Reducing Racial Disparities in Cancer Care With PINPOINT (Promoting INformed Approaches in Precision Oncology and ImmuNoTherapy)
Phase: NA
Conditions: Clinical Trials, Immunotherapy
Sponsor: Rutgers, The State University of New Jersey

 
 
 
 
 
 
Reducing Racial Disparities in Cancer Care With PINPOINT (Promoting INformed 
Approaches in Precision Oncology and ImmuNoTherapy) 
NCT05034289 
July 7th, 2025 

 
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INTERVENTIONAL 
RESEARCH PROTOCOL TEMPLATE 
(HRP-503a) 
 
STUDY INFORMATION 
 
Title of Project: 
Reducing Racial Disparities in Cancer Care with PINPOINT (Promoting Informed 
approaches in Precision Oncology and ImmuNoTherapy)  
 
Principal Investigator Name 
Anita Y. Kinney, PhD, RN 
 
Principal Investigator Div. & Dept. 
School of Public Health, Rutgers University  
Department of Epidemiology, Rutgers University  
Center for Cancer Health Disparities, School of Public Health Cancer 
Health Equity, Cancer Institute of New Jersey   
 
Principal Investigator Contact Info:  
anita.kinney@rutgers.edu 
195 Little Albany Street  
New Brunswick, NJ 08903-1384 
732-235-8871 
 
Protocol Version and Date: V8 07.08.2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table of Contents 
Skip To Section: Hold CTRL + Click (Below) To Follow Link in Blue 
 
1.0 
Research Design 
1.1 
Purpose/Specific Aims 
1.2 
Research Significance 
1.3 
Research Design and Methods 
1.4 
Preliminary Data 
1.5 
Sample Size Justification 
1.6 
Study Variables 
1.7 
Drugs/Devices/Biologics 
1.8 
Specimen Collection 
1.9 
Data Collection 
1.10 
Timetable/Schedule of Events 
2.0 
Project Management 
2.1 
Research Staff and Qualifications 
2.2 
Research Staff Training 
2.3 
Resources Available 
2.4 
Research Sites 
3.0 
Multi-Center Research 
4.0 
Subject Considerations 
4.1 
Subject Selection and Enrollment Considerations 
4.2 
Secondary Subjects 
4.3 
Number of Subjects 
4.4 
Consent Procedures 
4.5 
Special Consent Populations 
4.6 
Economic Burden and/or Compensation For Subjects 
4.7 
Risks of Harm/Potential for Benefits to Subjects to Subjects 
5.0 
Special Considerations 
5.1 
Health Insurance Portability and Accountability Act (HIPAA) 
5.2 
Family Educational Rights and Privacy Act (FERPA) 
5.3 
Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
5.4 
General Data Protection Regulation (GDPR) 
5.5 
 NJ Access to Medical Research Act (Surrogate Consent)  
6.0 
Data Management Plan 
6.1 
Data Analysis 
6.2 
Data Security 
6.3 
Data Safety And Monitoring 
6.4 
Reporting Results 
 
6.5 
Secondary Use of the Data 
7.0 
Research Repositories – Specimens and/or Data 

 
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8.0 
Approvals/Authorizations 
9.0 
Bibliography 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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1.0 Research Design 
 
1.1 Purpose/Specific Aims 
This community-engaged study develops a model intervention for increasing awareness, facilitating 
informed and shared decision making, and improving access to clinical trials and recommended cancer 
treatments in traditionally underserved populations.  
A.  Objectives  
Employ a community-engaged approach, including a Community Advisory Board and key informant 
interviews, to a) assess knowledge, attitudes, beliefs, and sociocultural, clinical, and system-level 
factors (e.g. barriers) that may explain disparities in decisions about use of precision oncology in 
Black cancer patients; b) Utilize this information to guide the iterative development and pilot testing 
of an innovative, patient-centered and culturally tailored internet-based education and decision 
support intervention, “Promoting Informed approaches in Precision Oncology and ImmuNoTherapy 
(PINPOINT),” to reduce racial disparities in access to, and use of, guideline-based therapy and 
potentially save lives.  
B.  Hypotheses / Research Question(s) 
We hypothesize that by the end of this project we will have developed a culturally acceptable 
PINPOINT intervention. We hypothesize that 80% of the pilot testing participants will report that the 
intervention prototype is acceptable and usable as defined by a mean acceptability score of 4 or 
higher and a mean feasibility score of 4 or higher. We hypothesize that 70% of the pilot testing 
participants will answer at least 70% of the knowledge questions correctly. We hypothesize that 
70% of pilot testing participants will report feeling empowered to talk to their physician about 
precision oncology treatments, clinical trials, and tumor testing. The study findings will prepare the 
research team to conduct a randomized controlled trial for rigorous efficacy testing.  
1.2 Research Significance 
Racial disparities in cancer are well established, and despite efforts to ameliorate them, Black men and 
women continue to have lower cancer survival rates, lower rates of accessing quality and timely care 
compared to Whites.1-6 A higher proportion of Blacks are diagnosed with more advanced stages of 
disease compared to Whites,1 yet even when the disease is found early, with the highest potential to 
be cured, delays in treatment can lead to poorer outcomes. The reasons for this unequal burden appear 
to be due to a complex interaction between biological, environmental, social, system-level, and political 
factors. Racial differences in access to innovative cancer care technologies, particularly precision 
oncology may further widen the disparities gap.7-12 Many challenges unique to racial disparities in 
precision oncology are emerging, and important questions need to be explored in order to develop 
effective solutions to promoting cancer health equity. 
Precision oncology uses molecular profiling to identify and target alterations in an individual’s tumor for 
improved cancer outcomes.13 Molecularly targeted therapies, including immunotherapy, have 
revolutionized cancer care. Immunotherapy identifies and disrupts ways in which tumors evade the 
body’s natural defenses, thereby activating the immune system to attack cancer cells.14 For example, 
immune checkpoint inhibitors (ICIs) have been shown to induce clinically significant and sometimes 
long-lasting responses in many cancers.15-17  ICIs are drugs that block immune checkpoints. By 
blocking these checkpoints, ICIs allow immune cells to respond more strongly to cancer.  Monoclonal 
antibodies, another type of immune therapy, are immune system proteins developed in the lab that are 
designed to bind to specific targets on cancer cells.  Treatment vaccines are used to treat cancer by 
boosting one’s immune system’s response to cancer cells.   Immune system modulators enhance the 

 
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body’s immune response against cancer by either affecting specific parts of the immune system or 
affect the immune system more globally. 
Immune therapy, either alone or in combination with chemotherapy, are now part of the standard care 
for cancers such as breast, bladder, cervical, colorectal, head and neck, liver, lung, renal cell, skin, 
stomach, other solid tumors and non-Hodgkin’s lymphoma. Despite the potential of immunotherapy to 
improve outcomes, Blacks receive less guideline-based care, including immunotherapy.2,11,12,18-20 
Because each patient responds differently to precision oncology treatments, it is crucial to pinpoint 
which patients would respond best to each treatment and match them appropriately. Yet Blacks are 
less likely to receive tumor sequencing than Whites8,9,21,22 and are therefore less likely to be matched 
to the optimal treatment. Furthermore, Blacks are consistently and drastically underrepresented in 
clinical trials, and the efficacy and toxicity of immune therapy among minority populations are not well 
studied.23 For example, clinical trials of ICIs for prostate cancer either do not report the racial 
composition of the sample or have an extremely low proportion of African Americans, ranging from 
05%, despite the high proportion of Blacks who develop prostate cancer.24-28 With so few Blacks 
participating in clinical trials, subgroup analyses are impractical, and therefore immune therapy 
response is understudied in this population. 
Closing the disparities gap will require strategies to promote awareness, shared and informed decision-
making, and empowerment for Black cancer patients to discuss tumor testing, innovative treatment 
options, and clinical trials.  
1.3 Research Design and Methods 
This project encompasses the meticulous development, feedback, and pilot testing of the PINPOINT 
web-based intervention designed to improve preparation for decisions about precision oncology. The 
developmental process will begin with the collection of qualitative data through Community Advisory 
Board input, continue with in-depth interviews from key stakeholders to enable prototype refinement, 
and end with pilot testing of the intervention. The decision aid is designed to: a) improve knowledge 
and awareness about clinical trials and precision oncology among Black cancer patients and families; 
b) foster informed/shared decision-making regarding guideline-based precision therapies; and c) 
promote favorable attitudes about clinical trials participation in an underrepresented population to 
speed the translation of research findings into practice and contribute to a needed evidence base of 
racially diverse precision oncology trials. Once completed, this study will have developed and refined 
an intervention that will be prepared for rigorous efficacy testing, followed by broad dissemination to 
Black cancer patients and families across the country.  
A. Research Procedures 
Community Advisory Board 
We will convene a study-specific Community Advisory Board (CAB) comprised of Black patients 
and advocates, some of whom have served on our Cancer Community Action Board and Precision 
Oncology Workgroup. We will also include Black oncology healthcare providers and administrators 
for their perspectives on implementation. The CAB will have 8-10 members and will meet twice per 
year virtually. The CAB will review an initial prototype of the intervention and provide their input on 
the cultural relevance, design, implementation of the PINPOINT intervention, and interpretation and 
dissemination of findings, as well as assist with recruitment for key informant interviews and 
dissemination at the completion of the project period. The CAB will also help create a key informant 
interview guide, which will probe issues related to: a) attitudes, beliefs, and sociocultural, clinical, 
provider-level and system-level factors that may explain disparities in decisions about use of 
immunotherapy and clinical trial enrollment in Black cancer patients and b) information needs, 
preferences, and strategies for addressing barriers via an effective culturally relevant intervention. 
The CAB will also provide guidance on study implementation, interpretation of findings, 

 
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dissemination of results, and next steps. CAB members will be offered a stipend of $250-$400 per 
meeting depending on their time commitment and the length of the meeting. Once feedback is 
collected from the CAB, we will continue forward with the study.  
Key Informant Interviews 
We will conduct  48 key informant interviews to refine the culturally tailored web intervention. Key 
informants will comprise three diverse stakeholder groups: 1) Black cancer patients; 2) relatives of 
Black cancer patients; and 3) providers/staff (oncologists, nurses, social workers, patient navigators 
and financial counselors in oncology settings) to yield a comprehensive picture of multilevel factors 
impacting decision-making and receipt of innovative cancer treatments. In collaboration with the 
CAB, we will use purposive, snowball sampling to identify and select a sample of  48 participants. 
These informants will be selected for their knowledge and ability to speak about their needs, 
preferences, experiences and the factors that impact tumor testing, guideline-based 
immunotherapy treatment, and clinical trials participation among Blacks from their perspectives as 
patients, relatives, and providers (including providers from community health sites that treat a large 
number of Black patients). Participants will be selected because of who they are and what they 
know, rather than by chance. All participants must be over 18, read and speak English fluently, be 
able to provide informed consent, and complete assigned study surveys and interviews. Patients 
must have been diagnosed with cancer or currently living with cancer (including metastatic cancer) 
and self-identify as Black or African American. Relatives must be the spouse, blood relative, or 
caregiver of a cancer patient who identifies as Black or African American. Table 1 reflects key 
informant eligibility criteria. We will select up to 20 participants representing each segment (patient, 
relative, and provider). We will work with the CAB to identify and contact potential informants 
through their social and professional networks. In addition, a trained staff member will conduct chart 
reviews of electronic medical records (EMR) at Rutgers Cancer Institute for patients who may be 
eligible. Additional recruitment will occur through community outreach, Rutgers listservs, and 
patient portals. 
Table 1. Key Informant Eligibility Criteria 
Patient Criteria 
Relative Criteria 
Provider Criteria 
Age 18 and older 
Age 18 and older 
Age 18 and older 
Self-identify as Black or 
African American 
Spouse, blood relative, or 
caregiver of a cancer patient 
who identifies as Black or 
African American 
Physician, nurse, social 
worker, patient navigator, or 
financial counselor 
Able to read and speak  
English fluently 
  
Able to read and speak 
English fluently 
Able to read and speak 
English fluently 
Able to provide  
informed consent 
  
Able to provide informed 
consent 
Able to provide informed 
consent 
Able to complete 1 survey 
and an in-depth interview 
Able to complete 1 survey 
and an in-depth interview 
Able to complete 1 survey 
and an in-depth interview 

 
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Diagnosed with or currently 
living with cancer, including  
metastatic cancer 
 
Work in oncology setting at 
participating clinical site 
Once a list of potential participants is developed, the Program Assistant will make initial contact via 
email, letter, and/or telephone to invite them to participate in the study and schedule a telephone 
interview. Participants may also be recruited face-to-face in the clinic. Interested individuals will be 
further screened for eligibility by telephone. Study staff will provide, mail, or email the informed 
consent document to those who screen eligible and review the elements of consent in-person or 
by telephone, answering questions and ensuring complete comprehension. After reviewing the 
consent document, participants will provide their informed consent via REDCap with an electronic 
signature. Participants will then complete a baseline survey (online via REDCap, by phone, or on 
paper by mail) and staff will schedule the 1.5-hour in-depth interview. For patients, interviews will 
take place prior to the scheduled surgical oncology consultation. On the baseline surveys, 
participants will report demographic variables as well as answer questions assessing knowledge 
and attitudes toward tumor testing, precision oncology, immunotherapy, and clinical trials. 
We anticipate that up to 20 interviews per segment will be conducted to reach thematic saturation.29 
We will conduct a first wave of up to 10 interviews per segment as initial interviews and as referral 
sources for a second wave of up to 10 confirming/disconfirming interviews.30,31 A strength of this 
design is that the research evolves over time, maximizing the ability to identify additional key 
stakeholders from whom to obtain data.32-34 Interviews will be conducted by a trained interviewer. 
Probes/questions will explore experiences and preferences focused on ODSF and SDM Model 
constructs such as: 1) beliefs and attitudes; 2) patient and family values/preferences for cancer 
treatment, including immunotherapy, 3) issues regarding consideration and understanding of 
treatment options, shared and informed decision-making, 4) how to enhance preparation for 
discussion about precision oncology with the oncologist (e.g., example patient video, patient 
questions and concerns that can be printed and/or sent to oncologist as text message or email in 
advance of appointment); 5) informational needs, 6) information seeking, and 7) barriers and 
facilitators. During the interview, participants will also view a prototype of the PINPOINT 
intervention, providing feedback as they explore the website and its features. The interviewer will 
take observational field notes regarding the participants’ reactions, and usage data will be collected 
using an app.  
Patients and relatives participating as key informants will be offered a $50 gift card incentive 
following completion of the interview. Institutional policies do not allow providers to receive this type 
of incentive payment. 
Prototype Development 
The intervention will be guided by best practices in health communication research and the 
International Decision Aid Standards Collaboration,35 including balanced tailored information about 
treatment options, sufficient information to help ensure patients are knowledgeable about treatment 
options, and facts about treatments (e.g., mode of delivery, frequency, potential financial concerns, 
logistical issues, side effects, outcomes and probabilities, personal values related to options, and 
guidance in steps for communication and shared decision-making to match decisions with personal 
values). Findings obtained from CAB meetings, interviews, and surveys will be used to the inform 
production of a PINPOINT prototype. From the team’s and others’ experience (including patients), 
investigators determined that 8-10 minutes is the optimal dosage acceptable to patients that is 
needed to facilitate provider communication and informed and shared decision-making without 
losing engagement. Testimonials and techniques such as “drag and drop,” “sliders,” “hover 
features,” and textboxes will maximize interactive opportunities and engagement. These 

 
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procedures have been effectively used to develop the research team’s previous web 
interventions.36-39 Programming of the intervention will be incorporated into HTML to ensure 
functionality on mobile devices (e.g., tablets and cell phones), browsers, and computers for 
maximum flexibility and to provide small segments of relevant information. Web tools will be 
integrated into the intervention’s website. The design will be grounded in best practice health 
communication principles of user centered design (UCD), learner centered design (LCD), and the 
process of analysis, design, development, implementation, and evaluation (ADDIE).40,41 In concert 
with the research team, Oxford Communications will develop and maintain the website; the group 
has prior experience on the team’s projects. 
Educational Website Pilot Testing 
Following the in-depth interviews and initial modifications, we will pilot test the prototype with 33 
newly diagnosed Black cancer patients. Clinical and demographic data, including contact 
information, cancer diagnosis, current and previous treatment, and other variables determining 
eligibility for immunotherapy will be abstracted from EMR by HIPAA-trained staff. See Table 2 for 
Pilot Testing eligibility criteria. Participants will be recruited from Rutgers Cancer Institute  
including RWJBH community oncology sites and CINJ, Newark, using the RWJBH Electronic 
Medical Record (EMR) database, EPIC. These participants will not participate in the key 
informant interviews, must speak and read English, and must be able to provide informed 
consent. Potentially eligible participants will be sent a letter inviting them to participate in the 
study. Research staff will contact individuals who do not opt out within two weeks, explain the 
study and screen for eligibility. Eligible and interested participants will complete an online 
informed consent via REDCap and then will be emailed a link to a pre-intervention survey that will 
assess demographic variables and baseline knowledge and attitudes. This survey may be 
completed any time between informed consent and immediately before the start of the pilot 
testing session.  
 
Table 2. Pilot Testing Eligibility Criteria 
 
 
 
Patient Criteria 
Age 18 and older 
Self-identify as Black or African American 
Able to read and speak English fluently 
Able to provide informed  consent 
Able to complete 2 surveys and an in-depth interview 
Did not participate as a key  informant 
Newly diagnosed with a solid  tumor cancer, (Stage I-IV) 
Have not yet consulted with an oncologist regarding treatment options  

 
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For individuals who do not have internet access, study staff will offer to go to the participant’s home and 
provide a hotspot and laptop in order to view the intervention.   
Patients will complete a follow-up survey after their appointment with their treating oncologist. Patient 
follow-up surveys can be completed online, over the phone, or on paper by mail, depending on 
participant preference. These surveys will assess post-interview knowledge and attitudes toward tumor 
testing, precision oncology, immunotherapy, and clinical trials. Staff will call participants to confirm that 
their appointment was completed prior to sending the follow-up survey. On the follow-up survey, 
patients will be asked about their attitudes, knowledge, and interactions with their provider. A $50 gift 
card incentive will be offered upon completion of each survey (baseline and follow-up survey). 
Participants will be required to complete both surveys and view each main section of the educational 
website (About, Personalized Cancer Treatment, Clinical Trials, and Resources) to receive an 
additional $50. If participants complete all study materials online and within 1 week of receiving them, 
they will receive an additional $25 for a potential total incentive of $175.  
B. Data Points 
This is a formative research study with the goal of developing an intervention prepared for efficacy 
testing in a future study. We will assess the variables listed in Table 3 before and after the interviews 
and conversations with their oncologists for preliminary data, which will inform the future study.  
Table 3. Measures 
Measure
Description
CAB Engagement
Number of CAB members who participate, number and length of meetings, 
and the discussion during the meetings. Discussions minutes will be analyzed 
using qualitative coding, and key themes will be reported and incorporated 
into the intervention. During the last CAB meeting, members will rate the 
intervention and overall study based on those key themes to measure how 
effectively we implemented their input. 
Recruitment
Reasons for non-eligibility and declining participation will be summarized; 
proportion of people approached and eligible for the study (target: 65%); 
proportion of eligible people enrolled (target: 70%). 
Retention
Retention rate at follow-up and reasons for dropout will be summarized.
Feasibility
Feasibility will be determined by meeting recruitment and retention goals 
(proportion of people approached and eligible for the study target 65%, 
proportion of eligible people enrolled target 70%, completion rate target 70%). 
Acceptability
4-item (AIM) measure of perceived intervention acceptability (α=0.89).49
Appropriateness
4-item (IAM) measure of perceived intervention appropriateness (α=0.87).49
Qualitative Experience 
Suggestions for improvement and overall helpfulness and acceptability of 
PINPOINT; perceived informativeness and quality will be treated. 
PINPOINT engagement
Recording website use (e.g., length of use), navigation patterns, and features 
used. 
Content Relevance
Type of benefits experienced and aspects of the intervention most liked and 
disliked  
Decisional Conflict
The Decisional Conflict Scale (DCS) measures 5 dimensions of decision 
making (feeling: uncertain, uninformed, unclear about values, unsupported; 
ineffective decision making) 
Decision Self-Efficacy
11-item scale measuring self-confidence in one’s decision-making about 
treatment, tumor genomic testing, and clinical trials enrollment (α=0.92).51,52 

 
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Decision Regret Scale
Valid and reliable 5-item self-report measure of distress or remorse following a 
healthcare decision (α=0.92).53 
Decision Satisfaction 
Scale 
6-item scale measuring self-satisfaction with health care decisions (α=0.86).72 
Shared Decision-Making
4-item survey measuring the extent to which healthcare providers engage 
patients in shared decision-making (α=0.78-0.87).54 
Empowerment
Single-item patient-reported outcome reflective of perceived empowerment as 
a result of intervention sequence (α=0.76).55 
Patient Engagement
13-Item measure that assesses knowledge, skill, and confidence for 
participant activation (PAM) and self-management. (α=0.92)56 
Knowledge
In consultation with content experts, we will develop and pilot a knowledge 
survey regarding precision oncology, immunotherapy, genomic testing to 
guide therapeutic decisions, and clinical trials. 
Attitudes, Values, 
Preferences 
Attitudes, preferences and intention to participate in a clinical cancer trial;57,58 
attitudes toward clinical trials, tumor sequencing; attitudes toward 
immunotherapy; values (e.g., risks/benefits); financial concerns;59 cancer 
fatalism;60 medical/health system distrust (α=0.77);61 perceived racial 
discrimination.62 
Tumor sequencing
Scheduled or completed tumor genomic sequencing at time of follow-up 
assessment. 
Demographic and Clinical 
factors 
Age, education, household income, race/ethnicity, marital status, employment 
and insurance, type of cancer, stage of disease, treatment, health literacy 
index.63 
 
C. Study Duration 
The study will last approximately two years. Each participant enrolled in the key informant interviews 
will be expected to attend a virtual interview session that lasts approximately 1.5 hours and 
complete written or online surveys. The total estimated duration for each participant is 2 hours. 
Each participant enrolled into the pilot testing will be expected to take part in a pilot testing session 
to view and utilize the educational website intervention, as well as complete two surveys. The total 
expected duration for each participant is up to 2 hours to view the educational website and complete 
baseline and follow up surveys. 
D. Endpoints 
We will conduct two rounds of key informant interviews, followed by prototype modifications after 
each round. We will also conduct one round of pilot testing.  
1.4 Preliminary Data 
Recently, we conducted a series of focus groups as part of the iCARE study: “Improving 
Communication About cancer Risk gEnes” (Protocol # 2019001647) to better understand their 
informational needs and preferences, and if and how patients with hereditary cancer mutations talk 
about their genetic testing results with family members in order to develop an evidence based web 
intervention to facilitate genetic health conversations and address the disparities gap related to cancer 
genetic services. While this study focused on hereditary cancer mutations and cancer risk, the identified 
facilitators and barriers to genetic testing and conversations about genetic health information, as well 
as preferences and suggestions for the online intervention, including sociocultural factors such as 
medical mistrust and fear, will be incorporated into our POINPOINT intervention prototype. 
Fifty-three participants were enrolled, including 15 Black/African American cancer patients, 5 
Hispanic/Latino cancer patients and 3 Black relatives and 6 Hispanic relatives. Participants were asked 
to complete pre- and post-discussion surveys and participate in a 2-hour online focus group discussion 

 
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using Microsoft Teams. Transcripts of the discussions and qualitative survey data were analyzed by 
two independent coders using a coding manual with a priori codes. Key themes were reported. 
Identified barriers included lack of relational closeness, cultural dynamics, geographic distance, young 
age, medical mistrust, fear of upsetting a family member, lack of genetic health information geared 
towards men, low digital health literacy, and barriers to accessing technology. Specifically, among 
Black and Hispanic or Latino focus group participants, concerns about discrimination, payment or 
insurance strain, and healthcare mistrust were expressed. Recommendations to combat these barriers 
were a family meeting with a doctor/provider, genetic test results explanation, appointment with genetic 
counselor, a website, books and articles, advice from family and friends or advice from doctor or 
provider. Some participants also expressed concerns with not being able to find cancer and genetic 
health information related to their specific personal and familial situations. Many participants liked the 
idea of creating a website to store personalized information about themselves and their families in order 
to make more educated decisions about genetic counseling and testing. The results of these focus 
groups will contribute to the prototype development. 
Additional data from the Community Advisory Board (CAB) feedback will be incorporated into the study 
design and help shape key informant interviews, the intervention design and content as well as the 
usability testing process. This study-specific CAB is comprised of Black patients and advocates, some 
of whom have served on our Cancer Community Action Board and Precision Oncology Workgroup. We 
will also include Black oncology healthcare providers and administrators for their perspectives on 
implementation. 
1.5 Sample Size Justification 
Previous pilot studies with at least 10 participants have demonstrated feasibility in behavioral 
interventions,64 but we will collect robust data from a variety of stakeholders. 
 
 
Key Informant Interviews 
 
We will recruit 20 Black cancer patients,  15 relatives or spouses of Black cancer patients, and  13 
oncology providers for the key informant interviews. We expect a total of  48 key informants to 
participate.  
 
Pilot Test Interviews 
We will pilot test the new prototype with 33 Black cancer patients. We expect a total of  33 to participate 
in this part of the study.  
The key informant interviews and pilot testing will stop when it is determined that data saturation has 
been reached. Data saturation is reached when no new information on the topic is gained.  
1.6 Study Variables 
 
A.  Independent Variables, Interventions, or Predictor Variables  
PINPOINT Intervention 
Once developed and fully implemented, newly diagnosed Black cancer patients will be asked to 
access and engage with the educational website/intervention prototype before their clinic visit or in 
the clinic immediately before their appointment with their treating oncologist. Based upon our 
experience, the vast majority of patients, including low income and minority patients, are able to 
use their phones, computers, iPads, and similar devices for decision-making interventions. The 

 
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foundational part of the educational website is expected to take approximately 10 minutes to 
complete, and the website will allow patients to seek additional information tailored to their 
preferences and needs, which may take up to an additional 20 minutes. It will contain factual 
content, graphics, narration, video clips, and chatbot, and will empower patients to ask questions 
and voice concerns with their clinician.  
We envision that the intervention be comprised of four main sections that include: 1) precision 
oncology; 2) clinical trials; 3) “Learn More” screens; and 4) discussion points and questions for the 
treating clinician. Additionally, users can interact with an optional chatbot (i.e., conversational 
agent). The precision oncology section will provide background information on precision oncology 
(including immunotherapy), who is eligible (including importance of tumor genomic testing to guide 
therapeutic decisions), issues to consider such as pros/cons, possible side effects/toxicities, 
common concerns/questions (e.g., financial burden, estimated response and survival rates), patient 
values/preferences, and importance of discussing these issues with the treating clinician (and 
strategies to foster communication). The clinical trials section will provide general clinical trial 
information, address common misconceptions (e.g., clinical trials are a last resort), facilitators and 
potential benefits, and barriers (e.g., awareness, randomization, placebo, distrust, fear, standard 
vs. experimental care). Although not all participants will be eligible for a clinical trial with molecularly 
targeted agents and/or immunotherapy, members of the CAB strongly recommended including this 
information as critical to alert patients to the possibility of being eligible for a trial in the future and 
would be useful to raise awareness and receptivity. “Learn More” screens will be optional and will 
allow patients to obtain more information on certain topics.  
The intervention prototype will also include a search function, short videos of patient testimonials, 
patient-provider interaction about immunotherapy and clinical trials, as well as a list of 
questions/concerns that the patient could print (or save electronically) and take with them to their 
provider visit. An optional chatbot will be available in the corner of the screen. Users can ask the 
chatbot questions about any of the material on the website or request additional information. The 
chatbot will also be able to help patients search for molecularly targeted and immunotherapy clinical 
trials and offer additional resources (such as websites and online support groups). 
B.  Dependent Variables or Outcome Measures  
The results of this study will contribute to intervention development, with efficacy testing in a future 
study. However, for preliminary data, we will assess the following outcome variables (described in 
the text and table above): feasibility, acceptability, appropriateness, usability, decisional conflict, 
decision self-efficacy, decision regret, shared decision-making, knowledge, empowerment, patient 
engagement, attitudes, and scheduled or completed tumor sequencing. 
1.7 Drugs/Devices/Biologics 
N/A 
  
A. Drug/Device Accountability and Storage Methods N/A 
1.8 Specimen Collection 
A. Primary Specimen Collection 
 
Types of Specimens: N/A 
 
Annotation: N/A  
 
Transport: N/A 
 
Processing: N/A 
 
Storage: N/A 
 
Disposition: N/A 

 
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B. Secondary Specimen Collection 
 
Types of Specimens: N/A 
 
Annotation: N/A  
 
Transport: N/A 
 
Processing: N/A 
 
Storage: N/A 
 
Disposition: N/A 
1.9 Data Collection 
A. Primary Data Collection 
 
Location: During the COVID pandemic, staff will conduct interviews and pilot testing sessions 
using their work phones and laptops at home. When able, they will conduct interviews and pilot 
testing sessions from Rutgers Cancer Institute . 
 
Process of Data Collection: Research staff trained in HIPAA compliance, human subject 
research ethics, and Good Clinical Practice will collect data. Eligibility data and contact 
information will be extracted from the EMR at participating sites by research staff. Eligibility will 
also be collected/confirmed during recruitment calls made by study staff. Survey data and 
interview data will be collected by research staff. Participants can complete the surveys online 
by accessing a secured link sent through REDCap. Participants may also choose to complete 
surveys on the phone or by paper. Study staff will enter the data from paper or phone surveys 
into REDCap and ensure accuracy. Key informant interview data will be transcribed verbatim 
from recordings by a transcription service. Transcripts will be coded by study staff. Website 
usage data will be captured by an application (e.g., Apollo) and stored without identifiers.  
 
Timing and Frequency: Data collection during the key informant interviews will occur during 
a pre-interview survey submitted virtually through RedCap or completed over the phone with 
trained research staff. During the phone interview data collection will occur via recorded 
interaction between the key informant and research staff when viewing study materials and 
answering study questions. During the pilot testing segment of the study participants will submit 
a pre-and-post interview survey via RedCap.  
 
Procedures for Audio/Visual Recording: Consent to record participants interviews via Zoom 
will be included in the consent form. Recordings will be stored on a HIPAA-compliant server 
and only accessible by study staff. The recordings will be sent via secure email to an approved 
vendor for transcription.  
 
Study Instruments: Key informants and pilot testing participants will complete questionnaires 
to assess demographics and self-report measures. These questionnaires will be refined with 
input from the CAB prior to study initiation. Demographic variables will include: age, education, 
household income, race/ethnicity, marital status, employment and insurance, type of cancer, 
stage of disease, treatment, and health literacy. The Health Literacy Index consists of three 
5point Likert scale items shown to be effective in detecting inadequate health literacy.63 We will 
also include open-ended and Likert-scale questions to evaluate knowledge, cancer fatalism, 
financial concerns, health system distrust, perceived racial discrimination, perceived risks and 
benefits of tumor testing, as well as attitudes, preferences, and intentions regarding clinical 
trials, tumor testing, and immunotherapy. These measures are described below. 
For patient pilot testing participants, we will also assess the following measures on the baseline 
and follow-up surveys: 1) Decision conflict will be measured using the 16 item Decisional 
Conflict Scale which measures personal perceptions of: a) uncertainty in choosing options) 

 
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modifiable factors contributing to uncertainty such as feeling uninformed, unclear about 
personal values and unsupported in decision making; and c) effective decision making such as 
feeling the choice is informed, values-based, likely to be implemented and expressing 
satisfaction with the choice. 2) The Decision Self-Efficacy Scale consists of 11 items measuring 
self-confidence in one’s decision-making about treatment, tumor genomic testing, and clinical 
trials enrollment (α=0.92).51,52 3) Decision regret will be assessed with a valid and reliable 5item 
self-report measure of distress or remorse following a healthcare decision (α=0.92).53 4) 
Participants will rate shared decision making using a 4-item instrument measuring the extent to 
which healthcare providers engage patients in shared decision-making (α=0.78-0.87).54 5) In 
consultation with content experts, we will develop and pilot a knowledge questionnaire regarding 
precision oncology, immunotherapy, tumor testing to guide therapeutic decisions, and clinical 
trials. 6) We will assess attitudes, preferences and intention to participate in a clinical cancer 
trial;57,58 attitudes toward clinical trials, genomic testing; attitudes toward immunotherapy; values 
(e.g., risks/benefits); financial concerns;59 cancer fatalism;60 medical/health system distrust 
(α=0.77);61 perceived racial discrimination.62 7) Empowerment will be measured using a patient 
reported enablement instrument (PEI, α=0.76). 8) Patient engagement will be drawn from the 
valid and reliable 13-item Patient Activation (PAM) measurement that assess patient 
knowledge, 
skill, 
and 
confidence 
for 
self-management 
(α=0.92). 
9) 
Intervention 
Appropriateness (IAM)  and Acceptability of Intervention (AIM) will be individually measured by 
4-item instruments (α =0.89) post intervention interaction. 49 10) Participants will also be asked 
to report whether they have scheduled or completed tumor genomic sequencing at time of the 
follow-up assessment. 11) The Satisfaction with Decision (SWD) scale consists of 7 items 
measuring satisfaction with one’s health care decisions, (α=0.86). 72 
Ethnographic Studies, Interviews, Or Observation: Key informant interview guides will be 
developed in collaboration with the study CAB. Probes/questions will explore experiences and 
preferences focused on Ottawa Decision Support Framework (ODSF)65  and Shared 
DecisionMaking Model (SDM)66,67 constructs such as: 1) beliefs and attitudes; 2) patient and 
family values/preferences for cancer treatment, including immunotherapy, 3) issues regarding 
consideration and understanding of treatment options, shared and informed decision-making, 
4) how to enhance preparation for discussion about precision oncology with the oncologist (e.g., 
example patient video, patient questions and concerns sent to oncologist as text message or 
email in advance of appointment); 5) informational needs, 6) information seeking, and 7) 
barriers and facilitators. During the interviews, participants will also view a prototype of the 
PINPOINT intervention, providing feedback as they explore the website and its features. The 
interviewer will take observational field notes regarding the participants’ reactions, and usage 
data will be collected using an app.  
 Included in the pilot testing session, participants will be asked additional questions to assess 
the following: 1) Risks and benefits of tumor testing will be rated on 5-point Likert scales. 2) 
Knowledge questions from the surveys will be included in the pilot testing session to determine 
user understanding. 3) Participants will be asked to rate overall helpfulness, informativeness, 
and quality of the intervention. 4) Empowerment will be rated using the PEI described above. 
 
Subject Identifiers: All participants will be assigned a study ID. Only the recruitment tracking 
database will link the ID with the participants’ identifying information, and access to the 
database will be restricted to only those study staff who are responsible for contacting 
participants. Identifying information, including name, address, and contact information (phone 
numbers and email addresses), will be extracted from EMR and/or will be obtained during 
recruitment calls by study staff and entered directly into the recruitment tracking database. 

 
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B. Secondary Data Collection  
 
Type of Records: N/A 
 
Location: N/A 
 
Inclusion/Exclusion: N/A   
 
Data Abstraction Form(s): N/A 
1.10 Timetable/Schedule of Events 
  Table 2. Study Timeline 
 
2.0 Project Management 
2.1 Research Staff and Qualifications 
Anita Y. Kinney, PhD, RN, FAAN, FABMR (Principal Investigator) is a Professor in the Department of 
Biostatistics and Epidemiology in the School of Public Health and Director, Center for Cancer Health Equity, 
Rutgers University, and Associate Director for Population Sciences and Community Outreach, Rutgers 
Cancer Institute . Much of her work focuses on addressing disparities and promoting health equity in clinical 
genetics, public health genomics and genetic risk communication in cancer patients and their families, and 
cancer care delivery. She has extensive experience with community engagement, leading multi-site 
randomized controlled trials of behavioral and informed decision-making interventions in diverse 
populations, settings and contexts and mixed-methods projects. She also has considerable clinical 
experience as a nurse/nurse practitioner in medical oncology settings at other cancer centers. Dr. Kinney 
will be responsible for overall scientific administration of the project and community engagement strategies, 
oversight of data collection including in-depth interviews, pilot testing, and the Community Advisory Board 
(CAB).   

 
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Shawna Hudson, PhD is Professor and Research Division Chief for the Department of Family Medicine and 
Community Health at the Rutgers Robert Wood Johnson Medical School (RWJMS). She is also a Professor 
in the Department of Health Education & Behavioral Science at the Rutgers School of Public Health (SPH) 
as well as an active and full research member of the Cancer Prevention & Control Program at Rutgers 
Cancer Institute . Dr. Hudson, a health services researcher trained in medical sociology and mixed methods 
research, specializes in primary care research. She has cultivated strong content expertise in cancer 
survivorship, working with vulnerable populations and the intersections of community health, primary care 
and specialty care. Dr. Hudson co-leads the Community Engagement Core of the New Jersey Alliance for 
Clinical and Translational Science, lending her expertise in minority patient recruitment, community 
outreach, mixed-methods research, and patient study cohort development. In the proposed study, Dr. 
Hudson will be a co-investigator and contribute to qualitative data collection and analysis. She will actively 
contribute to interpreting data and reporting findings at conferences and in peer-reviewed publications.  
Shridar Ganesan, MD, PhD is a Professor of Medicine, Associate Director for Translational Science, 
Director of Comprehensive Genomics Shared Resource, Co-Leader of Clinical Investigations and Precision 
Therapeutics Program, and Section Chief, Cancer Biology at the Rutgers Cancer Institute . Dr. Ganesan 
has extensive experience in clinical analysis of patient data in precision medicine settings as well as 
translational study of solid tumors. He is a board-certified medical oncologist and has considerable 
experience in the cancer care delivery, genomic sequencing, and precision medicine. As co-investigator, 
Dr. Ganesan will provide clinical expertise and contribute to website content development and refinements, 
interpreting data, and reporting findings at conferences and in peer-reviewed publications. 
Coral Omene, MD, PhD is a board-certified medical oncologist specializing in breast cancer treatment and 
research, with a focus on cancer health equity. She has expertise in precision oncology research for breast 
cancer, particularly the triple negative subtype which disproportionately afflicts African American women. 
Dr. Omene is also an advocate for clinical trials participation in diverse populations. As co-investigator, Dr. 
Omene will provide clinical expertise, contribute to website content development, engage with the CAB, 
and assist with data interpretation and dissemination of results at conferences and peer-reviewed 
publications. 
Additional research support will be fully trained on all study procedures, and possess necessary experience 
required to perform their tasks. 
2.2 Research Staff Training 
All staff will be properly trained with CITI, EPIC and receive full protocol training.  
2.3 Resources Available 
Drs. Kinney, Hudson, Ganesan, and Omene have their own offices at RBHS Campus in New 
Brunswick. This space includes adjoining administrative and research staff space. All project staff have 
their own desk and file storage space. If necessary, for public health and safety, investigators and staff 
may work remotely from home using Rutgers-issued laptops. The team has email and internet access, 
shared file storage space, and geographically distributed printing. Study-related data will be stored on 
a HIPAA-compliant server. 
2.4 Research Sites 
Recruitment will take place at The Rutgers Cancer Institute Both key informant interviews and usability 
testing will be held online and hosted by study staff using HIPAA-compliant Zoom. Participants may 
also call into the sessions using a telephone.  
3.0 Multi-Center Research 
N/A 

 
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4.0 Subject Considerations 
4.1 Subject Selection and Enrollment Considerations  
A. Method to Identify Potential Subjects 
In collaboration with the CAB, we will use purposive, snowball sampling to identify and select a 
sample of 48 participants for the key informant interviews.32 These informants will be selected for 
their knowledge and ability to speak about their needs, preferences, experiences and the factors 
that impact tumor impact tumor testing, guideline-based immunotherapy treatment, and clinical 
trials participation among Blacks from their perspectives as patients, relatives, and providers 
(including providers from community health sites that treat a large number of Black patients). We 
will select up to 20 participants representing each segment (patient, relative, provider). We will work 
with the CAB to identify and contact potential informants through their social and professional 
networks. In addition, a trained staff member will conduct chart reviews of electronic medical 
records (EMR) at The Rutgers Cancer Institute , University Hospital, Newark and RWJBH for 
patients who may be eligible. Additional recruitment will occur through community outreach, 
Rutgers listservs, RWJBH, UH, and patient portals.  
Following key informant interviews 33 newly diagnosed Black cancer patients will be recruited from  
Rutgers Cancer Institute , University Hospital, Newark and RWJBH as participants in a pilot study. 
B. Recruitment Details 
Once a list of potential key informants is developed, the Program Assistant will make initial contact 
via email, letter, and/or telephone to invite them to participate in the study and schedule a telephone 
screening call. For patients that are identified from the medical record system, research staff will 
send a recruitment letter to their preferred mailing address and wait one week for opt out return 
letter. If research staff does not hear back from patient through mail, research staff will begin to 
attempt making contact via phone. Participants may also be recruited face-to-face in the clinic. 
Flyers and brochures will be used for community outreach efforts and word of mouth.  
For pilot testers, potential participants will also be recruited from RWJBH and UH via clinician 
referral. Research staff will provide study flyers for clinicians to inform potentially eligible 
participants about this study. Once providers receive participants' permission to be contacted by 
study staff, providers will notify our research team. Staff will either call patients or send out a letter 
inviting them to participate in the study. Research staff will also identify potentially eligible 
participants and ask for permission from the provider to approach participants. Research staff will 
contact individuals who do not opt out within one week, explain the study, and recruit those who 
are interested in participating. 
C. Subject Screening 
Interested individuals will be further screened for eligibility via telephone by study staff using a 
recruitment script, developed in collaboration with the CAB. 
Inclusion Criteria 
Patient key informants must be age 18 or older, self-identify as Black/African American, 
diagnosed with cancer or currently living with cancer, able to read and speak English fluently, 
able to provide  informed consent, and able to complete surveys and an in-depth interview. 
Relative key informants must be a spouse, blood relative, or caregiver of a cancer patient who 
identifies as Black/African American. They must be age 18 or older, able to read and speak 
English fluently, able to provide  informed consent, and able to complete surveys and an in-
depth interview.  

 
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Provider key informants must be either a physician, nurse, social worker, patient navigator, or 
financial counselor. They must work in an oncology setting at a participating clinical site, be 
able to read and speak English fluently, able to provide electronic informed consent, and able 
to complete surveys and an in-depth interview. 
Patient pilot testers must be age 18 or older, self-identify as Black/African American, newly 
diagnosed with a solid tumor (Stage I-IV) have not yet consulted with their oncologist regarding 
treatment options, life expectancy of at least six months, able to read and speak English 
fluently, able to provide informed consent, and able to complete two surveys. 
Exclusion Criteria 
Key informants and pilot testers will be excluded from the study if they do not meet the inclusion 
criteria. Pilot testers will be excluded from the study if they previously participated as a key 
informant and also do not meet inclusion criteria. 
4.2 Secondary Subjects 
N/A 
4.3 Number of Subjects 
A. Total Number of Subjects 
The total number of key informants will be  48. The total number of pilot testing participants will be  33. 
B. Total Number of Subjects If Multicenter Study:N/A 
C. Feasibility 
Participants will be recruited using a variety of methods, including snowball sampling, community 
recruitment, social media and patient portal recruitment, and reviews of EMR data. We anticipate no 
problems reaching our target accrual goals. 
4.4 Consent Procedures 
A. Consent Process  
 
Location of Consent Process 
Informed consent will be obtained prior to key informant interviews and usability testing via 
REDCap with an electronic signature from eligible participants after study staff has ensured 
complete comprehension of the informed consent document during a scheduled call between 
the study staff and participant. If the participant does not have access to the internet, study 
staff can mail the consent form to their preferred mailing address and go over the consent over 
the phone at a scheduled time to ensure competency. Participants will also complete a paper 
or electronic HIPAA authorization for study staff to abstract data from the EMR. Individuals will 
not be eligible to participate in the study without completing both the informed consent and 
HIPAA authorization. 
Ongoing Consent 
N/A 

 
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Individual Roles for Researchers Involved in Consent 
Trained study staff will provide the electronic consent form and verbally review the consent 
form with each participant prior to the interview/pilot testing session. If the participant does not 
have access to the internet, study staff can mail the consent form to their preferred mailing 
address and go over the consent over the phone at a scheduled time to ensure competency. 
Study staff will then save and document all electronic informed consent documents from 
REDCap prior to distributing or emailing baseline surveys. 
Consent Discussion Duration 
The informed consent discussion is expected to take approximately 5 minutes. 
Coercion or Undue Influence 
We will inform participants that they are not required to take place in the key informant 
interviews or usability testing and that they are free to leave at any time. Participants will be 
informed that they have the choice to either dial-in using a phone, video call in or only audio 
call in via Zoom meeting and must have access to a computer. We will also remind participants 
that they do not need to share or discuss anything that makes them feel uncomfortable. 
 
Subject Understanding 
After reviewing each section of the consent form, study staff will pause and ask for questions 
and ensure subject understanding of the entire consent form. 
B. Waiver or Alteration of Consent Process Waiver or Alteration Details N/A 
Destruction of Identifiers N/A Use of Deception/Concealment 
N/A 
a. Minimal Risk Justification 
N/A 
b. Alternatives 
N/A 
c. Subject Debriefing N/A 
C. Documentation of Consent Documenting Consent 
Trained research staff members will perform full informed consent about the procedures of the 
study for all potential participants. Study staff will provide or mail or email the informed consent 
document to those who screen eligible and review the elements of consent in-person or by 
telephone, answering questions and ensuring complete comprehension. Participants will be 
instructed that they may decline to participate or withdraw from the study at any time. They will 
be assured that their decision to give, withhold, or retract consent will not in any way influence 
their present or future medical care. The person obtaining consent will answer any questions 
that potential participants have. If, at a later time, they have any questions, they will be told that 
they can contact the principal investigators and will be given their telephone numbers. 
Participants will also be informed that if they have any questions regarding their rights as 
research participants, they may contact the Office of Research at Rutgers University; the 
telephone numbers will also be listed on the informed consent form. Participants will also 
complete a paper or electronic HIPAA authorization for study staff to abstract data from the 
EMR. 
Waiver of Documentation of Consent – Consent will be taken over the telephone by 
Rutgers Cancer Institute study staff if patients opt to consent verbally.  
4.5 Special Consent/Populations 

 
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 
Minors-Subjects Who Are Not Yet Adults Parental Permission N/A Non-
Parental Permission N/A Assent Process N/A Documentation of Assent N/A 
Reaching Age of Majority During Study N/A B. Wards of the State 
N/A 
 
Research Outside of NJ Involving Minors 
N/A 
C. Non-English-Speaking SubjectsProcess for Non-English-Speaking Subjects N/A 
Short Form Consent for Non-English Speakers N/A 
D. Adults Unable to Consent / Decisionally Impaired Adults 
N/A 
NJ Law-Assessment of Regaining the Capacity to Consent N/A 
Capacity to Consent a. NJ Law-Selecting A Witness  
N/A 
b. Removing a Subject 
N/A 
4.6 Economic Burden and/or Compensation for Subjects 
A. Expenses  
The only expense that participants are expected to incur is for parking at Rutgers Cancer Institute  
if needed for in-person interviews, but we will validate the parking for participants who use the 
valet service so that they will not have to pay for valet parking. 
B. Compensation/Incentives 
Participants will receive a $50 gift card after their key informant interview session for their time. 
Participants identified as providers will be excluded from receiving the gift card incentive due to 
institutional policies prohibiting acceptance of this kind of incentive.  
Participants taking part in the pilot testing will receive a $50 gift card after completing each 
survey. If participants complete both surveys and view all the main sections of the PINPOINT 
educational website (About, Personalized Cancer Treatment, Clinical Trials, and Resources), 
they will receive an additional $50 gift card. If the study participants complete all study materials 
online and within 1 week of receiving them, participants will receive an additional $25 for a 
potential of $175. The gift cards will be distributed to each participant after he/she has completed 
the baseline and follow-up survey. Participants may mail their surveys back to the Cancer Health 
Equity Office. Participants will be provided with free valet parking for in-person pilot testing if 
need be.  
C.  Compensation Documentation 
Participants are provided compensation at the end of the key informant interview and for the pilot 
testing session. Gift cards will be mailed following the completion of the baseline and follow-up 
surveys for the pilot test participants. Project staff will maintain a checklist of activities required for 
each participant. Among the items on the checklist is one to ensure that they received their 
compensation. This information is also input by project staff into a participant tracking database. 
Participants will also sign a receipt form to acknowledge receipt of the gift card and give or mail it 
to the study staff (using a prepaid envelope). 
  
4.7 Risks of Harm/Potential for Benefits to Subjects 

 
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A. Description of Risks of Harm to Subjects Reasonably Foreseeable Risks of Harm 
The potential risks are judged to be minor, as they are similar in many ways to risks experienced 
by those who participate in shared decision making with their providers, online education and 
information-seeking about health topics, and tumor sequencing outside of a research study. 
There are potentially three main risks to participants in this study: 
Initial discomfort/embarrassment. Participants will be asked questions of a sensitive or 
personal nature, which potentially could cause some discomfort or embarrassment in 
answering these types of questions. 
Concerns about televideo sessions with website tracking and screensharing capability. 
Although some adults may feel more comfortable utilizing televideo, website tracking, and 
screensharing technology, others may feel less comfortable with this process and have 
concerns.  
Privacy and loss of confidentiality. All efforts will be taken to maintain privacy and confidentiality 
as described below. Nevertheless, there is still the potential for unintentional breach of 
confidentiality for participants.  
Methods of protecting against these risks are outlined below. 
Risk of Harm from an Intervention on a Subject with an Existing Condition 
This minimal risk study is not expected to have any additional risk of harm for individuals with 
existing conditions. 
Other Foreseeable Risks of Harm 
N/A 
Observation and Sensitive Information 
The presence of a researcher is necessary for the interviews and is not expected to negatively 
impact the interview dynamic.  
B. Procedures which Risk Harm to Embryo, Fetus, and/or 
Pregnant Subjects: N/A 
C. Risks of Harm to Non-Subjects: N/A 
D. Assessment of Social Behavior Considerations 
In the unlikely event that during participation in the study, a participant indicates that he or she may 
be in imminent danger to themselves or others, the patient’s physician will be contacted by the 
research team immediately after the interview. The physician or their designee will follow up with 
the participant on the same day, and if necessary, arrange for treatment.  
 
E. Minimizing Risks of Harm 
All participants will provide informed consent before the start of the interviews/pilot testing. The 
autonomy of participants will be protected by informing all participants of the purpose of the study 
and allowing them to opt out of participation without repercussion. Participants will also be able to 
refuse any question they do not want to answer and withdraw from the study at any time.  
Initial discomfort/embarrassment. Participants will be asked questions of a sensitive or personal 
nature (e.g., medical history, psychological functioning), which potentially could cause some 
discomfort or embarrassment in answering these types of questions. All study staff will be trained 

 
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to deal with these situations, and every effort will be made to address each participant’s concerns 
or problems in the most supportive and empathic manner. Surveys will be facilitated by staff trained 
to be both sensitive and responsive. Confidentiality will be maintained at all times. 
Concerns about tele-video sessions with website tracking and screensharing capability. Key 
informant interviews will be conducted and recorded using HIPAA compliant Zoom. Participants will 
be provided with written instructions for using this technology and research staff will troubleshoot 
any technical problems by telephone. The intervention prototype is a secure, password-protected 
website that tracks user analytics. These data will be de-identified and stored on HIPAA-compliant 
servers. 
Privacy and loss of confidentiality. All efforts will be taken to maintain privacy and confidentiality.  
We are aware that data will contain demographic and personal health information, and consistent 
measures will be employed to protect the security and confidentiality of these data, as described 
below. Tracking, survey, and interview data will be securely stored in a study database. Participants 
will be assigned a study ID, and the analyses will be limited to the variables necessary for the 
completion of the proposed study, and results will be reported in aggregate so that individuals are 
not identified. The only identifiable information that will be linked to the study ID on the surveys is 
the participant’s preferred mailing address. The purpose of confirming their preferred mailing 
address is to send the incentive for participation. This identifiable data will be stored in a password 
protected and encrypted data base that only study personnel have access to. Study publications 
or presentations resulting from this research will not identify participants by name but will present 
only aggregate data. 
Certificate of Confidentiality 
N/A 
Provisions to Protect the Privacy Interests of Subjects 
All participant demographic, clinical, interview, intervention usage, and patient-reported data 
will be stored in the Rutgers Cancer Institute database. These data will be maintained on a 
secure computing infrastructure behind the institutional firewall certified to store protected 
health information. We will take consistent measures to protect the confidentiality of these data. 
The only identifiable information that will be linked to the study ID on the surveys is the 
participant’s preferred mailing address. The purpose of confirming their preferred mailing 
address is to send the incentive for participation. This identifiable data will be stored in a 
password protected and encrypted data base that only study personnel have access to. All 
investigators and project staff will be required to complete the online human subjects and good 
clinical practice training, which is mandated by the Institutional Review Board (IRB). Study IDs 
will be assigned for individuals who participate to help maintain confidentiality. All identifying 
data will be stored in secured and password protected files separate from all other research 
information, which will be identified by study identification number alone. The study database 
will be restricted to only those individuals who are authorized to work on the study and have 
appropriate protection of human subjects’ certification. Individual user accounts with 
passwords will be used to log and restrict access to the database. Specific privilege 
assignments within the database will also be employed to limit the types of functions that 
authorized users can perform to those functions that are appropriate for their role in the study. 
Access to individually identifiable private information about participants will be limited to the 
Principal Investigators and those co-investigators or study team members involved in duties 
related to direct patient contact (e.g., research staff performing recruitment or interviews). 
Other co-investigators or study team members not involved directly in recruitment activities 
(e.g., statistician, data analyst) will not have access to identifiable participant or patient 
information. The use of network firewall technologies should prevent data security problems 

 
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that include unauthorized internal access to data, external access to data, and malicious intent 
to destroy data and systems. Controlled user access will ensure that only appropriate and 
authorized personnel are able to view, access, and modify study data.  All modifications to data 
will document user access and data associated with the modification, as well as values prior 
to modification.  
 
F. Potential Benefits to Subjects 
There are no guarantees that participants will benefit from taking part in this study, but people often 
find satisfaction in contributing to research. In addition, participants may benefit from engaging with 
the PINPOINT prototype, which is designed to a) improve knowledge and awareness about clinical 
trials and precision oncology among Black cancer patients and families; b) foster informed/shared 
decision-making regarding guideline-based precision therapies; and c) increase favorable attitudes 
about clinical trials participation in an underrepresented population to speed the translation of 
research findings into practice and contribute to a needed evidence base of racially diverse 
precision oncology trials. 
The benefits of this study include significant potential for public health impact. This study will 
contribute to the development of an online intervention, which may increase representations of 
Black cancer patients in clinical trials, improve scientific understanding of how diverse populations 
respond to innovative cancer treatments, improve diffusion of innovative cancer treatments in 
underserved communities, reduce mistrust and improve communication and shared decision-
making between Black cancer patients and their providers, and improve cancer health equity. 
We are balancing the risk of potential discomfort and the low risk of loss of privacy against 
developing a tool to reduce cancer health disparities. We believe the benefits to research subjects 
and others outweigh the minor risks of participation.  
5.0 Special Considerations 
5.1 Health Insurance Portability and Accountability Act (HIPAA) 
We will work with the CAB to identify and contact potential informants through their social and professional 
networks. In addition, a HIPAA-trained staff member will conduct chart reviews of electronic medical records 
(EMR) at  Rutgers Cancer Institute , University Hospital, Newark and RWJBH for patients who may be 
eligible. Additional recruitment will occur through community outreach, Rutgers listservs, RWJBH, UH, and 
patient portals.  
Once a list of potential participants is developed, study staff will make initial contact via email, letter, and/or 
telephone to invite them to participate in the study and schedule a telephone interview. Participants may 
also be recruited face-to-face in the clinic. Interested individuals will be further screened for eligibility by 
telephone.  
Tracking, survey, and interview data will be securely stored in a study database. Analyses will be limited to 
the variables necessary for the completion of the proposed study, and results will be reported in aggregate 
so that individuals are not identified. Study publications or presentations resulting from this research will 
not identify participants by name but will present only aggregate data. 
5.2 Family Educational Rights and Privacy Act (FERPA) 
N/A 
5.3 Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
N/A 

 
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A. Special Populations 
N/A 
5.4 General Data Protection Regulation (GDPR) 
N/A 
5.5 NJ Access to Medical Research Act (Surrogate Consent) 
N/A 
6.0 Data Management Plan 
6.1 Data Analysis 
Digital recordings of key informant interviews will be transcribed verbatim and transcripts and qualitative 
data from surveys and field notes will be managed using qualitative data analysis software. Independent 
coding of data will be conducted by at least two team members with discrepancies reviewed at team 
meetings and resolved through consensus.68 Investigators will compare and contrast interviews within and 
across stakeholder groups as part of an iterative cycling process of reading, summarizing, and re-reading 
the data using the five phases of qualitative interpretive analysis described by Miller and Crabtree:32 1) The 
describing phase will begin with an immersion-crystallization analysis approach in which data are initially 
read to identify overarching, organizational themes.69 2) Themes are used to create a “codebook” that is 
used to tag and sort data.43 Coded text is sorted and summarized using an editing style to create an 
organizing scheme for interpretative analysis. 3) The connecting phase makes sense of the data at a new 
level. Themes and patterns are captured in 5-10 page “analytical narratives” of each stakeholder group. 4) 
The corroborating/legitimating phase seeks additional data to confirm or refute insights from initial analyses 
using multiple data sources and investigators to review interpretations to control bias. 5) The representing 
the account phase, shares and refines final findings with target audiences and our advisory committees in 
the form of summaries and visual presentations. This five-step process results in interpretive summaries of 
stakeholder perspectives, particularly with respect to the core features that enhance knowledge and 
awareness about precision oncology and clinical trials, preparation for discussion about precision therapies 
with the oncologist, and informed and shared decision-making. To validate the accuracy of the findings, the 
investigators will employ mixed method research best practices,30,70,71 including member checking, 
assessing reliability with two coders and triangulation, and presentation of negative or discrepant data to 
the CAB to ensure interpretations are minimally impacted by bias. 
Frequencies and means will be calculated and reported for demographic variables (age, education, 
household income, race/ethnicity, marital status, employment and insurance, type of cancer, stage of 
disease, and treatment). Health literacy will be scored, and the mean will be reported. Open-ended survey 
items will be coded and analyzed using the qualitative analysis methods described above. Mean ratings of 
overall helpfulness, perceived informativeness, and quality of the intervention will be measured using a 
5point Likert scale, with a mean value of 4 representative of positive results.  
We hypothesize that use of PINPOINT prototype will yield increased knowledge and more positive 
attitudes/intentions regarding clinical trials, tumor sequencing, and immunotherapy (at follow-up). Using t-
tests, we will examine change in these variables. We also predict that participants will report low levels of 
decisional conflict based off a 16 item 5 response categories Decisional Conflict Scale (DCS) and decision 
regret measured by taking the mean of the 5 items and converting them to a score ranging from 0-100 by 
subtracting by 1 and multiplying by 25, with higher numbers indicating greater regret.53 Additionally, we 
predict high levels of shared decision-making following engagement with the intervention. Shared decision 
making will be a 4-item measurement. 54 Each response is scored as either a 0 (a little, not at all, No) or 1 
(yes, a lot, or some). The total points are summed and result in a score of 0-4 with higher scores indicating 
more shared decision-making. We also predict that PINPOINT will yield increased levels in perceived 

 
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benefits of tumor testing. Participants will rate on 5-point Likert scales the perceived benefits and perceived 
risks of tumor testing. T-tests will be conducted to assess change in perceived benefits.  Because this is a 
small pilot test, we will not conduct significance testing but analyze the data for patterns and appreciable 
differences. These data will inform a larger randomized control trial that will test efficacy of the intervention.  
We will also calculate the number of participants who scheduled or competed tumor genomic sequencing 
at the time of follow-up.  
Participants will be asked to complete a baseline and follow-up survey to assess demographics, knowledge, 
preferences, beliefs, and attitudes, as described above. These data will provide preliminary evidence 
regarding feasibility, acceptability, and preliminary efficacy of the intervention.  
6.2 Data Security 
We will take several precautions to avoid any breach of confidentiality. We will use identification 
numbers instead of names of participants on all study forms and in any study database. The numbers 
and names will be linked to a master list that will be accessible only to the research team. The master 
list will be kept in a locked file cabinet and in a computerized tracking system that will be password 
protected behind the Rutgers CINJ firewall. All study records and forms will be stored in locked file 
cabinets and password protected files on secure servers. Recordings from the CAB meeting and key 
informant interviews will be stored securely with access limited to research team members. 
6.3 Data and Safety Monitoring 
N/A 
6.4 Reporting Results 
A. Individual Subjects’ Results  
After concluding this study as well as the future efficacy study, and after developing manuscripts 
for publication, we will disseminate the results of our work to participants, and their families. All data 
will be reported in aggregate and no individual identifying information will be disclosed. 
B. Aggregate Results N/A 
C. Professional 
Reporting 
Results will be published in scientific journals and presented at conferences. No identifying 
information will be shown in any of these presentations, abstracts, or manuscripts. 
D. Clinical Trials Registration, Results Reporting and Consent Posting 
The current study will not require clinical trials registration, results reporting, and consent posting. 
The future clinical trial will follow all federal regulations as necessary. 
6.5 Secondary Use of the Data    
The data, without identifiers, will be used for a future large-scale, randomized control trial that will test the 
efficacy of the refined intervention prototype. This is stated in the informed consent document.  
Participants will be asked at the completion of their surveys whether or not they would like to be contacted 
for future research by the research study team. The surveys and survey data are stored in a password 
protected and encrypted data base. Participants will be told that they have the option to decline future 
participation in research studies or be open to being contacted again by only the research team.  
7.0 Research Repositories – Specimens and/or Data 
Data entry and storage systems and procedures are in place at Rutgers Cancer Institute. With IRB approval, 
all participant demographic, clinical and patient-reported data will be stored in the Rutgers Cancer Institute 
study database. These data will be maintained on a secure computing infrastructure behind the institutional 
firewall certified to store protected health information. We will take consistent measures to protect the 

 
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confidentiality of these data. All investigators and project staff will be required to complete the online human 
subjects and good clinical practice training, which is mandated by the Institutional Review Board (IRB). 
Study IDs will be assigned for individuals who participate to help maintain confidentiality. All identifying data 
will be stored in secured and password protected files separate from all other research information, which 
will be identified by study identification number alone. A study database will be hosted at Rutgers Cancer 
Institute in New Brunswick, NJ on secure computing servers with secure data entry and submission for all 
other sites. The REDCap study database, into which information about participant contact and data from 
all surveys will be entered, will be restricted to only those individuals who are authorized to work on the 
study and have appropriate protection of human subjects’ certification. Individual user accounts with 
passwords will be used to log and restrict access to the database. Specific privilege assignments within the 
database will also be employed to limit the types of functions that authorized users can perform to those 
functions that are appropriate for their role in the study. Access to individually identifiable private information 
about participants will be limited to the Principal Investigators and those co-investigators or study team 
members involved in duties related to direct patient contact (e.g., genetic counselors and research staff 
performing telephone interviews for participants who do not respond to mailed surveys). Other 
coinvestigators or study team members not involved directly in recruitment activities (e.g., statistician, data 
analyst) will not have access to identifiable participant or patient information. The use of network firewall 
technologies should prevent data security problems that include unauthorized internal access to data, 
external access to data, and malicious intent to destroy data and systems. Controlled user access will 
ensure that only appropriate and authorized personnel are able to view, access, and modify study data.  All 
modifications to data will document user access and data associated with the modification, as well as values 
prior to modification. The informed consent document will outline the plan to utilize the de-identified data in 
a future research study testing the efficacy of the developed intervention. 
8.0 Approvals/Authorizations 
A Letter of Cooperation from Oxford Communications is attached. This letter outlines the scope of work for 
the development of the PINPOINT web-based tool and its maintenance. 
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