111 Daniel Petereit

>> I had a consent to have my talk videotaped, so I'll try to adhere to the consent form, all right? (laughter) Well, it's great to be back here. I know, for some of you, it's kind of different groups here. There's a group from the Cancer Center. Then there's a CDH group. It's been really a pleasure getting to know a lot of you over the years. Briefly about myself, I'm from South Dakota. I was in Madison from about 1990 to 1999. I did my training here. Then I was on staff. 

Then I relocated back to western South Dakota. I'll show you a map of where that's at, because that'll be one question, "Where are you from, again?" I got involved in the disparity project and ended up coming on staff again, so it's a real pleasure to be here. And I really want to thank Sarah, who's just been an absolutely wonderful partner on this project. I have enough material to take up two hours of your time. We can't go that long, but I realize that at 1:00, you probably need to start filtering out of here. As we go through this, I tend to speak a little too quickly, so slow me down if something doesn't make sense. I'm not going to go into too much detail on the cancer treatments. We can talk about that later. But again, it's a pleasure to be here. 

So we have a NIH funded project. It's called Walking Forward. That's the informal name. The formal name is Enhancing Participation In Clinical Trials For Native Americans. And if you go on the Reservations and say that, they'll look at you like, "What planet are you from?" So, we'll tell you how, with the derivatives of Walking Forward are. It's a product that basically addresses cancer disparities in the American Indians who live in western South Dakota. I'm going to describe this project called CDRP, you're going to hear me say it a number of times. That stands for Cancer Disparity Research Partnership. I'll discuss key elements of our program, and what are essentially five year results. 

I'll describe some new grants that we now have. And then when we go into the next grant cycle, which is probably 90% of the reason that I'm here, is to see if anybody wants to jump on board and collaborate in mutual areas of interest. So, the first question that comes up, where in the world are you from? Of course, Madison, Wisconsin, is the center of the universe, right there. And if you just get on I-90, and put your cruise control on for about 12 hours, you'll end up over where I live, which is what I like to call the UW West Clinic, and you'll see why as we go through this. Some people don't like for me to say that, but the reality is it's kind of UW West. As you get closer, Rapid City is located in the Badlands. So this isn't Fargo, North Dakota. If your image of the Dakotas is the movie Fargo, this ain't where I live, okay. It's kind of mountainous. 

It's very nice. Pardon my improper English, there. We are serving the three Reservations of western South Dakota, which is about anywhere from 60,000 to 100,000 American Indians, or Native Americans. I'll use those terms interchangeably. We have Pine Ridge down here. Rosebud. Eagle Butte or Cheyenne River. And if none of this geographically makes any sense, this little town called Sturgis, you should have some familiarity with that, because we get a lot of people that visit there later in the year. So what is CDRP? This is the program director. 

Rosemary Wong at the NCI. The program, this is a federally funded program. It was announced in 2001. The genesis of this is, after I trained here, after I was on staff, the chair here sent me an email and said, "Dan, you might want to check this out. This may be something that would be of interest to the population that you serve." So we put in for this grant. We were one of the first two sites to receive it. This is a pilot program for institutions that are essentially new to NCI clinical research. It's to focus on populations that experience cancer disparities. It's interesting that it was decided to put these into radiation oncology centers. 

That's another story. You needed to have a dedicated PI that was willing to take that on, which is yours truly. And then part of this was a mentoring education program called telesynergy. At one point that equipment was housed in this medical school and has been subsequently relocated. Then also a critical part of this was a patient navigation program. So here are the goals of this RFA when they were issued: increase minority access to and participation in cancer trials with those that have a radiation component; to increase the number of clinical and translational scientists studying cancer; really to develop new institutions and their ability to engage in long-term research efforts; and obviously to look at the problem of healthcare disparities. CDRP, that's just a repeat of that slide. The interesting thing about this funding mechanism, and this was a little bit political, traditionally the NCI funds, NCI designated cancer centers, such as yourself, and some of that money would trickle. Anyway, on this slide, traditionally the mechanism goes to cancer centers like this and then some of that money is funneled down to the communities. Here, it was the opposite relationship in that it was the community cancer centers that put in for the grant and then they would partner with an NCI designated cancer center. 

So what that means is the indirect money comes to Rapid City. And as you can imagine, there was a little bit of political maneuvering that had to take place for that to happen. The indirects went to us and then we partnered with the UW. Sorry, we got the indirects on this one. So we do provide, hopefully some benefit mutually. These are the sites that received them. So each one of these institutions have a partner with an academic center. Geographic distance really didn't really make-- It wasn't an issue. So we partnered with UW. Here are some other sites. 

We're working with a Native American population down in Texas. You can just read the list here. But each part of the country was working with a different population that suffered from cancer disparities. This is the NCI summary slide of how this is all supposed to work. Now the interesting thing is this is a big experiment. This has not been done before. There have been a lot of growing pains that have gone into this. And if anyone's interested in these slides, I have my cards up here. I'll be glad to make these available to anyone. But this is really the structure of how this is going to happen. 

If you've heard me speak before, I'm sorry, but you're going to have to look at pictures of my family. That's just part of the gig when I give talks. So, this summer. I have four kids between eight and about 14. They all want to come back to UW. So if you want an idea of what to do for your family vacation, if you've ever been to the Colorado Plateau. There's all these cool canyons along the Colorado River. I'm just going to show you some of those pictures. If you get one of those, you might as well stamp "tourist" on your forehead. But that's okay. 

(laughter) It's pretty hard to park that thing. That's my wife and four children. Last year, Sarah had a slide, too, but this year, she had to hold off on it. We were thinking about the cost of college. And so, we saw this little device and thought we'd try to reduce the number in our family. Just kidding. (laughter) Actually, I about had a heart attack. This just shoots them over the canyon. It's about 1500 feet down. But they survived it. 

I had these pains for a while. Okay, back to the subject. We'll do these little intermittent commercials, all right, just to see if you're awake. So, what is the issue? We know the data's out there that Native Americans, they have a very high instance of cancer. They also have a high instance of cancer mortality. The reports of the nation just came out on cancer a couple of weeks ago. I encourage you to pull that. But this just shows, in this particular slide, this is age adjusted for mortality. This is per 100,000 patients. 

It's 129 for all IHS, or Indian Health Service units versus 165 for U.S., all races. You look at that and say it looks like the cancer mortality is low. Actually, in the northern plains it's much higher. So there's a problem there. You're considered part of the northern plains area, it goes from Montana, as far west as Montana, and I think as far east as Illinois, in that region, or a little further. This is data from our own tumor registry. We have about ten publications, either having published or in press. These are two that describe the project. But what this shows is the stage of presentation for Native Americans walking in the door that are locally advanced. Native American versus non-Native, and we see there's obviously a disparity there. 

They're coming in with more advanced stages of disease. So again, this is a map of the area that we service. This is the population density. The population density is higher on the Reservation. So we have the three Reservations that we work with, as well as the urban population in Rapid City. So obviously, we need a hypothesis for all this. So as we were talking about this in 2001, one of the obvious issues here is distance. And if you put western South Dakota, you put it, actually in Wisconsin, you'd probably have about 30 cancer centers. Well, we have one within a huge geographic area. Could it be that distance from the cancer center is one of many barriers? 

Obviously, it's much more complex than that. So one of the ideas was to use innovative treatment regiments that actually were derived from the University of Wisconsin, implement them out there in that part of the country, often as part of a clinical trial, to at least address one issue of distance to the cancer center. So that's one part of the grant. This is the summary of what the grant does. We implement Phase II and III clinical trials. Some of these terms may be new, and that's okay, I can talk to you about them later. But brachytherapy is a form of radiation, where we can often shorten eight weeks of treatment down into, in some cases, one day. It's been used for over a century. Tomotherapy was invented here. It's also called intensity modulated radiotherapy. 

Again, if that goes over your head, that's okay. But it's a very sophisticated way of delivering radiation. We put together clinical trials with UW to shorten the overall treatment time. What I should've told you is a conventional course of radiation takes about two months. So not only is it a distance from the Reservation to Rapid City, it's an issue of you're dislodging them from their cultural roots for almost two months. So the idea was that if you use these innovative technologies, they're typically only available in universities and major academic centers, or metropolitan, you would at least provide state-of-the-art treatment to them, preferably in a clinical trial, you've reduced the overall treatment time and at least addressed one barrier. Obviously, it's much more complicated than that. We also have a lot of cooperative group trials that are run on a national level at all cancer institutes. And UW certainly participates in a lot of those trials, as well. So there's about 80-85 cancer treatment trials that we have. 

Probably the most important part of this program, if it succeeded, was our patient navigation program. And the patient navigation program is designed to help navigate patients through the complexity of their treatments. As part of that program, there's a huge social science component. And that's where CDH comes in, the school of public health, the medical anthropologist that we've been working with here. There's a genetic test that we're doing that looks at, is there a genetic reason that Natives appear to be more sensitive to the effects of therapeutic radiation versus non-Natives. So that's kind of the premise of this whole program. We put it together. The partner institutions on this, the NCI designated cancer centers, obviously UW. We needed a second partner, and it's Mayo Clinic. Judith Kaur is a Native American oncologist at Mayo. 

And then Linda Burhansstipanov, she has her own cancer program in Pine, Colorado. She's been a key partner with us as well. I should say the real partners are the ones that we're working with on a daily basis, are the Reservations. We're the phantom partner, they're the real partners. Just kidding. I'm being videotaped, so I have to behave myself here. So results. This is our patient navigation system. And these are two of the navigators. Actually three of the navigators are in Rapid City, Dave, Kevin and Mary. 

And then our other navigators live on the Reservation. These are people that are embedded in the community. They're Native American, and they know the system quite well, which also helps us get our protocols through. So, two navigation programs. One is the navigation program that exists at the cancer center. Their goal is to assist cancer patients with completing treatment. We do provide monetary assistance as part of the protocol. To date, we have "given out" about $220,000 over five years. That's what it takes to get these patients through, but it's about $1,000 per patient. Then there is the community navigation program and the other representatives. 

We call them CRRs, or Community Research Representatives. It's based on a model on the Reservation. They're called CHRs, Community Healthcare Representatives. They're out there to promote education, outreach, networking. And they do have some interaction with the cancer patients when they come back. Their objectives, we have a Cancer 101 module that they administer into the community. We'll talk about these surveys in a bit, as far as these surveys are trying to help identify what are some barriers to healthcare. There are patient navigation surveys. And they're really involved with networking. Because one of the complaints I hear about researchers, and I'm not exactly Native American, but I have an interest in this population. 

That's probably the reason I wanted to relocate back out there, was people come in and start "helicopter research." They do the work, they leave. They don't share the results with the community. And so, we'll get into how we have done what's called community based participatory research. So this really lays the foundation of trust for the entire project. Now, what the NCI wants to know every year, and we have to do annual reports, non-competitive renewal. How many people are you getting at a clinical trial? We'll get into that in a minute. But that's like the frosting on the cake. You can't get people on clinical trials unless you get them in the door, unless you get them early in their disease process. 

So usually every year, I come out here and give an update and get more ideas from you folks on how we should do this. but part of this was to write up the process, how are we doing this. There's about five papers, that have been written or have been accepted that describe this whole process. I'm a radiation oncologist. I wish I had an MPH, but I don't. That's another reason I come back here, because I need your expertise. And if I had time, I'd go back and get my MPH, but it isn't probably going to happen in the next year or two. That's another story. So this slide here depicts the number of contacts that our navigators have with patients as they go through treatment. It's in the order of around 50. 

So there are at least 50 interactions per patient as they go through treatment. In follow-up, it goes down to 21. That makes sense that the intensity, and you can't read those numbers, but it is a pretty intense interaction. Now this kind of summarizes a lot of things of our program. One, you can see the extensive support system in the background, in case you have a flat tire or something as you're driving up the Reservation. (light laughter) It's a joke, okay? This is Kevin, our navigator. He goes out there. He's head of all the navigators out there. He goes out there on almost a weekly basis. 

This slide, you can't see it in the back, but this lists the miles that our CRRs put on per year. So, in Pine Ridge, they put on 5,100 miles. In Rosebud, 5,700 miles. Then in Cheyenne Rivers, she's a real go-getter. She puts on about 11,000 miles per year. If you put in Kevin's mileage, our patient navigators put on their vehicles, about 25,000 mile a year. That's an enormous amount of outreach that's going on. So, at the end of five years, this grant is about a $5.4 million grant. That's a lot of money that NIH puts toward this project. Has there been any impact? 

Have we had any efficacy? I want to talk about the impact on patient navigation. Has there been a reduction in treatment interruptions? Has the overall experience for Natives been enhanced? Has there been any change in trust toward the healthcare system? This is an article that Sarah put on your Web site, as well. We wrote this in conjunction with UW and CDH, but it was basically going through what's called cultural competency. There's been a lot of cultural incompetency that's happened. But again, trying to get into this issue of-- I'm sorry, you can laugh here, but it's true. A lot of people come in. 

They think they can come in and do this research. It just doesn't happen. But it at least describes our experience. This is a research that I was involved with when I was at the University of Wisconsin. My initial area of research was in cervical cancer and a lot of brachytherapy. Cervical cancer, and head and neck cancer are two treatment sites that we know, that if you give them a week off during the middle of their treatment, their cure rate goes down by about seven to ten percent. So it's important that once someone starts their cancer treatment, they need to complete it in a timely fashion for certain tumor sites. This is just some data that we generated back in the '90s. So that's why it's important that for certain tumor sites, head and neck, cervix, and a few others, once you start, you need to complete. So what this is showing, and this isn't a randomized trial, but the control group are Natives who went through treatment who weren't navigated versus those who were navigated. 

And there's been a reduction in treatment breaks by at least three to four days, which can actually make an impact in someone's cure rate. So that's at least one piece of the puzzle. This is going to come out in two articles in the Journal. This is a disparity article that's coming out next summer. I would be happy to provide any of this information to you. This survey, when you put this grant together, there was two surveys that we wanted to administer. One is a community survey to identify and document the barriers to timely and effective cancer screening, diagnosis and treatment. This was a 1,000-participant survey that was administered one-on-one. We had to go through focus groups. We had to go through training. 

Right now, the article is about there. Rebecca, raise your hand, she's been working intimately with this project. She helped put this together. I'm going to share some of that data with you. The other one that we have is a cancer patient survey. And the basic hypothesis is, do Natives who walk in with early stages of cancer have a different set of attitudes and beliefs towards cancer than those who come in with metastatic disease. Case in point, we do a lot of talk shows. We're out in the community. I'm down about three hours away Rapid City. If you think Rapid City is isolated, you should go out to the Reservation. 

So we goon the radio and do this little talk show. It takes about a tank of gas to get out there. Probably because everybody drives trucks, but that's another issue. So, it probably wouldn't go over well in Madison, but that's just the way it is. So, I'm filling up my gas tank and this guy looks at me and goes, "Oh, yeah, you're that cancer doctor that was talking on the radio." He says, "It doesn't matter if you get cancer, you're going to die anyway." Well, if that's your attitude, you're not going to go in for a PSA. It kind of illustrates what we're trying to get across. Now we have a co-PI, her name is Ashleigh Guadagnolo. She's a Native American radiation oncologist who was trained at Harvard. 

She's now at Indiana. She helped put this together during her research. The goal of the cancer survey is a hypothesis testing instrument designed to determine root causes of cancer differences and cancer related outcomes among Natives and non-Natives. So what we're doing is surveying, I think it's 150 Natives and 150 non-Natives. And we at least want to go through some preliminary data. Multiple scales were developed through modification of existing scales and literature and Native American participation to develop a cultural appropriateness and engagement. The content and validity is verified through focus groups. Again, UW is very instrumental in helping put these together. There was good internal consistency of these scales, so they think it's one that's at least a valid measure. So this is based on 52 Natives and then a 113 non-Natives. 

There was, I'll just read from the slides here. Native Americans expressed significantly higher levels of mistrust and lower levels of satisfaction with the healthcare system. In multivariable analyses, race was the only factor found to be significantly predictive of higher mistrust and lower satisfaction of the healthcare, even when adjusting for income, education and geographic remoteness. This article has been written. It's been submitted for review. I hope it's going to be accepted. The same data set, now looking at another set of questions, assessing knowledge and attitudes. This is, I think, quite interesting. And Natives scored lower on screening knowledge, battery and exhibited more negative attitudes about cancer treatment than non-Natives. And again, in multivariable analyses, Native American was the only factor found to be significantly predictive for lower screening knowledge and more negative attitudes about cancer treatment. 

That's the subject of the second manuscript. There's a persistent stage disparity. Natives in this particular data set, again, presented with more advanced, and this is important, presented with more advanced stage that were screen detectable cancers than non-Natives. For example, breast, cervical, colorectal and prostate cancer, they weren't diagnosed as part of the screening test. Patients with a screen detectable cancer, the identifying diagnostic test was about 70% for white versus about 40% for Natives. Again, consistent with what you would think, that they're not going in to get screened. Implications. Stage disparity shows continued barriers to timely and effective cancer care. Mistrust and less satisfaction with prior healthcare emphasizes the need for patient navigation. Less screening knowledge and more negative attitudes toward cancer emphasizes the need for educational interventions. 

And as we go through this, just stop me, because I'm going to go through a lot of data, if there are some things that you want to comment on. One of the things that we can't get our hands on, is what is the screening rate out there. It just doesn't exist. We've gone to the Reservations, talked about looking at charts. That data, unless somebody knows it in the room here, if you do, let me know later. We'd sure like to know what it is. We've now completed all the surveys for the initial 900. Rebecca, she's the one who mined the data for this, these are what the screening rates are. For breast cancer, 61%. Cervix, 49%. 

Colorectal, very low for females and males. And prostate cancer, only 32%. This is now again from the community survey, Natives indicated they were more likely to get screened if: a screening advocate made a public presentation; if a screening clinic came to their community; if they knew more about screening; if they had help with transportation; if they had help making appointments. And 53% of the males and 70% of the females planned on obtaining cancer screening after the survey was administered. One of the dilemmas here, we went the tribes and we'll talk about how we were able to consent the Lakota Nation to participate in this. The comment stated to us was, "You know, we're tired of you guys coming in and asking the same stupid questions." And our response to that was we understand that. We're trying to identify barriers. But not only are we trying to identify barriers, we're doing something about it. We're providing money for food, transportation and lodging. 

We're providing state-of-the-art cancer care. And if we can, with a positive peabody, show that it's really about food, transportation and lodging, or that's one of the issues, then maybe we can go out-- ACS, raise your hands, because I'm working with these guys, the American Cancer Society. We can't speak in full words in oncology, just like the military. What's that guy talking about? Maybe that would be enough justification to put some type of help lodge together. So, that's what we tell them. We want to do something. We want to take this information that will lead to an intervention. Okay, Shannon, raise your hand. Shannon Sparks, CDH, a medical anthropologist. 

I have a lot of background in this, right? That's why I'm working with you guys. So we asked her to go back and take a look at the community survey, and to say can you find out for us, is there anything in there that would say something about, you know, subjective inpoints, like trust and missatisfaction. And so, I'm just going to go through some of the data that Shannon has put together for us. So, three open-ended questions in the community survey. You can read them up there. We'll just go through the data that she was able to generate. Initial review of the data showed two primary categories of barriers to accessing care. Structural barriers, lack of transportation, money, child care, accommodations, insurance. And then there were barriers within the healthcare system. 

We're talking about Indian Health Service, service access, unable to get needed referrals, delays in getting and receiving care, quality of treatment delivery, clinical interactions. It is our subjective experience that when you work with this population that that's what's going on. And there are a lot of delays. And part of what we're supposed to do, which isn't popular, is to document what those delays are. There are the delays of the patient having a symptom to actually seeing a physician. That's delay one. There's a delay of seeing a physician to actually getting a diagnosis. That's delay two. Then there's the delay of having the diagnosis and seeing a cancer specialist. And sometimes that delay is a year. 

Sometimes it's two years. So you wonder, gee this is why they come in here with incurable metastatic disease. We're not here to point fingers, but we're here to try to point some issues out so we can help resolve them. One-third of the respondents reported problems accessing needed healthcare. The most common complaints, again, some of this we've gone through. Can't get needed referrals, transportation, not enough doctors. I mean, it's no surprise that someone who trained in Boston or New York, and they had their medical school paid for through that program, they probably don't want to spend ten years in Pine Ridge. They're doing their six months and getting out of there. I don't think it's as bad as going to Iraq, but you know, there's a turnover. And the people that are there the most consistently are going to be probably the physician extenders, the nurses, case managers, folks of that nature. 

Okay, so has there been an impact in patient navigation and a reduction of treatment interruptions? It would appear so. Has the overall experience during treatment been enhanced? We are now administering pre- and post-patient navigation surveys, 230 Natives have undergone navigation. This is a little bit like asking me do I love my mother. Well, of course I do. It is the experience of the cancer center staff that patient navigators have greatly enhanced the overall process for Natives undergoing cancer treatment. Completion rates, satisfactions, attitudes, etc. I'll give you an example. Head and neck cancer is one of those that it's really tough treatment to get through. 

Patients have seven weeks of radiation and chemotherapy. They need feeding tubes. If they take a week off from treatment, their cure rate probably goes down by seven to ten percent. Our navigators latch on to these patients. They'll go to their hotel room. They'll check on them. They'll drive them back. It's a phenomenal undertaking to get them through their treatment. Okay, I'm going to break here. During this little excursion to the southwest, this is Valley of the Gods. 

If you've been down there, this is a cool area. You can see the four-lane interstate there. That looks like a good idea to put a 30-foot motor home on, but you know, I wanted to see this. I don't know if you ever saw that movie, "Vacation" with Chevy Chase when he goes cruising off there. We were close to it. We came up on this river bed. The road got washed out. And I went out there. I measured how long our vehicle is, and I'm thinking I can really do this. We can get through this. 

(laughter) My kids are just looking like, dad you've got to back up. So there's a lot of Europeans that were touring at that time. And one of these little vans kind of got stuck and we pushed them out. So, okay, I'll back up. And we got out of there. So that's as close as we got to the Valley of the Gods, halfway through. And this IHS there, that actually stands for International Hockey School. My kids are all into hockey. I kind of like that. All right. 

Now going to clinical trials. Breast cancer, we have, and hopefully this is common knowledge. But a woman with breast cancer can either have a mastectomy or a lumpectomy followed by six weeks of radiation. There's been tens of thousands of patients that have gone to clinical trials. We know those are equivalent as far as their outcomes. Western South Dakota, unfortunately and historically, has had some of the highest mastectomy rates in the nation for all races, it doesn't matter, you know, what your background is. One of the reasons is probably distance from the cancer center. So some of the issues that the Natives have, I would argue, a lot of other rural population has as well. And we have it in Wisconsin. That relocating to Rapid City or UW, although there are a lot of clinics around the state here, is a contraindication. 

It prevents them from going through breast preservation. Brachytherapy, this is a linear accelerator. This is what we use to treat cancer. I know you're not all cancer physicians. But that's the type of machine that's used to treat patients for six weeks. It's painless. It doesn't hurt. That's the standard approach. This is an approach that was actually really pioneered here and perfected. Breast brachytherapy, one of the reasons I still keep my privileges here, so if I need to, I can come back. 

Because I wasn't trained to do this when I was on staff. But I came back to get trained, to do both of these techniques. I'm sure there are radiology oncologists in the back. Raise your hands. You guys all know who each other are. The guys in the white coats are radiation oncologists. (laughter) They're the good guys. They're the Cavalry. Just kidding. So, what this does, is it reduces your treatment to five days if you're a candidate. 

So, this is a very important clinical trial that we wanted to offer. If women were eligible, without going into all the details, they could have five days of radiation instead of six weeks. They had to be relatively early stage breast cancer to have it done, but the technique was perfected here. The staff of UW came out there to make sure that we're doing things properly. These are major interventions. You don't put 20-30 catheters in someone's breast-- And I didn't go through the whole treatment here. What happens is this little balloon that comes out of the woman's breast, or these catheters, is hooked up to a little robot that has a radioactive isotope that travels out of that machine down a cable. Then it spends around ten to 15 minutes, either in this balloon or in various portions of these catheters. They just deliver radiation to that part. I knew there'd be non-physicians here, so I didn't have a lot of clinical pictures. 

I didn't want to scare you. But it's actually pretty well tolerated. So we have probably done about 40-45 patients this way. We try to do a lot of this on clinical trial. It's been tolerated very well, for the most part. This is an interesting program. ACS, raise your hands again. You were instrumental in helping out with this program. This is the breast-- We're introducing you guys so you know who you are. So the breast and cervical screening program. 

What it is, it's a federal program, that if a woman, regardless of race is below a certain income level, then she's a candidate for having screening for breast cancer or cervical cancer. So if you now imagine that we have our navigators out in the Reservation. They're promoting screening. A woman goes in, she gets screened on a Reservation. Hopefully she doesn't have cancer, but if she does, hopefully it's early stage and if she wants, she can have breast brachytherapy and be done with her treatment in five days instead of six weeks. So that kind of nicely closes the loop in how this would work. The other thing that's nice about this program, at least in South Dakota, if you're diagnosed with cancer in this program, your cancer care is paid for, independent of Indian Health Service funds. That's huge. Because there's a limited pot of money for Indian Health Service. So it's another way to get through the treatment and get it paid for. 

Prostate cancer, there's a lot of treatment options for prostate cancer. Just so you don't think we just pick on females, we picked on males as well. This is another form of brachytherapy. It looks a little bit brutal, but patients don't feel any of this. They're asleep when it's done. But what we do is we put little seeds into the prostate gland. They stay in there forever. It's one treatment. If they're early stage prostate cancer, cure rates are 90-95%. They go home the same day. 

Unfortunately, a lot of what we see isn't early stage prostate cancer. We see more locally advanced. So one of the protocols we have requires, instead of five weeks of radiation, we do it in three weeks. And then we do a different type of brachytherapy to complete their radiation. We don't do as much of that because of Tomotherapy. And credits to UW. You guys have just led the way in so many things. And one of the things I've said before when I give these talks is what's called the Wisconsin model. The Wisconsin model is you have all this great technology here. But are you going to implement it in the community and who's going to do it. 

And here's an example of the Wisconsin model. A gentleman on staff here went back to the drawing board and tried to figure out the best way to treat radiation from the outside. Just because of the interest of time, I'm not going to go into all the details. But this is a non-invasive way of delivering radiation. And because of it's conformality, or how precise it is, you can reduce eight weeks of radiation, in some instances, down to two or three weeks. So the clinical trial that we had, this has been the most successful trial that we opened in Rapid City. It's a collaboration with UW and a few other universities. It's kind of funny to see our name below all these other big guns, but that's all right. What it is, it condenses radiation to the prostate down from 38 treatments, to 22, to 16, to 12. And when you reduce the number of treatments, you increase the dose. 

The reason that we can get away with it is because of the precision of how this technology is delivered. I just presented this data in LA about two weeks ago. There's been 270 patients that have been entered in this trial. We've entered 40 ourselves. We have not seen any bad toxicities. So that's another great study, great technology they're implementing as part of the clinical trial to increase access to quality healthcare. So this is a radiation sunburn. That's a bad side effect that we don't want to see, but sometimes we do see it. And part of this project was, it was the anecdotal experience of physicians treating Natives in that part of the country, that they seemed to have more intense radiation reactions. And why is that? 

Well, it's a complex question. There's a gene called ATM. So the idea was, could we correlate ATM heterozygosity to the development of a radiation side effect? So, you know, in the nice ivory tower of UW, I'm not picking on you, that sounds like a great question to ask. When you think about it, you're going to do a genetic test on the minority population and you're a white radiation oncologist. That may not go over very well. So it took about three years before we even introduced that concept. But once we introduced that concept, and we got the trust of the tribes, it was an easy thing to recruit. We draw the blood, 100 Natives, 100 non-Natives, and we send it to UW where Amy, I met with her this morning, she's a PhD basic scientist in the Department of Human Oncology. They sequence the genes. 

So far, they've done about 40 Natives. And I think we're approaching 80-85 non-Natives. So the data to date on this-- So again, what we want to do, in the future, this is what cancer is probably going to be. You biopsy the tumor, like say for breast cancer. You determine what type of breast cancer it is. Is it going to respond to hormones? Is it going to respond to chemo? So that's going to be tumor related treatment. Well, you also have the host. And how do you protect the host? 

Well, there's now data I'm going to share with you that can tell who's going to be more susceptible to, in this case, a radiation reaction. So if you did a biopsy of a normal tissue, or a blood test in this case, if you find out this patient is going to be more susceptible to a side effect, it would alter your treatment. So to date, this is an enormous undertaking. I have my notes here, so I'll have to just wing it, because I don't sequence the gene. But what they have done is they have sequenced, I think, about 5300 axons. They have complete data on half of these patients. We haven't broken the code yet, but 11 variants have been identified that would result in an amino acid change. This is pending publication as far as how do we do this in this community to get their trust in order to implement this protocol. These are the variants that have the amino acids change. This is the most common variant identified down here. 

What we don't know, are these patients, is this genotypic change going to result in phenotypic expression. We don't have a test to see if this protein is or isn't going to be non-functional. In this case, meaning that it wouldn't repair the radiation side effect. The surrogate marker is going to be the development of acute radiation toxicity. We'll break the code eventually. But we've been very successful in doing this study. So as of 2004, even though we started in 2002, these are the number of patients, Native Americans, that have gone on studies. Six of our own, it's actually higher now; 13 in cooperative group trials; it's now 31 for ATM; patient navigation is 227; cancer survey is 66; general survey now 1,000. We now have entered nearly 1,500 American Indians on IRB approved protocols. Now, a lot of that is social science research, which the NCI views as equally and critically as important. 

So we're getting there. Now, the good news or bad news is the NCI said to us, we want you to go back and look at your population in western South Dakota. And see if there's any other populations that are underserved. We'll use the term underserved. So each county has what's called an IMU, or an index of medically underserved score. It turns out that everyone who lives in western South Dakota is medically underserved. So now we can count everybody, from NCI's perspective. That's good news in the grant perspective. That's bad news if you live out there. But it isn't that bad. 

But I guess I'm considered underserved, too. So, if you now pool everybody together, that's gone on these trials, because part of the pitch to the community is that not only is this for the Native American population, it's for everybody. We have nearly 2,000 participants that have gone on various studies of Walking Forward. That shows the same data set. Community based participatory research. This is a slide I got from someone from IHS about a week ago, going through, what is it that researchers need to do to implement research in various Reservations. And a lot of this has been written up. We've written it up from our own perspective. I'm not going to read this to you. We can go through that a little bit. 

It's going to be different for each investigator that goes in. But there are certain common themes. Now, one thing that we have done is when the Tomotherapy was implemented. This is a medicine man. What we've done is we've actually partnered with the medicine men, where we don't think that western medicine and Native American healers are mutually exclusive. So we work with them, actually. This guy came out and did a blessing of the Tomotherapy machine. We will get direct referrals from the medicine men, who will tell their patients you now need to go and see the cancer physicians up in Rapid City. Our head navigator is actually a medicine man, as well. So that helps when you have people in the community. 

I show this slide partly out of amusement, but if you have a protocol in Madison and you want to implement it. Basically, you write it up. You send it to your IRB and you start accruing patients or asking the question. So we had to go, for each protocol, there's like 12 now. We had to go to each Reservation, to each tribal health council and get a letter. There's actually seven letters when you add them all up. Then we had to go to the a local IRB. Then we had to go to the national IRB. Then we go to UW's IRB. Then we go to our own IRB. 

So, our project manager did this for me. This is just one protocol. This is just the timeline. You get the trend here. This is why it took about 18 months. Our patient navigation-- I can see you all shaking your head. You're right. It is possible. (laughter) You don't have to be a glutton for punishment. But part of it is paying your dues. 

So that's part of this whole community based participatory research. They know who we are now. And that we're not going to just disappear. I'm going to talk a little bit about clinical trials. Why some of our trials have been successful. One is patient convenience. You know, you're not going to sacrifice care for the sake of convenience. But some of these treatments, if they're more convenient, and if they have side effects that are the same or less, then that's very acceptable for this population. MD considerations, they have to fit into community standards. Community based participatory research, CBRP, I'll give you a couple examples of that. 

Now, one of the things that we've done is looked at, for everyone who's been navigated, what percentage of patients went on clinical trial and who didn't. We're also including ATM as a trial. There were 21% of the patients who underwent patient navigation were enrolled under clinical trial. That number is historically less than one percent. Now, the really important question is why do patients not go in clinical trials. We've looked at this for both the Natives and non-Natives. And the overwhelming theme is metastatic disease, advanced stages of disease, or poor performance status. If somebody comes in with metastatic prostate, breast or lung cancer, it's too late. I mean, we can help them, but do we switch into a palliative mode. That's a little commercial break. 

This is at Bryce Canyon. These are my goofy kids. They were getting tired of having their picture taken. It was pretty funny. My wife would say, "Line-up," and they would get into this formation. She did this one time and a Marine walked by. He just thought that was the funniest thing. (laughter) This is Arches National Park. If you ever have time to spend a week in the national parks down there, it's just unbelievable. So, this is now where UW comes back in the fold again. 

If it's going to be a matter of getting people in earlier in the disease process, we need more primary care physicians involved, and probably not radiation oncologists. So, what we wanted to do is implement the same thing for men that the women have, which is the program. We put together this program called, All Men Count, which was sponsored by UW and Spirit of Eagles. So what we did, with Lisa, raise your hand, and Kathleen. These two, with Shannon and Sarah, they helped put together this program. What we did, is we drove out. We put this together. You would think doing a cancer screening clinic would be an easy thing to put together. It actually took about ten months to fund this whole thing. Spirit of Eagles helped tremendously, with Kathleen's research. 

Kathleen spent a couple months with us. What we wanted to do is the first step in screening, get men in for their prostate screening and colorectal. Here's the drive on the way out. There's a number of things to notice. One is, you see the four-lane interstate. Okay, you don't see that. Two, like Kevin's slide, there's really no McDonald's around or any gas stations. And three, you see this ominous storm that we were driving into. But fortunately we were able to turn around and go the other way. We got there. 

That's our planning station, as we were putting this all together. There was an intake survey. There was a survey to take afterward. So there was some data we were talking about getting analyzed. I like this slide. I have no idea what this discussion was. But this is Kathleen. She's kind of embarrassed. I'm sorry, Kathleen. I have no idea what these two are talking about, but I just kind of thought that was a funny slide. 

There's something on her boots, but I'm just going to leave it up to you. You were patient. You were persistent. You hung in there all day long. I like this picture of Lisa. This is Kevin, our navigator. I'm not sure why he's laughing so hard. I'll leave it up to your imagination. It was a fun day. It was a rewarding day. 

I think it was Lisa who said to me, in all seriousness, one of the patients said, you know, I can't believe Dr. Petereit would bring all these people here just for us. That's really all it took. And so, these are patients that are obviously very underserved. That's why we're doing it. So it was very gratifying to have done that clinic. This is what used to exist in Madison, this expensive piece of telesynergy. But the reality is this is a pretty rich institution, so your institution probably didn't need another piece of telemedicine. It was being underutilized between ourselves and Madison. We have one. 

You have one. But because I trained here, I'm on staff here, I need some hands-on experience. I'll just come back here. It was underutilized. So the NCI said to us, either start using it more or redeploy it. So after considering all the options, we redeployed it to Pine Ridge. So that system went from here to Pine Ridge. The ultimate goal is to hopefully improve access to healthcare. So the next grant. I know you probably can't see this in the back, but we're going to stay strong in clinical trials. 

That's what I'm trained to do. We're going to get more involved in genomics. We spoke about that briefly. Discuss patient navigation. We need to expand that program. We really need to get into screening education. And then palliation is basically non-existent. That's an area that's really needed. This is kind of a neat story. This technology is now here, if you let me digress for a moment. 

Right now, we're looking at one gene to determine whether or not there's a correlation between that and a radiation side effect. Well, the technology now exists where we can take a patient's blood, lymphocytes, characterize the DNA, the whole genome, the DNA microarrays and signatures, radiate the lymphocytes twice in the lab and repeat it. So there you would get a whole picture of their genome. So what we have done, we put in a protocol that was funded through UW, and we've identified 20 Natives, ten with complications and ten without. And we want to go through this whole process. It's a small step, but hopefully it's going to help in further characterizing how to better treat the cancers. This is important. If we do identify a patient that has a molecular profile that looks like they're more sensitive to radiation, you probably don't want to give them 12 large fractions of external beam, as opposed to 38. Maybe they're a better candidate for brachytherapy. Maybe they're a better candidate for surgery, but it is going to help. 

This was just funded. This was an interim funding from the NCI because our grant officially expired 9-1-07. So when I came back here last year, I said, guys, we've got to start thinking about what we're going to do here. The NCI knew that our funding was going to cease two months ago. So when we put in a screening supplement last spring, it was funded. The whole goal was to basically increase screening rates by 20% for this population. What it is, in essence, and that's a good cast to do it in 12 months, we're not going to increase the screening rates for everybody. But for the target population, what this consists of is we now have real extensive training going on for our CRRs or Community Research Representatives. They're going to be leading focus groups. Focus groups first. 

But they'll administer these education modules. The endpoint is going to be, how many of those patients go for cancer screening. It is admittedly a small step, but it's what's required. We're going to be using what's called these ARS systems, or Audio Response Systems. So that's another project in itself. But I want to discuss that with many of you tomorrow as we set up meetings. So has there been success with the program? We think probably the biggest that we've done is implemented-- There's two things. One is, implementing a research infrastructure in the community hospital setting. This was a growing pain for the NCI. 

Every one of these community hospitals-- I was probably the only PI that had any academic background because I was on staff here for five years. All these other communities, it totally stressed their hospital administration. I can tell you it totally stressed our hospital administration. But they got over it. But that was a hurdle and a barrier in itself. Then there was the barrier of just getting the trust of this population. We can't rush this. It takes a lot to get the trust of this community. But what we think we have done is built the infrastructure and trust that allows for future research to take place. So if you have a protocol, if you have an idea, you want to work with us on it. 

We think that we have system in place to where we can successfully implement it. I talked a little bit about what we think are some early measures of success for our patient navigation program. I wish I could say, I think someone was here a year ago or so, that they were able to be show there's been a stage migration for breast cancer patients. That's not going to happen on this project for another five years. You've got to implement the groundwork first and then hopefully you get into screening and you have patients presenting earlier in their disease process. Okay, our next grant. Why continue? This is 90% of why I'm here today. Has this been mutually beneficial between our institution and yours? We've been approached by other universities. 

But from our perspective, UW is clearly the most logical choice. We need to build on the experience of the past five years. Again, we put this infrastructure in place, like this genomic study. It's easier to now implement that since we did the ATM study. We want to continue with these innovative treatments trials. A big part of this is, I don't have an MPH. I'm not a social scientist. I know my limitations. But I know a lot of people, that's your expertise. And so, in the last year, there's been a dialogue going on with Sarah and her group. 

Maureen will be meeting with a lot of you soon. I always tell people, you know, if this doesn't work, I understand. Because you need to be able to justify to the taxpayers in Wisconsin why you're working with this guy in South Dakota. Aren't there Native Americans in Wisconsin? So one of the ideas would be if you felt that this has been a useful model to look at, maybe it's something that you can do it in Wisconsin. We need areas for more screening and education. We desperately need help with hospice and palliation. And again, maybe some of the lessons that we've learned out there can be applied to this area. This is a slide from my staff. I'm going to have a captive audience. 

I said, tell me what you want me to communicate to them. I'm going to read through it. This will give you an idea of what we can talk about in the next few days. So for our training, can UW develop a training program for our CRRs, to be able to become confident in interviewing and recruiting patients and when conducting follow up for screening tests? Tracking Tools. Can UW develop tracking tools for the different strategies we try in each community, in terms of tracking and documenting the screening navigation program? Qualitative data analysis. Here are the data sets we have. Patient navigation. We have qualitative data from summaries. 

There's all sorts of databases there that need to be mined. Palliation. We don't have any program in place right now. I know Spirit of Eagles has a program called Train the Trainer. Train the IHS physician. But it might be more appropriate to train the physician extender, because the physicians are only there for about six to 12 months. So, other areas of collaboration. I've spoken to many of you about this. There's a whole telemedicine aspect. We have a lot of money that can be put into that Reservation, $350,000 into Pine Ridge to use telemedicine. 

Do you have ideas here? I've heard about some of them that maybe we can implement out there. What I really need is some junior co-PIs. I'd love academics who have done a lot of writing. We have about 15 papers that are going to be submitted and completed in about six months. I'm also writing the grant. I only have so much time. I'm 35% salary on grants right now. I'm looking for junior co-PIs that would be interested. Anyone who has gone through the training and you're looking for a job, we're looking for a program manager. 

Sorry to be bashful about it, but we put this out. You've put it on your Web site. But we're looking for a PhD, and MD/PhD or PharmD, because I can't go on as a PI for any more studies. What would be the rationale for anyone to participate? Well, if you analyze the data and you write the paper, you're first author. We can write you in as a junior co-PI to provide funding here. The questions that we ask in South Dakota we can ask in Wisconsin. And then there's the other. Here's the other commercial. Why would you want to come work with me? 

You don't have to live there. The Black Hills are very nice. It's a beautiful part of the country. It's the Badlands, pretty spectacular. I think I got these slides from Lisa. They decided to go up during the Sturgis rally. (laughter) They met a couple friends while they were up there. I'm just kidding, okay. All right. Here's the staff. 

I think we have about 13 or 14 people that we employ. This is Linda. She was just out here recently for training. There's a lot of collaborators. The initial collaboration started with the Department of Human Oncology. Now we're really collaborating with the School of Public Health, CDH and I'm really grateful for Sarah, Shannon, Lisa, Kathleen. I mean, all of you folks have just been really critical in getting a lot of this off the ground in areas that we lack the expertise. It's been very helpful to have friends at the NCI. You all know John Neiderhuber. He used to be the Cancer Center director here. 

He's now the director of the NCI. He's very much interested in what's going on out there. But we envision continuing with these same collaborators. Walking Forward. How did we come up with this logo? It actually came from one of our staff. We obviously couldn't go into the Reservation and tell them what the name of our grant was. Because, what does that mean? So, the idea was that we were going to walk forward. We were going to identify barriers. 

We were going to try to resolve a lot of these problems. We were going to offer solutions. And we were going to be there for a long time. This is Lakota for "walking forward in good health." This is a slide of the NCI. This is Norm, Frank... These are folks, these two came from Harvard. They were passionate and wanted to implement a disparity program. So, kudos to Norm and Frank, because they really got this program off the ground. And this is your own Paul, who's the chair of DHO. 

I just came from a meeting in LA a couple weeks ago. I really liked this quote. "It's really more about people than genetic and molecular footprints." Now, we're very much interested in all those genetic aspects, but you know, we're here, obviously, to help these people. So I call this the Walking Forward tree. This came from Bryce Canyon. Isn't that a wild picture? So, it wasn't one thing that we did that allowed this. Hopefully, we've shown some measures of success, but it's really been a multifactorial approach that's been required. We've been very innovative, and being thoughtful and listening to people in the community. 

It doesn't work if I'm the guy behind a computer writing all this stuff up. You need to have a community presence. That's what the CRRs have accomplished. All right, thank you very much. (applause)