 
ascertain patient preferences regarding the receipt of germline information...This may require referral for additional 
counseling to help the patient clarify preferences; 3) ASCO supports research to determine how to best deliver 
pretest education, support patient preferences, and understand outcomes of providing incidental/secondary germline 
information with somatic testing.”  
 
Despite professional organization support, evidence suggests that national guidelines are not widely followed.  We 
previously surveyed medical oncologists at Ohio State (unpublished), with response rate 77.5% (31/40). Providers 
frequently order tumor NGS: 67.7% obtain tumor NGS on >25% of patients. Providers frequently discuss tumor 
NGS benefits (87.1% counsel all patients on benefits), yet less frequently discuss limitations (58.0%). The potential 
of incidental germline findings is rarely discussed: <20% of providers discussed with all and 25.8% discussed with 
none of their patients. One possible explanation: 61.3% of providers feel they do not have enough time in a routine 
visit to provide adequate patient counseling. These data reveal marked gaps in patient education prior to tumor NGS 
among providers for the proposed study population.  
   
Additionally, patients’ understanding of genomics remains limited, particularly lower income and minority patients, 
and most patients are not informed regarding potential incidental germline findings.6 This is not a trivial problem as 
incidental germline findings are surprisingly common. Among 1040 patients undergoing MSK-IMPACT tumor-
normal NGS assay, 182 had actionable cancer susceptibility germline mutations, including 101 patients who would 
not have had these mutations detected using clinical guidelines.7 In another study of 1000 patients of all cancer 
types, 2.3% patients had previously unrecognized pathogenic germline mutations in 19 cancer-related genes.6 In our 
recent prospective decision analysis study,8 14/100 patients had alterations identified in BRCA1 (n=4), BRCA2 
(n=8), or PALB2 (n=2). Of the patients with these alterations, 6/14 (42.8%) did not have prior knowledge of 
germline alteration. At our center, we confirm prior data of incidental germline findings in ~5% of patients 

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undergoing tumor NGS, reinforcing the importance of pre-test education regarding germline alterations prior to 
tumor NGS. 
 
Our prior data also show that results of TGT can impact patients’ outlook regarding likelihood of treatment success.  
In a published study that enrolled 100 participants with MBC, we found that patients whose treatment did not 
change based on tumor NGS had a significant decrease in confidence of treatment success (p=0.001).8 Patients were 
overly optimistic: almost half believed tumor NGS would guide therapy while only 11.5% switched therapy based 
on tumor NGS,8 similar to prior work.9,10 The validated Trust in Physician/Provider Scale (TPS) – to be used in this 
study – was administered successfully, and notably, TPS did not significantly correlate with depression, anxiety, or 
self-efficacy, suggesting that this metric is not likely to be confounded by other patient psychological features. We 
demonstrate capacity to successfully complete prospective tumor NGS in the context of a clinical trial with 
completion multiple validated survey instruments.  
 
Video interventions to address gaps in patient education around genetic/genomic testing 
 
Effective communication is critical for patient-centered care but is complicated by low health literacy in the general 
population.11 Genetic information in particular presents a challenge given complexity of the subject matter and gaps 
in understanding for patients12 and providers.13 In a previous study, we developed a 2-minute animated video to be 
used by patients to communicate their own germline BRCA mutation result to at-risk relatives (video available at 
14). We studied effectiveness of video message in a healthy unselected cohort to mimic the scenario of a relative 
(who was previously unaware of the family’s genetic testing) receiving this information via video. Of 373 
participants who viewed the video and completed pre-/post-viewing questionnaires, we saw a significant increase in 
video content-specific recall (p<0.0001) in all demographic categories and a positive association between 
intolerance for uncertainty and intent to pursue action related to cascade genetic testing (p<.05).15 
 
The implementation of a video intervention that aids in educating patients about the utility and possible outcomes of 
tumor genetic testing in accordance with professional organization recommendations is feasible. With MSK-
IMPACT, patients who desire germline DNA results receive pre-test genetic counseling via an IRB-approved video. 
(Hyman, 2015) Recently presented at ASCO 2020, Bradbury et al. show that a web-based video intervention 
increased patient understanding but did not significantly reduce anxiety, depression, or cancer-specific distress. 
(Bradbury, 2020)  
 
Study communication aid: A video to address pre-test patient education for tumor genomic testing 
 
To address ongoing gaps, we are developing a video intervention to address pre-test patient education for tumor 
genomic testing, accomplished through a previous protocol, “Assessment of and addressing the needs of diverse 
patient populations undergoing tumor next generation sequencing (NGS) as part of oncology care,” (OSU IRB # 
2021B0077). Through a series of focus groups or interview discussions, we identified patient-reported education 
gaps and concerns prior to tumor NGS testing by engaging diverse populations (sex, gender, race, ethnicity (if 
provided), age, insurance status/sociodemographic, cancer type).   
 
Based on focus group data, ASCO-recommendations for pre-test education, and expert input from Cancer Genetics 
and Communications faculty, a concise animated video using plain language is in process, designed by OSU 
investigators and produced by Mills James Productions..  This video will be adapted into three separate educational 
videos for distinct patient populations: 1. Metastatic breast cancer-specific; 2. lung cancer-specific and 3. Tumor 
agnostic for delivery prior to tumor NGS. The rationale for the inclusion of three separate cohorts is to make 
possible a comparison of results between the groups.  Clinically, the utility of tumor NGS in the breast cancer 
population and the lung cancer population differs, with a greater number of genomic alterations identifying potential 
therapies in lung cancer, and it’s possible that the results in these cohorts will diverge.  The information contained in 
the videos is identical with the exception of two sentences within which breast- and lung-specific information about 
the likelihood of treatment change based on tumor NGS is given.  It’s possible that these targeted statements will 
have no impact on the study outcomes, which is why we will test a tumor agnostic video in an unselected cancer 
population.  
 
Objectives: 
 

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Primary Objective: To assess change in patient knowledge about tumor NGS following exposure to the video. 
Hypothesis: Exposure to a brief educational video will increase patient knowledge about tumor NGS. 
 
Secondary Objectives:  
Secondary objectives include to assess changes following exposure to the video, including: 
1) Genomic knowledge via the validated 10 true/false question survey (% correct out of 10);  
2) 11-item Trust in Physician Survey (TPS) as a single TPS score; 
3) Comparison of results in distinct patient cohorts: 1) Metastatic breast cancer; 2) lung cancer; 3) cancer of 
unspecified type; 4) cancer of unspecified type at community cancer centers 
Hypotheses: Change in patient understanding about tumor NGS and trust in provider will vary based on 
baseline/demographic characteristics but also cohort/cancer type. 
 
Exploratory Objective (only at patients enrolled at OSUCCC): Assess whether therapies prescribed as a result of 
tumor NGS achieved clinically favorable result through chart review. 
 
 
Research Design: 
 
Study Population 
 
In this proposal, we will use a single IRB protocol to prospectively enroll patients with cancer undergoing clinical 
tumor NGS as part of standard-of-care disease management in fourclinical cohorts: Cohort 1. Metastatic breast 
cancer (MBC; n=50). Cohort 2: lung cancer (LC; n=50); Cohort 3. cancer patients of any tumor type (OC; n=50); 
Cohort 4, cancer patients of any tumor type at Bon Secours Mercy Health community cancer sites (BSMH, n=50). 
 
At Ohio State, we manage >700 LC and >500 MBC patients annually, demonstrating sufficient patient volume to 
accrue. After enrollment but before video viewing (T1), a participant will complete the first study questionnaire, 
which assesses personal characteristics, tumor NGS-specific knowledge, genomic literacy/knowledge, tolerance for 
uncertainty, patient-provider trust, and attitudes about the information received and testing to be performed. 
Immediately following video viewing, participants will complete a post-counseling questionnaire (T2), which re-
assesses the same knowledge components, patient-provider trust, and attitudes about the information received and 
testing to be performed. Participants will be asked to complete a post-genomic testing questionnaire (T3) after their 
tumor NGS result is available.  When possible, this will occur during the clinic visit at which this is discussed and if 
not possible, the participant will be contacted after this clinical encounter takes place. T3 questionnaire will mirror 
the T2 questionnaire.  
 
Eligibility criteria 
 
Inclusion Criteria. Patients must have biopsy-confirmed cancer, be ≥18 years of age, and be undergoing clinical 
tumor or circulating tumor DNA NGS. This will be gender- and race-inclusive: we will include all races and 
ethnicities and both women and men, including male breast cancer patients (~1% of all breast cancers16). Exclusion 
Criteria: We will have both English- and Spanish video versions but in this initial study will exclude patients who 
are not English- or Spanish-speaking. 
 
Study procedures 
 
Eligible participants may be identified for invitation to participate in a video intervention session by study personnel, 
through provider nomination, or self-nomination (see flyer for oncology waiting areas).  Study personnel will review 
clinic schedules on a weekly basis and maintain an accrual log to facilitate identification of eligible patients. Once 
eligible patients are identified and the study is introduced to them by their physician or his/her designee (e.g. nurse), 
study personnel will discuss the risks and benefits of the study with the subject. Recruitment will take place during 
the patient’s regular clinic visit after patient has been informed by their provider that tumor NGS has been 
recommended. Once contact is established, study personnel will ask questions to assess eligibility. 
 
 
Informed Consent Process 

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Subjects will have the option to complete the informed consent process on a secure electronic tablet or on paper. 
During the in-person consent process, patients will be consented by a member of the key study personnel who will 
oversee the use of the tablet and the completion of the live electronic signatures.  Alternatively, a member of the key 
study personnel may oversee the completion of the paper format consent. 
 
Electronic consenting 
The participant consent encounter will be conducted using a REDCap-based electronic consent form.  The consent 
form has been developed in REDCap, a secure, web-based, HIPAA-compliant, data collection platform with a user 
management system allowing project owners to grant and control varying levels of access to data collection 
instruments and data (e.g. read only, de-identified-only data views) for other users.   
 
Subjects’ signatures (and initials) may be obtained using a computer mouse or their finger in the appropriate fields 
on the consent form(s).  The signature will also include the subject’s typed/printed name and the date (and time 
where required).  Upon completion of the consent, patients will receive a copy of the consent documents via:  
• 
A hard copy of the completed consent form(s) that has been printed or copied in clinic 
• 
An emailed copy of the completed consent form(s) which is sent to the subject’s chosen email address 
 
Survey measures 
 
We will collect individual characteristics at T1 and four validated survey approaches at T1, T2, and T3.  Surveys 
will be administered electronically in clinic on iPads reserved for the study.  If a participant requires paper 
questionnaires or to complete the questionnaires outside of the clinical setting, accommodations will be made.  
 
Incentives 
 
All respondents to surveys will be offered a $10 gift card upon completion of each online survey.  In total, each 
participant can receive up to $30 in incentive gift cards. 
 
Data Analysis 
 
Our primary endpoint will be message-specific knowledge/recall accuracy, measured as number correct out of 10 
questions. Based on preliminary data, with each cohort of 50 patients, we will have 90% power to detect an effect 
size of 0.47 in change of recall accuracy from pre- (immediately prior) to post- (immediately after) video 
intervention, using a two-sided Wilcoxon signed-rank test with alpha of 0.05. Secondary endpoints include change 
in patient 1) genomic knowledge via the validated 10 true/false question survey (% correct out of 10)22; 2) 11-item 
Trust in Physician Survey (TPS) as a single TPS score.21 All secondary outcomes will be summarized using 
descriptive statistics and compared pre-/post-video using Wilcoxon signed-rank test. For comparisons of MBC and 
LC, endpoints will include 1) baseline and pre-/post-video intervention change in genomic knowledge/understanding 
in MBC versus LC patients; 2) baseline and pre-/post-video intervention change in trust in physician/provider. The 
baseline and the change from pre- to post-video intervention in the secondary outcomes will be compared between 
MBC and LC patients using Wilcoxon rank sum test. 
 
Sample Size Justification 
 
Power calculations were based on the primary outcome of message-specific knowledge/recall accuracy.  Assuming 
an effect size of 0.47 in change of recall accuracy from pre- (immediately prior) to post- (immediately after) video 
intervention, using a two-sided Wilcoxon signed-rank test with alpha of 0.05, then a sample size of 50 patients per 
group has 90% power to detect a difference. We will enroll a maximum of 75 participants per cohort (total 
maximum 300 participants) to allow for participant drop out. In the context of COVID, there is potential that T3 
surveys response rate will be impacted, thus expanded maximum enrollment facilitates full cohorts for all 
timepoints. 
 
Data Safety and Monitoring Plan 
 
There is no data safety monitoring board for this minimal risk study.  RedCap will assign a code number to each 
participant for the purposes of linking their data across surveys.   

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This study will utilize REDCap (Research Electronic Data Capture), a software toolset and workflow methodology 
for electronic collection and management of clinical and research data, to collect and store data. The Ohio State 
Center for Clinical and Translational Science (CCTS) Research Informatics Services will be used as a central 
location for data processing and management. REDCap provides a secure, web-based application that provides an 
intuitive data manipulation interface, custom reporting capabilities, audit trail functionality, real-time data 
monitoring/querying of participant records, and variations of data exporting/importing. REDCap is hosted by 
OSUWMC IT in the Ackerman Datacenter (640 Ackerman Road; Room 345) 
 
REDCap instance is located on an internal OSUWMC network. Remote access to this network can be obtained over 
an encrypted VPN tunnel (AnyConnect). This VPN uses Protocol: DTLS and Cipher: RSA_AES_128_SHA1. 
Background checks are performed on all staff that are on the network or obtaining VPN access.  Guest User 
accounts will be provided for the key personnel of BSMH that will be administering the survey at community cancer 
centers. 
 
 
We will store any exported data on a secure, password protected server in the Division of Human Genetics. For 
patients enrolled at OSUCCC, the personally identifiable private information involved in the research includes 
patient name, medical record number, sex, cancer diagnosis, diagnostic tests ordered and the dates of such tests, 
treatment and outcome for 5 years post tumor genomic test result reporting.  IHIS patient charts will be the source of 
all information utilized. 
 
For patients enrolled at BSMH, the personally identifiable private health information, PHI, involved in the 
researchincludes patient name, MRN,  cancer diagnosis, the specific NGS test ordered because it varies across 
cancer types, date of its order, as well as information regarding their next appointment: day, date, time and location 
to facilitate the research encounter. This information will be collected by the study personnel per a partial HIPPA 
waiver as part of screening procedures. PHI will be maintained in Microsoft 365’s Onedrive. Paper documentation 
regarding research participation will be stored in locked cabinets within locked offices. 
Potential Risks and Benefits 
 
While some participants may not view this as a benefit, some participants may benefit from improved understanding 
of tumor genomic testing which may be valuable to certain participants.  They could help society through 
improvements to cancer care based on results of the study.   
 
There are no perceived physical or health risks related to participation in this study. However, there is a theoretical 
risk that topics that may arise from the questionnaires or video viewing could cause an emotional response in 
recipients, but this is not beyond what is expected in everyday life as it pertains to tumor genomic testing.  There is a 
small risk of release of medical data that is not intended.  This could affect insurability or employability.  
 
 
 
 

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