All right, good morning, everyone. So happy to be back here to welcome you to the SBRB seminar series. We've ran this series since just after the founding of the Social and Behavioral Research Branch and we gather twice a year to recognize and bring to NIH leaders at the intersection of genomics and society. Really pleased to be rebooting this seminar series after the pandemic and to welcome our branch chief Laura Caley in order to welcome our featured speaker. Thank you for being here. Thanks Susan for passing the mic and I want to also say good morning. It's so nice to see everyone here in person. So thank you for coming out on this drizzly day to Building 50 to hear from our esteemed colleague Anita Kinney. And I really want to say that Anita is a wonderful researcher and friend. I've known Anita since I did my postdoctoral research at MD Anderson Cancer Center where Anita was a nurse practitioner and also doing her doctorate. So Dr. Kinney earned her doctorate in epidemiology with a minor in behavioral science from the University of Texas School of Public Health in Houston and then after she completed her doctorate she went on to do a postdoctoral fellowship under an NCI funded R25T at the Lindberger Comprehensive Cancer Center at the University of North Carolina at Chapel Hill. Dr. Kinney is currently a distinguished faculty member at Wreckers University. She holds a lot of positions there. She's a professor in the Department of Biostatistics and Epidemiology, the director of the Center for Cancer Health Equity in the School of Public Health, the associate director for Cancer Health Equity and Engagement at Wreckers Cancer Institute of New Jersey and the director of Screen NJ which is a statewide cancer prevention and screening program in New Jersey. Dr. Kinney's research program focuses on cancer prevention and control where she has a particular emphasis on the genetic behavioral and environmental factors that influence cancer risk and outcomes. She really uses a transdisciplinary approach in her work. Dr. Kinney has made substantial strides in advancing our understanding of how to mitigate the burden of cancer within at-risk communities and she's engaged in several clinical trials at the moment. I'm not sure which of those she's going to talk about but just wanted to mention that she's also translating what she's learned into clinical practice which I think is really resonates with me as we try to do service through our research. She is a staunch advocate for health equity and social justice. Dr. Kinney is committed to addressing disparities in cancer care and promoting access to quality health care for all individuals regardless of their background and socioeconomic status and I have to say her efforts to empower communities and promote health equity have really earned her international recognition. So today Dr. Kinney is here with us in person and she's going to speak about developing alternative cancer care delivery models with an equity lens. Please join me in welcoming Dr. Kinney to NIH. Thank you for that lovely introduction. I don't have slides but I just remembered when you were introducing me, I knew this but it brought it to the forefront of my mind. My first R01 was funded by NHGRI. Most of my funding has since come from NCI. I do have a grant from NHLBI looking at lung cancer screening, decision coaching and patient navigation intervention system-wide. My first grant focused on it was the first study of African American kindred, a large family's related by blood who carried a BRCA mutation. I was at the University of Utah and as you know in Utah, Mark Skolnick and others cloned BRCA 1 and 2, it was patented, start myriad genetics and this was a population that had participated in the genetic epidemiology research and my research was and I was funded by NIH to develop a culturally targeted intervention to disclose genetic test results for those who wanted clinically approved genetic testing and that was quite an adventure. So I've been in the equity and disparities research world for a very long time. I'm going to share some of my current research with you that I thought might be relevant to this group in a large area of my focus. Just to set everybody on the same page, promoting equity and precision cancer control is a national priority. We aim to ensure that all segments of the population have access to cancer information and guideline concordant care, representation in research matters and in order to reduce disparities, we need to address multi-level factors. Debbie Craig and Tua Paul and I published a paper years ago where we outlined factors to consider to address disparities in translational clinical community genomics. So interventions and considerations are at the individual level, interpersonal level, system level and community and policy levels and of course equity is important across all of those levels. This model is drawn from, many of you know, the socio-ecological framework which we applied to more clinical genetics. I'm preaching to the choir here but just for those who are trainees, hereditary cancer accounts for about 10 to 15 percent of cancers caused by an inherited mutation. It's typical to see a recurring pattern across two or three generations but in oncology now we identify cancer patients and often don't even need or use a family history. The guidelines are based on characteristics that we can identify in the cancer patient without knowledge of family history which has really expanded access in identifying patients and families who are at risk for hereditary cancer. So most cancers are sporadic, often when a cancer patient is diagnosed, they say, I don't have cancer in my family, how did I get cancer? So we need to explain that to patients that many don't have identified germline genetic risk factors. So strategies to improve access to genetic services and promoting equity are needed. Genetic testing can enhance prevention screening treatment and cascade testing, that's a term we use where we can test relatives of patients where there's a known mutation in a family. Genetic testing has been available for over 20 years. The pace of translation has been disappointingly slow. A low uptake in cancer patients, less than 30 percent of cancer patients who carry deleterious mutation or meet the criteria for testing have been tested and less than 10 percent of people with pathogenic variants, that's the term where we used to use mutation, now it's PV or pathogenic variant, have had germline testing. Precision medicine can improve outcomes, there's lots of data about that and is cost effective. However, there's many barriers to implementation. So I mentioned some of these things, I'm going to go over this slide. So access issues are prevalent, there are low referral rates for genetic counseling and testing, the minority of cancer patients and actually relatives or patients in primary care settings are identified as at increased risk and referred to genetic services when they meet the criteria. Access issues can relate to myriad of things, including a shortage of genetic professionals in rural and community settings, there are expanded indications for genetic testing in the cancer world, you know, the criteria for testing has expanded so much, it used to be really narrow and hard to follow. Now all patients, for example with colorectal cancer are recommended to get genetic testing where in the past it was a very narrow criteria, hard physicians and other providers to actually know what the guidelines are and interpret them. And so since there's expanded guidelines, there's increased demand for testing, but few not enough genetic professionals. So the NCCN and ASCO, the American Society of Clinical Oncology and NCCN is the national comprehensive cancer network, they issue guidelines for a variety of cancer issues, including genetic testing. And so breast cancer, for example, the guidelines just expanded, they were relatively narrow before, genetic testing for women, 45, age 45 or less if they were diagnosed with breast cancer and then other ages depending on their family history. Now all women diagnosed at 65 or less are recommended to have testing, those who have metastatic cancer and there's other recommendations as well. So cancer genetic risk assessment is a comprehensive consultation. It's a clinical service that involves the assessment of personal and family history, genetic testing when appropriate, and risk management recommendations. Pre-test genetic counseling is recommended and is still considered the standard of care. Patients often need to see a genetic counselor to help guide them whether or not they should be tested and help make decisions, help patients make informed decisions whether or not they should be tested. And then when test results are available, we either call it a test result disclosure session or a post-test genetic counseling session. And that involves the discussion about results and their implications for the patient and their relatives. So ways to improve access to genetic testing can occur again at multiple levels and multiple strategies can be used. Population traceback case ascertainment involves the retrospective identification of carriers of pathogenic variants. Goli-Samimi at NCI had coined this term traceback approach. There are many cancer patients and family members who could carry deleterious pathogenic variant and they have not been referred for genetic testing. So in the clinical oncology world, many more patients that are newly diagnosed have got tested, but that's still suboptimal in terms of testing rates. And there's evidence-based alternative care delivery models. I did have slides, but I cut some of them out because I get so excited about some of the work we do. There's not enough time, but Marlena, who I met with as a trainee, and asked me about changing policy. So Mark Schwartz and I had conducted two simultaneous trials. They were non-inferiority trials to assess whether telephone genetic counseling and testing was non-inferior to in-person counseling or testing. At that time, providers would not do telephone counseling because of a variety of concerns. Concerns about psychological distress. Patients wouldn't be able to make informed decisions. So the quality of decision was a concern and then insurance reimbursement. And those two trials, we both were involved with them. His trial related to self-referred patients. So patients who were self-referred at cancer centers along the east coast about testing and my study where I was a PI involved recruiting patients from statewide cancer registry linked to the Utah population database. So we had information, not only pathologically confirmed cancers, but some genealogical information that we could or could not use for recruiting patients. And basically our results were essentially the same. So we used proactive public health kind of recruitment, clinic-based recruitment, and we found that telephone counseling was not inferior to in-person counseling. And that helped change policy in terms of health third-party reimbursement. This was before COVID for telephone counseling and providers and clinicians, such as genetic counselors and oncologists and clinical geneticists, then started to do more telephone-based counseling, thus increasing access and reach of genetic services. Now there are a lot of digital kinds of interventions that are have and are being studied such as internet-based communications, websites, DVDs, other strategies. And many genetic testing companies are using chatbots and they haven't been studied and they haven't been studied in underserved populations. So I'll talk a little bit about our work in that area. And then using non-genetics providers to do some genetic education to help facilitate case identification and access to genetic services. So I'm going to talk about the GRACE project first. And so the GRACE project recruited women from three statewide cancer registries. I was living in New Mexico at the start of the study. So we were recruiting women from Colorado and Utah and using a cancer registry approach to identify them. And then we randomized them to three arms. They were breast and ovarian cancer survivors who had not had genetic counseling or testing and they could be getting care anywhere. So it wasn't in one integrated kind of health system where a lot of my research currently takes place. And they ranged in terms of years of diagnosis. We went back even 20 years and could ascertain them. And they were randomized to usual care, which is treatment as usual, targeted print intervention, public health approach, increasing awareness, education. So they received a mailed educational brochure about hereditary cancer genetic risk assessment and then information about cancer genetic services in their area. So we had tailored that targeted print for geographic areas. So there were links and phone numbers so they could access genetic services. And then the third arm got randomized to telephoto counseling and navigation. We used a multi-component tailored intervention. So we tailored the intervention according to the patient's health beliefs and their barriers to care. So the genetic counselors had a lot of information before they or it wasn't a genetic counselor actually was a decision coach, which I'll get to before they got to the educational session. And so then we sent the brochure in advance of the session and we sent some visual aids because good communication involves visual aids to enhance knowledge and hopefully comprehension of genetic information. Instead of using genetic counselors, we used trained decision coaches and the decision coaches were community health educators trained in motivational interviewing. For those of you who don't know what motivational interviewing is, it's a technique that uses a patient-centered approach to get patients thinking about the information that they give that are given to them so they can process the information. And the thought is that they are more likely to retain the information, think about the information and act on it. Motivational interviewing started with alcohol abuse and then tobacco. And then we've trained genetic counselors in another study that this study builds off of. And the genetic counselors, of course, initially were resistant. This is a theory-based intervention. Why do we have to do it? We use a fear management model. So it was theoretically guided where we raised awareness. We raised emotions because we know from a strong body of behavioral science literature that raising the level of emotion can get people to comprehend information. As long as you remedy that fear level with efficacy messages, there's something we can do about it. So we did a lot of barriers counseling, identifying barriers, and then helping patients overcome barriers. And that's why we added navigation to it. But in the prior study, which is a colorectal cancer screening genetic risk assessment study, the genetic counselors not only were resistant at first to the theory-based level of the intervention, but also using motivational interviewing. And they used to joke around how they were all female, but one, how they ended up using the motivational interviewing with their friends and their husbands to get them to do what they wanted them to do. So it is a motivational strategy that can be very effective that we implemented into this intervention. And so this is our fear management model. So we raise perceptions of risk and then response efficacy, the belief that genetic risk assessment can impact outcomes, and then self-efficacy. So the patient's belief or confidence in their ability to get genetic counseling and are testing. And that's where a lot of the barriers counseling comes in. So we manage fear, and the goal is to manage fear in a positive manner so that patients engage in protective motivation, which is to engage in preventive actions, take action, rather than defense motivation. And if you don't remedy fear messages with efficacy messages, that you're in danger of sending patients down this level of defensive motivation. So I mentioned we've recruited patients from two registries. In the middle of the trial, I moved back to my home state, New Jersey, for family reasons. And in Colorado and New Mexico, we targeted all patients, but we oversampled Hispanic and rural patients. So we had a large number of Hispanic patients.  So we weren't as effective in recruiting more Black patients, but that was our goal. But when you're a newbie on the block, you have to stand in line, even in research. And so we had patients met the NCCN criteria for testing. I don't expect you to read this, but patients were randomized to the three arms, as I mentioned. They completed a one-month assessment so we could assess mediating variables. Did we rate, was the intervention more effective than the targeted print or the usual care in raising risk perceptions, boosting self-efficacy, boosting response efficacy, and managing fear. And then they got a six-month assessment where we also did a survey, but we obtained genetic counseling and testing results and medically verified that. That was not an easy thing to do because this is a population-based study. We weren't in one integrated health system. And so we recruited 641 women and they were diverse in terms of ethnicity. And we had about 17 percent rural dwellers. And notably, most of the participants did not have a family history.  And so the primary outcome was at six months. We also did an assessment at 12 months where we removed the cost barrier. I'm not presenting that today, but if you're interested, the publication just came out in JNCI spectrum, I think, this month. And we did show an effect with a very low-intensity cost barrier intervention at a population level. So women in usual care, a very small percentage of women in usual care, and the targeted print got genetic counseling and or testing. And only 19 percent in the tailored counseling and navigation arm. And although we had an amazing odds ratio, so for those of you who look at or are interested in effect sizes, our odds ratio ranged from 7.4 to 8.9 depending on the comparison. So, for example, those in the tailored counseling and navigation arm were 8 times 8 point or 9 times as likely as those in the usual care arm to get genetic counseling and or testing. That's a huge odds ratio. But then if you look back, about 20 percent got counseling and or testing. We thought we could move the needle more. Interestingly, several of my colleagues have done studies in clinic settings using different types of interventions. It could be a DVD, it could be a health coaching kind of intervention. And they get about the same percentage of women or women and men, depending on the study, get counseling or testing. So it's really hard to move that needle. And so I think we need to find better ways to get more people tested. We're beyond making it sound like this is bad, this could be bad. And in the old days, when I started this research, it was very non-directive counseling. And so as you know, when most people go to the doctor, you take your parents to a doctor, grandparents, they want a little more direction from a provider. And that's where we've moved for the most part. What are the barriers? So lack of provider recommendation was the biggest barrier to genetic counseling, cost concerns, and then competing life concerns. And then genetic testing barriers were cost concerns, concerns about adverse psychological outcomes. And some people just don't want to know. There are people out there that don't want to know. So we have to respect that. And then in behavioral research, we like to understand the mechanisms underlying the effect of our intervention. I'm not going to go into a lot of detail with this, but we did a mediation analysis. So we wanted to see if our intervention did raise risk perceptions, self-efficacy, response efficacy, and knowledge of hereditary breast and ovarian cancer. And the intervention actually did impact these intermediate outcomes or mediators. This helps us to understand how this intervention worked, and then help us design future interventions. And that's published in Anals of Behavioral Medicine. And then I'm going to talk about some alternative care delivery models. So I just presented a population-based approach where we identified candidates for genetic counseling or testing at the population level. I didn't add a slide. We did look at the impact of the grace intervention on literacy level, ethnicity. We couldn't with race because we had too few Black persons, but we were very interested in that, and as you see my research moving forward. And the intervention, the tele-counseling intervention had the same effect across literacy level, years since diagnosis. It worked better for those who didn't have a family history, not surprisingly, because those learned more about the study and were informed that they may be at hereditary cancer risk. And Hispanic women actually responded a little bit better than non-Hispanic women. And we did offer the intervention in Espanol and Spanish. So we need alternative delivery models in clinical practice. So there's a complex interplay between lack of awareness, underestimating, underestimation of the personal and familial relevance of testing.  I only have sons. I don't need to be attested because they're not at risk. Obviously they are at risk. So there's a lot of misperceptions. There's low referral rates. Patients aren't being referred to the services. There's implicit bias and socio-cultural, individual, interpersonal level, and individual system level factors. So I mentioned the increased demand, decreased cost, with increasing genetic testing indications, decreased supply of professionals. So the standard approach of referral to pretest counseling is a common barrier. For patients who do get concerned, a minority of patients, maybe 20%, end up going to a genetics clinic. And the barrier is even more profound for Black cancer patients. We know that. The evidence, traditional comprehensive, educationally focused pretest counseling does not meet the needs of many survivors, cancer survivors, especially underserved minorities and those in lower socioeconomic strata. So we need new models of genome-based care that are responsive to community needs, improve access, don't overburden, scarce genetic counseling, clinical genetics resources, and do not widen existing disparities. So I was interested to learn about patients and community perceptions about using digital interventions to increase access to genetic services, increase awareness, empower patients, and for those who choose to get testing, get them testing, the care that they want. So we conducted focus groups of about 53 people. We did three focus groups with the mutation carriers. We did two focus groups with Black and Hispanic cancer patients, and then two additional focus groups with Black and Hispanic spouses and relatives. We've got lots of information, great discussion. Marlena this morning asked me about community-engaged research, how I got into it. I recommend it for everybody that's doing research and is not embedded in a community or with patients. If you don't do it, you're less likely to have an effective intervention and you're less likely to engage the communities that you intend to engage. So we learned a lot about family communication issues. We learned a lot about chatbots because we were interested in exploring chatbots, especially since genetic counseling companies, testing companies are using them. They're being used as navigators in health systems. Why not use it and test it, right? So there was an enthusiastic response to chatbots once we explain what a chatbot can do, but initially it's like, oh, chatbots from all the focus groups, because you call the bank and you're online and the chatbot doesn't respond to your questions, but then when they knew what it could do, they actually were like, wow, yeah, this could work. So there were privacy concerns, especially among Black community members, relatives of patients and patients. And so, of course, trust is a huge issue. And so we were reassured and a little bit surprised that Rutgers University was a trusted source, not only of information, and that they trusted Cancer Institute that we could manage their health information in a confidential manner. That probably comes from more community engagement. We started a community engagement outreach enterprise at the Cancer Institute about five years before, four years before these focus groups. So community engagement helps at many levels, not only your research, but for a variety of reasons, as many of you know. And so they gave us a lot of input into the chatbot features. You'll see some of those features. We got information about how to overcome barriers, including the trust, recognizing the historical treatment of Black Americans. All my, I get that input from all of my culturally racially focused interventions. They wanted to know what the benefits of testing were, which people often do, and they gave us some information about their preferences. And then the chatbot, some specifics about the chatbot, which you'll hear, we incorporate community input into the design of the interventions. And so we started building a non-culturally focused chatbot that first focuses on cancer patients. We can identify patients in the medical record, and this is called a catalyst study. So we used information from the focus groups for some of the studies I'm going to present moving forward. And so the chatbot has a menu of options, and then some are required. So the chatbot has some onboarding where patients watch a video. So they learn information, basic information, and then there's patient testimonials. Community members, patients, they love testimonials, especially if people, they can relate to the people that are in the videos. And then it can do a risk assessment. We're not using that for cancer patients, making it required, because the risk assessment asks a lot about family history. So our chatbot can create a family pedigree. So it's really cool. They love it. But the risk assessment can be quite lengthy, and we want patients to get the education. We want them to be able to ask questions, overcome any barriers, and those that want to get tested at the moment, the chatbot facilitates testing. They can upload their insurance cards. We work with our Life Center, which does our Genetic Counseling Center, and they will do some behind the scenes work getting insurance authorization. So we have a readiness ruler. Patients actually, most patients like this, when we've tested it, it asks about their readiness for genetic testing. Why is genetic testing important to you? Right? It gets them thinking. It uses a little motivational interview, and when we use health coaches, we use these rulers. Where are you in your decision to get testing? Oh, I'm thinking about it. Well, why are you... It's the rulers 1 to 10. Why are you this level and not this level? And then there's a little chat back and forth. So it really helps them process information. And then we send them an action letter, and their genetic testing results if they get tested, and a family communication letter, that they can share the results with their family members. They can choose whether or not to use a voice chat or not. So it's text or voice. You can change throughout the intervention. And this pilot study mirrors propel study, which I'll talk about the design. But this is just kind of what it looks like. We got community input into the messaging. We're ready to start the pilot trial for this, but we did a series of user usability testing. Patients generally say they like it, provide a very neutral information without being emotional, drama-free, to the point it allows patients to start without having to wait two months to see their doctor, who will then rush them through it or give the opposite response if you don't need that. It gives the patient a little more autonomy in decision-making and pursuing testing. They thought it was easy to navigate, used everyday language. I had a nice talk with Chris this morning about literacy and comprehension. So we worked really hard so that we understood how people thought about the messaging and the community input really helped a lot in that regard. I found online information that can get confusing and send you in 20 directions. You all Google, whenever I have a health problem, I Google and it sends me in 100 directions because I'm a researcher. And it's fairly simple information and helps make a decision. So we had numerous patients say, I'm wondering how long this platform is up and going? And if I wanted to refer family members, I was like, is it going to be ready tomorrow because I want my friends and family members to see this? So this is a culturally neutral intervention but we did find that in Black patients, we had so quite a few patients who made this comment on our community cancer action board when I was engaging in dialogue, not presenting, it's bi-directional with them. They said, wow, this reduces some of the bias I feel when I go to a clinic. I'm not sure how that doctor really views me. This removes that, makes me more comfortable. I don't have to deal with that anxiety, some of the symptoms of systemic racism. So I'm not going to read through these, but we had lots of great comments. And then we had applied for a Unite grant, which was a really cool grant. Mark Schwartz, a longtime friend and collaborator. Lucille Adams Campbell, friend. And now finally, we always said we have to work together. She's a co-investigator on this study. It's propel personalized oncology, promoting equity for Black lives. So this is a culturally tailored chatbot building on Catalyst. We did additional community engagement with Black providers, Black cancer patients, and relatives of cancer patients to adapt the Catalyst chatbot specifically for Black patients who suffer the most from disparities related to a lot of things. But in genetic testing, we're less likely to get a referral for clinical genetic services and are less likely to be tested for a variety of reasons, multi-level, like I showed you earlier. So the objective is to reduce disparities, empower patients by increasing awareness and access and uptake of testing. So the primary aim is to compare the efficacy of proactive outreach in the health system, which I'll get to in the next slide, plus streamlined genetic education and facilitated genetic testing through the chatbot. It's an AI, artificial intelligence-based relational agent. We now call, based on community input, and in change of this, we call it a decision assistant named GIDA, and we're comparing that to enhanced usual care on outcomes, engagement with genetic education and testing, genetic testing uptake, and cascade testing. And we're going to assess mediators, like that slide I showed you, the diagram of how the intervention worked or didn't work, and then explore other moderators of interventions, such as age, gender, type of cancer. So I mentioned what traceback was previously, so we're using a traceback approach. These are not newly diagnosed cancer patients. We're using clinical informatics. So we have a large integrated health system. At Rutgers, we just became integrated in the past few years with RWJ Barnabas Health. We have over 14 sites, lots of socioeconomic, racial, geographic diversity, and Mark and Lucille are collaborating, who you know, are collaborating, and we're recruiting patients from Georgetown MedStar. So we can go into, they use PowerChart. We use Epic. Epic is a little more facile. We use, if anybody's heard of DeepSix, it's a strategy you can program in the EHR. We can use those NCCN criteria I showed you earlier. We're recruiting patients with a variety of cancers. They're all black patients, self-identify. They have to have, you know, meet the criteria if they have breast, colorectal, pancreas, endometrial, ovarian, and prostate cancer. So with the expanded criteria, there are loads of patients out there who haven't been tested in our health system. So the expanded criteria makes more patients eligible. So we can identify the patients, and then we can provide proactive outreach and contact them. So we're using our health systems, community outreach and engagement throughout. We have a study-specific community advisory board that guides us along the way. Patients can then get genetic testing. They're in either arm. The approach is different, which I'll show you in a schematic. And then ideally, we're going to test at-risk. We're not testing at-risk relatives in this study. We're not funded to do that. I wish we were. I wish our grants were bigger because we could do this. And we want to develop a family portal. So when we did our focus groups, we talked a lot about how this family portal will work. So the patients' relatives, with the patient's permission, can access the chatbot or digital assistant and get the report, even get the report to the genetic information and watch the videos. And then if they want, if there's a pathogenic variant in the family, they can go through the whole process, the educational empowerment process, and get genetic testing. So we hope we can apply for a grant-gate funding to do this in a timely fashion. It's pretty sad how the NIH budget and other budgets are these days in worrisome. But we're tenacious, and we're going to try to make this happen. So who is eligible? This is a slide I crafted because I need to speak with all the physicians, surgical oncologists, radiation oncologists. So I've started doing that process, raising awareness about catalysts, which is starting at the same time. And this is a large NIH trial where we're creating close to 500 patients. And so patients need to be six or more months past their diagnosis, so they're not, for the most part, starting their cancer treatment. We're going to start identifying patients who've been seen in our healthcare settings, which are large, multiple sites, clinic sites, but all in our integrated health systems, and then go out two years because we're more likely to reach them, because addresses changes start to find patients. Then we have to go into lexis-nexis, search services, and that can be trying, especially with a limited budget. And so they have to meet current guidelines, and they cannot have a prior testing. So patients get complete three surveys, a baseline, survey one month, so we can assess for mediators, and then at six months. And then we do medical record abstraction, and then our genetic, because our chatbot facilitates testing, we know in that arm who got tested through our mechanism, but we have access to the electronic health records. And that, by the way, was no easy feat because you're dealing with lawyers at institutions, especially with the newly integrated health system in New Jersey, but we're patting ourselves on the back because we made it home. And so we can do more interventions and get more people the services that they need because they've been missed and underserved by the health system. So the patients get compensated, compensation is important, and then we give an extra bonus if they complete all three surveys, because when you do clinical trials, you'd like to get those of us don't like missing data. And they're, again, they get randomized to enhanced usual care. I didn't mention what usual care was. They get what the enhancement is. They receive those in that arm get a clinical letter. So they get a clinical letter from a medical oncologist at each site, Bonnie and Isaacs at Georgetown, MedStar, and then Debbie Topmeyer here in New Jersey. And the letter states that they are at increased risk, not in these terms, basically they meet the criteria for a genetic risk assessment and they're provided with information how to access it through the web or the phone. So it's a low intensity intervention, but they are informed of briefly informed about the risk from a medical professional. And we also tell them in the letter that their doctor supports the study. We know the doctor supports the study because to recruit the patients to the study, we identify them. We then send a letter with a list of potentially eligible patients to the physician. And then the oncologist needs to let us know whether or not to contact the patient. For example, patient could be in hospice, totally inappropriate. Patient could have dementia, oh no, totally inappropriate. So they do endorse the study. And then the patients who get GEDA or GEDA also get the clinical letter. But in the clinical letter, there's a link to the digital assistant, the chatbot. And then they can engage with the chatbot. And so this is a study schematic. We identify patients. We can send them, go through the process of physician kind of approval, randomize them. Patients can make a decision to choose genetic testing or decline. We used to call it relational system. I still have to change that. Digital assistant arm. If they don't have a pathogenic variant or mutation or have a variant of unknown significance, they can get the information about the test results from GEDA, the chatbot, who then will show a video of what the test results mean. And then there's some back and forth chat. So I mentioned it was artificial intelligence enabled. So we do have some questions, frequently asked questions that are structured questions. We provide the answers. Patients love that, because many of them tell us in the usability testing, we wouldn't have never thought about those questions. We love clicking on them, because you've given us ideas what questions to ask. And then we have the chatbot, which is open-ended questions. And it's using a structured knowledge base. So we provide the knowledge base. It's a generative model with credible information from credible sources. So it's not like chat GPT, where the chatbot is getting information just from anywhere. It could be misinformation. So that's how we avoid that concern. And then if the patients in both arms get a positive result, so pathogenic variant, then they're referred to a genetic counselor just close the results. We've had a lot of dialogues and disagreement. You know, with the Cures Act, patients have a right to their information. So some of us are proponents of giving the genetic test results via the chatbot. So I love your thoughts about that, versus having them to wait for a genetic counselor when we know that they can go to the lab, website, in V-Tay we're using, and get their genetic test results. So the other arm, the enhanced usual care, they need to get the results by the genetic counseling centers because that's standard practice. So that's another appointment. So one, free test genetic counseling. You already heard that's a barrier. And then post-test counseling. Can be done via telephone. They don't have to go to the clinic, telephone or televideo, telehealth. So these are just some pictures, snapshots I took of what Gita looks like. This is the top video. In the middle is the introductory video. Dana is the medical oncologist, and then the patient is wearing the purple turnip. The screen moves around, so you can see faces above, and they're having a conversation. So Dana is talking to the patient about hereditary cancer risk. It's an educational video and genetic testing. The benefits, et cetera. And then on the bottom, there's testimonials, patient testimonials. So we have patients with a variety of diseases and situations. And so those are very favorably reviewed as well. And then the chatbot. So there's questions in the middle on the right-hand side of the slide. Show the facts, the frequently asked questions that are pre-populated answers. And then this just has some more. We're asking the patient about their genetic testing decision, and then we guide them through the decision, whether if they want testing, then they're guided to upload their insurance card, or if they have difficulty digitally challenged. Most patients, even older patients, are able to use the chatbot. And so we do facilitate access to computers that patients don't have access to computers, but most people have digital phones and access to the web. So this can be used on a tablet, computer, or iPhone. And so you just get to see, like... And then patients love question prompts. And I have a nursing backgrounder who knew this, but they love when you give them questions to ask their doctor, because they didn't think about them. And so we gave them commonly asked questions and our community engagement approach helped us with that. And then they can write notes, put notes in there for other questions. And so we did usability testing. We just completed that. We're ready to start the trial in May. We have some revisions. So community engagement involves responding to community identified needs and suggestions. So it's an iterative process. So we just finished that. We're collating all the information and suggestions. And then we work with our vendor, which is a bot's crew. They've developed chatbots in other settings. And so they've been great to work with. So one male said, people knew about it, they would do the test. He didn't know about it. There's nothing I'm going to add to it. Jita did well. It's very understandable. The steps she takes you through. Very simple to navigate. This was something I enjoyed. I'm happy I did it. Like I said, it was very informative. It opened my eyes to things I didn't know, as far as I like testing. Another thing that was helpful was the questions that you guys listed in the PDF, that you would talk to your doctor. It would be great to take along. Just something to take to the doctor with you. About lots of feedback that they learned a lot. I like it. It's very self-explanatory, easy to follow. So they felt it was easy to navigate. We worked really hard on that. A lot of iterations related to that. Internally, even before we got to the usability testing, but then we got more input. My questions are being answered, and even some new questions I didn't think of are being answered. It really engulfs you into this opportunity to understand genetic testing. The chatbot has an ease to it. The time is in your hands, as to how fast you want to go. We heard that a lot. They like doing it at their own pace. They don't have to feel anxious at a clinic pushing information out in a busy clinic. And they like the family communication letter. They thought it was a great resource because they can just give it to their family members without figuring out how to tell them and explain the genetic test results. And see that's why the family portal would be so great, because then the family members, family, if one of them is tested, can refer the family members to the portal, and then they get the educational videos that are tailored to them, because they're not the cancer patient necessarily. Then I'm going to briefly mention Project Pinpoint. I know I'm out of time. I'll refer to your publication. I think it was this year in the journal Cancer. We were funded through an equity initiative by the American Cancer Society, who partnered with Pfizer Global Project Pinpoint, promoting informed approaches in precision oncology and immunotherapy. So when I moved to New Jersey, I started the Cancer Center's first community advisory board, which we call the Community Cancer Action Board. So we wanted action in there, because those of you know me like action. I'm just talking, although I like to talk a lot, as you can see. So Pinpoint addresses disparities in racial disparities. Black patients are less likely to get tumor sequencing of the tumor, guides precision oncology, which has been a game changer in oncology and cancer treatment. So molecularly targeted therapies and immune therapy can help more patients get into remission and survive longer, too early to look at cure rates at this point for long-term outcomes. So we know there's a suboptimal diversity in clinical trials. Minorities, black patients are underrepresented. Huge issue. We can't draw meaningful conclusions. When I wrote this grant, I wasn't surprised, because I'm in the disparities realm, that of all the molecularly targeted immune therapy trials we were looking at, very few black patients were in those trials. So we added a clinical trials module to this intervention, because many of these targeted therapies are being combined with immune therapy and other therapies. So that was important for this. So we know that black patients have higher cancer mortality rates, less likely to have tumor testing, wait longer for novel treatments and don't have access. Our CAB, Cancer Centerwide, identified racial disparities in access to novel cancer treatments and genetic testing as community-identified priorities. They told us. So we aim to use a community-engaged approach to co-create this digital intervention to empower patients and improve access to novel therapies. Molecularly targeted therapies. Again, you need to have tumor sequence to get to the level, to get the treatment. And then we did a lot of community engagement. We engaged with black providers, patients, cancer patients, and some significant others. Significant others are often involved in the treatment decision-making, so we wanted to get their opinions.  We hope to take this trial to a larger level, be speaking with one of the NCORP groups, the National Clinical Oncology Research Program, which is a cooperative clinical trials group. Most cancer patients get cancer treatment in community settings, not academic centers. And this allows patients to stay in their own communities and get access to clinical trials. Not only treatment, but trials such as this, cancer control trials. So I have a lot of some befores and afters. I don't have to show you, but we did a lot of maybe superficial tailoring, which is graphics and pictures. And then deep tailoring messaging. Iterative process along the way. We have a chatbot in this. The chatbot initially was optional, but in doing our usability testing was the most famous, one of the most favorite features of the chatbot. It wasn't AI enabled. We weren't funded, cost money. We were wanting to do the AI stuff, but it had pre-populated questions. And they really liked the interactivity, liked a lot about it. Clinical trials module, we got lots of input on messaging and how representation matters and how to say that, how to address distrust. We used some of the videos that I've used in other research and for our cancer center on clinical trials, focused on Black patients and community members since there's uni issues. And then we had a quiz and there are patients like the interactivity of the quiz because it broke up some of the text as you can imagine, complex information. Here's some of the videos from patients. Again, some of them are drawn on other community outreach or research projects. And then again, questions for your doctor. They love it, love, love, love. And then we provide a resource module. So in our Gita chatbot for genetic testing, and this we included resources because patients do like to be able to know where else to go without having to search a website and getting 20 to 100 resources that they can get through. Patients really, we had a lot of favorable feedback for the sake of time. I won't mention it. It's in the paper. We have a lot of exemplar quotes. They really appreciated addressing sensitive racial issues including acknowledging Tuskegee. That's important. We've learned that for clinical trials. Just enrollments. I work with the clinical trials office and my team. I have a great team. For messaging and activities to educate the public. So what did our research show? So our single arm trial showed that we increased knowledge about clinical trials and precision oncology. So we assess knowledge. Chris, I'd love to be meeting with you this morning thinking more about comprehension. We did have some knowledge questions. And then we increased decision-making capacity regarding tumor sequencing and precision oncology treatment. So we felt that community engagement really helped make this intervention a success for the target population. I'd like to acknowledge many people who were involved in all of this research. And I can take questions. Great. I will start out. I am really interested in some of the initial testing you did on the chat bot and whether you were seeing... I know it's not a lot of people but whether you see any patterns in whether folks use that chat bot differently or are interested in sort of gaining different things from those conversations or whether you'll be able to sort of look at that in the future. That's a great question. I don't think we can... We've analyzed the data for that purpose because we weren't set out to do. Then we have grants and we're on a timeline too. Be happy to talk to you later. We're meeting later about how to do that and maybe we could collaborate on that. I'm also curious with the chat bot and I know you're just starting out on the new project. But issues of difference by age and satisfaction with the chat bot. Yeah. So we're just starting now because the catalyst is in the pilot phase. That's culturally neutral and then the culturally tailored propel. We... With Pinpoint, we did see maybe older cancer... So there were older cancer patients who... And many... Most of those... I don't know if it was age or like poverty. Other issues. Literacy. I have to train my staff being a former clinician I knew. There are still people who can't read and write. And so there's myriad issues and it's hard to discern that in the settings. But we had some patients that... Just a few. Like maybe two come to mind where they had difficulty with the intervention. One, after probing my staff, I think the person had general literacy issues. The other had... Was older and had some difficulty using the Pinpoint chat because there was more going on. On there wasn't just a chat bot. It was an optional chat bot. But once they got into the chat bot, they could use that. And then in the usability testing, we just completed... Age didn't seem to matter. We... In the Pinpoint study, I had my staff help patients if they couldn't use the chat. But in this larger study, the Propel project, patients need to have some computer literacy to use it because that's what it's meant for, right? So we'll track that. Who is excluded and who has problems? My staff are trained or Mark's staff are trained to address questions, technical issues. But we're testing a digital intervention so if we include people where we have to send research staff, let's say NORC is one area, we have a lot of patients from underserved communities and my patients... My staff need to get on a train and get there and go there. It's not practical, right? Because that doesn't happen in the real world. So we refer them to libraries. We refer them to their significant others who can help kelp them through the chat. We have one male patient who was doing usability testing and he asked if his daughter could be with him at the time and so we allow for that because that can help them navigate the system. What do you think about giving positive genetic test results through the chatbot if patients can already access it? See, when patients access the genetic test results that they have a mutation of pathogenic variant on a genetic website all they get is the report whereas if they can get access it also through the chatbot if they choose they get a video that tells them what it means and what the next steps are. I know it's controversial but I'd love... If anybody has opinions you can email me if they're too shy to say because it's a controversial issue. Yes. So it feels like to me your main resistance may come from providers who have an interest in being part of that process. Genetic counselors or physicians as we've seen with... Yeah. Yeah. I actually have another question which is you are obviously very cancer-focused. Have you ever thought about adapting your tools here to different conditions? Because we talked about autism this morning and genetic testing that occurred to me that a number of what you're doing could be adapted to a different condition. Have you thought about those at all? Yeah. So not outside of cancer because I'm so focused on cancer but I'd be willing to collaborate with somebody who wants to adapt our tools for other conditions. For example, I have a lung cancer screening trial. So we're using... It's in Rutgers RWJ Barnabas Health System which includes over 80 clinic sites, primary care sites over 300 providers and millions of patients. And so we are identifying patients who are eligible for lung cancer screening. Relies on tobacco history. Tobacco history for determining eligibility for screening is poorly captured in the EHR. So we identify anybody who's a prior or past smoker and then our staff. I also have community navigators that do something similar for other screening. So it's really translatable that we have staff call them for eligibility because it's a research study and they ask them about their tobacco history so we can capture whether or not they're eligible and then they get randomized to two arms and the intervention arm is a decision coaching arm done by access navigators supervised by nurse navigators. In the health system I'll tell tell her hell. And that's a conversation with the navigator and then the patient if they want screening the navigator then helps them access screening. If a nodule is complicated lung cancer screening with the nodules and nodule clinics then they need to get diagnosis you know diagnostic workup or at least a workup up the nodule then the nurse navigator then intervenes because then it becomes like you know cancer workup and then navigates them to care. But a lot of the intervention I think could be done as we learn more about digital interventions and chatbots people like the conversation they like being able to ask questions they like the and they love the videos and testimonials a lot of it because we you know we we engage community they told us and this could be you know save the access navigator some time and maybe a little bit better because you know the access navigators vary in how they relay the information right because their navigators are not you know trained health coaches so I think we could the next step would be to take some of the stuff we're learning from the chatbot and use that to get more people screened not just for lung cancer and then have navigation behind the scenes are you interested in lung screening because we don't force test or genetic testing or anything on patients right it's a process and then if they they're interested then we send messages talk to your doctor but also then would have a navigator can we oh would you like to talk to somebody you know before you go to your doctor after and then we get the navigator to call so we could do that with other times of cancer screening we could do it with HPV vaccination especially you know training the younger generation on HPV vaccination we have a lot of work to do in that area as well yes I was wondering if you could expand more on the community research board that you is in New Jersey that you created kind of the recruitment process for that the training process and how you feel like having that community board is impacted the research you've done yeah it's not only the research I've done the beauty of it it's impacted my colleagues research so the community I have a study specific community advisory board for all of most of my trials especially working with underserved populations so that's study specific and then the community and they provide you know before the grants written they'll and then when the grant we get the grant intervention development we let them know what our community engagement research shows right the qualitative stuff and they're with us all the way in developing the intervention and evaluating community action board is Cancer Center Y so we're one of the most racially ethnically socioeconomically diverse states in the nation so we need to pay attention to representation and so we have a diverse board representing segments of the population they get onboarded they learn about you know the cancer center many of them are patient advocates they're interested because they are involved in cancer in some way they could be a like we like to have a you know primary care provider letting us know what some of the issues are in the the care world and then we have all walks of life socioeconomic status I don't want people that are the worried white wealthy well so we have I think good representation in our community would tell you we can't have a a hundred member advisory board right we started we grew it and there were about 36 members but that was a little too big so what we did was we have this board they provide input into the stretch cancer center wide strategic plan our community outreach logic model they provide input into initiatives it could be let's say a biospecimen initiative our human pathology resource we need to increase diversity so I bring them the leaders in and they get input from the community we're bringing researchers in right it's a researcher even basic scientists we've had to train our coach especially the basic scientists but a lot of my colleagues that are population scientists they throw up like GIS maps that are not understandable to the average person and you know gels and sequencing results so we have to coach them to talk in terms of you know the patients the lay patient can we also have to coach them in asking what questions they ask because the reason they're there is to engage in dialogue not to have a unilateral presentation it's a dialogue so that's that's been a hard concept actually to get across many scientists you probably aren't surprised and then that we that became really popular we don't have enough time at our cab meetings to bring everybody in who now wants to do it every every person who's met with our cab has said that was great I want to come back but they actually zoom in on the cab meetings then we started at Rutgers we were the first group to start a community a scientist program it was called citizen scientists at the time and then my friend and colleague Rob Wynn and I were at an airport we have a lot of deep conversations about disparities and other issues and he said one of one of one of his cab members they were they were good thinking about a citizen scientist program and he said well I'm not a citizen right I'm not a citizen of the United States can I can I be involved so you know that's morphed into community scientists so we train them we train we have a whole module that's spaced out over 15 weeks short self-paced there's some didactic that they come together and then they get hands on training they review our pilot grants so all of our cancer health equity center pilot grants are reviewed by scientists and then also community members and then now it's become so popular and even the basic scientists initiatives I'm trying to you know generate more disparities research in basic science are asking for community engagement so before they grants are submitted or when their grants are submitted they need a patient advocate we actually find them advocates so it's not just the board it's a lot of the board members have been trained as community scientists and then they lead what we have now is impact councils right because we can't grow 100 member board but people want to be involved so we'll take people who want to be involved regardless of who they are and they can choose what impact council the community scientists impact council so I'm thinking of starting a community scientist institute making it even more important right raise the bar a little bit so those are just some examples yeah thank you so much been great


No, of course, everyone look here please, everyone look here please, look at that, please, looking up, looking up, looking up, looking up. Everybody squeeze a little bit, you're super wide. Get in. Alright, everybody get back there. Take down his DS. Go ahead. Hold on, hold on, hold on, hold on. Let's see if we can have a box. Let's see if we can have a box. Let's see if we can have a box. That's a good one. Box. Box. So we're here at the display week. Here in Los Angeles. Going to do a whole bunch of videos about the latest display technology. Being shown by all these companies. Alright, that looks cool. So let's start doing some interviews around here. The ink looks cool. Let's check out the displays.