Terrance Albrecht, M.D.
Director of the new Behavioral and Field Research Core
Barbara Ann Karmanos Cancer Institute; Detroit, Michigan
Professor in the Department of Family Medicine
Wayne State University School of Medicine
Dr. Baile: So why don't we get started. Good afternoon. My name is Walter Baile and I'm Director of the Program on Interpersonal Communication and Relationship Enhancement at M. D. Anderson and welcome today. I apologize for not being able to offer our usual lunch, but I see the clinics are busy so I'm hoping that particular restriction doesn't last too long, but so thanks particularly for coming today. And I have the great pleasure today to have a guest speaker for our ACE Lecture Series. Dr. Terry Albrecht who is down from the Karmanos Cancer Center in Detroit, Michigan, and Terry is a long-time acquaintance and friend from the Moffitt Cancer Center originally where we had met. I think I had been there a year and was probably leaving for M. D. Anderson at that time but she was entering and doing some very formative research there on communication skills. Currently, Terry is the Program Leader of Communication and Behavioral Oncology and Scientific Director of the Behavioral and Field Research Core at the Karmanos Cancer Center in Detroit, and also more recently Associate Cancer Center Director for Population Studies. So she's got a lot of administrative stuff on her plate too, I bet more recently.
She is also a tenured full professor in the Department of Family Medicine and Public Health Sciences at Wayne State University in Detroit. And Dr. Albrecht did her training at Michigan State where she got her PhD in Communication in 1978 and has held academic appointments at the University of Oklahoma, Washington, and South Florida where she began applying her communication research to key challenges in oncology communication such as accrual to clinical trials which she's going to talk about today. And she's going to present some information about her research, but also this unique model that she developed for capturing, coding, and analyzing in real time video of clinician, patient, and family interactions. And she's well-funded for her research by the NCI, NIH, and some private foundations and has over a 150 publications in this area. So it's a real treat to have her here today to talk to us about this important topic. Terry.
Dr. Albrecht: Good afternoon! And it's a real treat. I thank Dr. Baile very much for his generous hosting of a visit and the opportunity to come and see your incredible facilities. Coming from the heart of Detroit, this feels like literally a different planet and it's absolutely beautiful and I want to thank everyone here who's been so, you know, very generous with their time and interest in our work. So thank you, Walter.
Dr. Baile: I'm just going to pull this microphone just a little closer.
Dr. Albrecht: Is that better? Is that a little better? I also should just say, you know, for those of you who might be wondering because it always comes up. Yes, my mother did name me Terrance, alright. [Laughter] And it wasn't that my parents were expecting or wanting a male child. Actually, it's a very nice story which I won't go into, but I will tell you that I was named actually Terrance for another woman and it was a woman who supported my mother while she was growing up in the coalfields of Southern West Virginia, supported her to leave that environment and go and get her nursing degree at the University of Virginia at a time when that would have been difficult. So there she went met my father and, you know, the rest is history. So it's a great story. I should write about it some time I think, don't you?
I'm going to talk about clinical trial accrual and communication in clinical settings. And I'm, you know, very thankful that we've had the opportunity to do this work now at 2 NCI designated comprehensive centers. Our goal from the beginning, for the last 10 to 15 years that we've begun exploring this and exploring this whole process in real time, a front-row seat, looking at how doctors are talking to patients and their families about treatment options, has been to investigate how communication occurring between and among physicians, patients, and family companions influences how patients--whether or not patients make the decision to enter a trial. That's a very nice endpoint, alright, into studying communication. For the longest time since the early work was done on patient's individual difference characteristics, their age, how many children they had at home and so on. And, you know, it was those kinds of characteristics that were then correlated against, you know, various decisions that patients made for their treatment and somehow we missed that piece in the middle, the mediating process of communication.
What happens when the patient brings all of his or her history into that room? They bring their family or companions or significant others. What happens, what's the doctor bringing into that setting. What are the other providers who are present, and then what happens when they mix it up? What happens during that interaction, and in some way does that enhance or change or affect or somehow mediate statistically and in every other way the kind of decision that the patient makes about whether or not to enter trials. This work has been funded for some time and in fact, when I spoke at MD Anderson, I think it was 5 or 6 years ago, we were just beginning this R01, and now that we've finished, this is the paper that was published in JCO last summer. Along with that paper though, came an editorial in the journal about our work by Dr. Laura Siminoff who is just well regarded and very well known in the work of patient-provider communication. And in her editorial, she made three very interesting points. First of all saying that the work emphasized, you know, the primacy of the physician's role in this process.
We spent a lot of time enhancing patients' skills and in giving patients tools for making decisions and giving them various decision trees and helping them figure out what questions to ask, et cetera, et cetera. But, you know, one of the things that we need to be looking at more and that's the kind of work that Dr. Baile I think has dedicated so much of his career and many of you here is in terms of upgrading the skills of the physicians during this process and recognizing that this is a task like every other and how is it that we can really look at how these interactions are occurring. Their dynamics in real time and, to know, perhaps, you know, explore some of the myths that surround what is going on in the room.
What Laura also said in her editorial was that medical schools and residency programs must be investing more and more in this training and ended with I think a very important statement which was, "It's critical that physicians be trained to communicate effectively and efficiently with patients and their families by mastering the skills of relational communication." What your program here is all about. Pinpointing the content and information needs of patients for decision making should add efficiency and effectiveness to this process. The background of the problem of this process of explaining the option of a clinical trial to a patient and presenting that to the patient and their family and companions if present, stems from the idea that it is clinical trials which are going to find the cause and cure for cancer. Alright, if, you know, we're not making the progress that we need to be making in a time in a way. Yes we have lots of breakthroughs and we have lots of exciting headlines but, you know, let's forget it. Unfortunately, our units, the halls of our cancer centers are filled. And, you know, the numbers that abound out there are something of a mythology themselves.
Only 2 to 20 --it is stated that only 2 to 20 percent of all cancer patients are enrolled in clinical trials. Now, what that's not telling you is the fact that no one really knows the denominator of that. We don't know it at our cancer center. We didn't know it at Moffitt. Other cancer centers where I've discussed this say they don't know it. Maybe you know it here, but, you know, one of the things that this isn't telling us is at any given point in time, what percentage of our patients are clinically eligible for an available trial, alright. We don't have enough investigator initiated clinical trials and surgical trials in this country right now for cancer. We have an overly stringent eligibility criterion for many of the trials that we do have.
I work in the heart of Detroit and many of our patients are so sick with co morbid conditions that they are not eligible for the trials that are there. So we have the wrong trials there, alright. I mean that's, you know, that's an issue. And you know, as many of you know and it has just recently come out again in the literature, we have all kinds of complex social and institutional barriers that are delaying the implementation and the launching of new clinical trials.
And with the time lag that that takes, it's--you know we have many patients who frankly and at least in our setting are dying before they are actually at a point where they could have gone onto a study that might have been available for them if it had been in a timely way. Our special populations are underrepresented in most national trials. And so the question is why isn't every single patient that walks through the doors of a comprehensive cancer center, one that's NCI-designated as well as all others, I'm often reminded, why is it that they're not all on a clinical trial? We have this in kids cancer, in pediatric cancer, most of them are. But with adult cancer you know things are different and they're different and there are disparities in the way that they're different until we've got to look at this actual process of communication to better understand it.
We know through the literature, they're all kinds of reasons why patients accrue and don't accrue to clinical trials and I won't belabor the point because many of you, I'm sure, have seen these lists ad nauseam. But trust in the physician is really key here, alright, and altruism, alright? It will help somebody else. And then there's a whole list here of reasons why patients don't enroll. And you know what? You know you look at the, what--what's under girding all of this, there is sort of a latent variable that's operating underneath all of this and it is communication. It is the process of interaction.
So you know how is it that we, you know, are addressing these issues through that critical dialogue that very important interaction between the patient and the family and the oncologist about the trials and options. And how are we--how are we supporting that particular strategic communication process in the way that it needs to be. Now communication is a process, alright? And it has lots of functions, but it always occurs in a context. I come as I said from the context of urban Detroit. We're drilling down to the level of the clinical encounter, maybe I need to go over here. Well, [laughter] alright there, okay, the level of the clinical encounter here, but coming from a community that has been hard hit, alright.
We've--as I've said to Walter and others, we're living your nightmare, alright? Urban Detroit, you know we have--we have an underserved community and we at Karmanos are the safety net for our poor population in Southeast Michigan. Nearly 82 percent of our--of Detroit residents self identify as African-American. And we have the largest Arab-American population. One of the largest outside the Middle East, and frankly I believe, it's the largest in the United States. So we have cultural diversity. We have a growing Hispanic community of seasonal workers who come to Detroit in the summer and now are unable to get back south so they are--they're staying and, you know, just within the city. This number should change but that, you know, it's a--it's a conservative number that roughly a quarter of our population is living below the poverty line. That's very fluid. That poverty line shifts and lots of people are living very close to it and deep into it at regular intervals.
GM just announced 21,000 jobs that they're losing again early this week and we're seeing those numbers really change. Now, in terms of sociodemographics, we're living with an illiteracy rate in our--in the population of our city, of 47 percent. Forty-seven percent of our adults in the City of Detroit cannot read and write for daily activities. Our high school graduation rate is a very politically charged number but it hovers around 25 percent. Children born to single mothers roughly 3 out of 4 and our unemployment rate as of January of this year is 22 percent. We regularly, I think tie with you for having the highest obesity rates in the country. Not a contest that anybody wants to win but those are statistics, nonetheless. And we have one of the highest murder rates in the U.S.
We have a very contentious healthcare system that has fewer and fewer dollars. And as I said, we are the safety net in the city for our poor population. We have a cancer center, an institution that is very shortchanged in terms of resources. Space and personnel and time, we are, you know, at every level, we are--we have those kinds of challenges and it's with that kind of set of, you know, those realities really that we have a clinical interaction that occurs. And it's our physicians coming from that world into that encounter and it's our patients. So we, like you, want to be very patient-centered and the--I applaud the NCI for the great investment that they have made in the work by Ron Epstein and Rick Street on patient-centered communication and the functions of patient-centered communication in cancer care. They spent, you know, a great deal of time and effort and financial resources to pull this together and have this as a, you know, a classic set of guidelines.
The 6 core functions are fostering healing relationships, exchanging information, responding to emotions, managing uncertainty, making decisions, and enabling patient self management. And when we look at those in the context where we are, we have to take those then and, you know, and adapt them for the constraints and the settings where we are. We think, alright, as we look at this and being trained in communication. When I think of something as and you know the assumption that we will be patient-centered, alright, then says that in terms of our communication, we really will adhere to the adage going back to Aristotle. You know he's an old, you know, scholar of rhetorical studies. You know that it's what you say and it's how you say it, alright. Communication occurs on two levels. It's content message. It's what's said about that clinical trial. Do you go over all of the issues, the voluntariness of it, and the side effects that one may incur? Do you go through each of these particular items and we have a checklist.
And then it's how it's said and that's a little trickier but it's why we spend a lot of time on video capture. Because we're looking, you know, and trying, just beginning to, you know, to graze the richness of all of that nonverbal communication that's occurring. Its how interactants, alright, whomever they are say to one another, "This is how I see you seeing me. This is how I see us relating to one another". And that can either be for better or for worse, alright? And so all of these things tied together are what cultivates the kind of meaning that all those parties, you know, take away from them--take away with them from that encounter. We say, and I'm going to give you one more term here that kind of gives our perspective leading into the work that we've done is that if we're talking about communication occurring, the content and the relational level then we're saying that for that interaction to really work, alright, and to be patient centered, by the way, it's got to be, you know, this concept of convergence happening.
That's what we see as the sort of the mediator occurring, if communication is going to be effective. This goes back to some old teachers of mine. Those of you who know the work of Everett Rogers, he was a teacher of mine way back in Rogers and Kincaid in '71, you know, had, you know, kind of pulled this together in a nice way. So this stuff is pretty classic. But it's saying, you know, as we've adapted it the extent to which interactants, physicians, patients and family companions create mutual understanding and shared perspectives, alright, around diagnosis and treatment through these verbal and nonverbal messages that have content value and have a relational value associated with them. It's the extent to which, you know, we converge around meaning and understand that which we have converged around. It's not going to be 100 percent. It's going to be rather fluid as you can see here, alright. But as you think of everyone who's--who's connected here, we're going to see the set of shared accuracy and agreement only a little bit of a convergence here among these--in this diagram.
It doesn't have to be all over the place because that never happens. That's an ideal. But it's enough so that we can make a decision, so that we can feel that we've had some compassionate care so that we can see the expression and the receipt of empathy just enough so that these things do happen and people have then the ability to take the next step after the encounter. Our resources, as Walter was saying to you, are based on how we've captured these encounters which for a long time were kind of guessed about.
You know we would ask people before they went in the room what did they, you know, what do they think was going to happen and then afterwards I ask them what did you think did happen and you know, patients and providers were notoriously different in what they thought happened in although they were all parties to the same interaction. What we have is nonreactive video recording equipment which we've customized and we have a coding, editing and coding software and hardware, you know, to be able to process all of this. And we now have a video library that is--that covers not only the clinical trial and interactions that I've mentioned. But we've also done work with video recording parent-child interactions during invasive treatment, treatments for pediatric cancer and also looked at this in an underserved primary care setting.
And in all of those areas, we've been able to ask the kinds of research questions and come up with the kinds of important issues resulting from that which is to say that when you think about when people come into the encounter, they bring with them so much. So they bring with them their initial expectations. They bring with them the pathway that led them to that. In this case, this couple, you know, the son and the fraternity, you know, the father has a cancer diagnosis in a small community in a small community clinic. His son, alright, was in a fraternity with the son of the chief of surgery at the Cancer Center. They got together. His pathway coming into this into the clinic then was greased, alright. I mean it was set and when by the time they come, they've had concierge service to get them to that point and it's not good news, alright. It's bad news for him. However, alright, he has a connection with this physician. This physician has been handpicked for him. The needed physician happens to be from South America from a beautiful city that this couple has traveled to and so they talk about that versus this case, where this is a young woman from the City of Detroit who had a surgery for breast, a breast tumor and they didn't get all of the tumor. It took her three months to get, find her way to Karmanos, to us.
She is sitting here with a fellow who's actually a fine physician but she doesn't understand why he's a fellow and why she's not seeing the real doctor. She then is told that she had, probably has more cancer and it has probably spread to her lymph nodes. She is not real sure what that means but she has a dictionary with her and she is looking that up. And at one point, she bows her head and prays in tongues. In this case, so her pathway was very different, okay. In this case, we have--and I'm going to talk a little bit about this fellow later. But this is a fellow who is being invited to join a clinical trial and I will come back to him. But again, we have different pathways.
We have different participant configurations. She is alone. To a significant degree, our African-American patients come alone to their visits. Eighty-two percent of our white patients have somebody with them. Our patients, whether they're alone or with someone, ask the same number of questions. However, when there is somebody in the room with them, a companion or a family member, that person asks at least as many if not more than the patient. So automatically, half as much information occurs with that patient who's alone, who's probably a low-income minority patient as what happened with the patient who is there with a family member. And that's, you know, regardless of race and ethnicity, the--we have--But and in this configuration, however, it's important to recognize that this patient is not alone. As many of our community collaborators working with us on our research have said, "She is not alone, she is with her God." And it's important for the physician to be skilled enough to understand how to acknowledge that and how to recognize that and how to deal with that directly. And in this case, this fellow was alone or so you think, you know, without giving it away and I'll explain that in a minute.
You know, accuracy and agreement, information seeking, all of these come in here and there's, there's information that's transacted here. And when they leave, our work is only as good as what we can demonstrate. You know frankly, you know, in no short order, the kinds of outcomes that we can see, if we can see it and measure those behaviors that we see going on in that encounter, to what extent do we see any kind of affect of that later. This is not just an exploration of the dialogue and the transaction as it occurs. It always occurs for some sort of outcome. And the proximal and distal kinds of outcomes that our communication research has got to demonstrate is how it relates to things like treatment decision-making. Do patients go on clinical trials more when they have skilled physicians talking to them about that? Do we see them if they are not, you know, no matter what they decide to do? Is it informed consent and informed refusal? It's as painful for me to see a patient say no to a trial when I know they're sitting there with the physician who's not answered their questions which could be readily addressed.
Alright, that's not informed refusal. And we're not about trying to push patients on the clinical trials. I'm very adamant about that from an ethical standpoint. What I am adamant about is the idea of informed consent and informed refusal. And what we're learning is that a lot of the patients who say no say no because they don't have the information to say yes, and treatment adherence and compliance. You know, we have a patient who agrees to go on a clinical trial but now they've got to have the ability and the support and the information to be able to get to their appointments, have their transportation.
You know, they've got to be able, if it's--many of our phase 2 studies now are oral chemotherapy and they've got to figure out how to read those labels at home, alright. And you know the whole adjustment factor to this is certainly within the province of the work we do as social and behavioral scientists. So, this just gives you a little bit of an idea of what our setup looks like. These are our research assistants. This right here is one of our cameras. That ugly thing there that gets wheeled, the uglier the better, alright, gets wheeled in and we have 40 outpatient exam rooms in our clinic area. Each of those rooms is wired for our technology. The camera is within the cylinder. You can't really see it but we make it very clear to the patients. Everybody of course consents to this. If anyone-patient, family member, physician, staff person, anybody says no, they don't want to do it, we don't collect the data. But to the extent that everybody consents, then we wheel it in and explain to them this whole contraption. And you know what? People forget about it and we've done the studies to demonstrate that so the obtrusiveness really is not a problem and the reactance is not a problem scientifically. And often we have a couple of these units in the same room.
And then, in another domain, a remote area that is actually on a different floor, we have our research assistants who are sitting in front of the screen where they're actually seeing this and they can get separate shots of the physician and the family member and the patient. What she's doing here is on a touch panel screen. She's remotely able to control the cameras. They will pan and tilt up and down, and they can zoom in and zoom out. And these people move around in these visits, right. So, and we have a lot of what we call front stage and back stage behavior. Now, it's interesting to see how people use that time before the physician comes in the room, that anticipatory uncertainty. What do they say? What are they thinking about? Are they using it as a time to, you know, to think about problem solving, to think about supporting one another? One patient--patient's wife was reading him scripture and then--or do they use it to fight? Are they using it to fight?
Alright and you see, we see it all. Again, it sets the tone for what happens when the physician comes in, alright, and has to, you know:, address all of the issues that he or she has to address. And then these are recorded and then they turn--it turns to a CD or DVD rather that we then use back in our lab for coding and analysis. I will just--I'm not going to cover this, but just to show you that we've done a lot of work on why--first and foremost, why go to the added expense and difficulty of creating such an elaborate video recording system. And we feel very strongly about it from a validity standpoint in terms of the work that we're doing. It's certainly a place for audio tape data but we--for a lot of the work that we're looking at, we really do believe you need the nonverbal, behavior nonverbal communication is what it is called scientifically and that needs to be captured because otherwise, we're losing too much. And when we tested that, we found that coders gave different judgments based on whether they got audio data only to react to encode or if they had audio and video data together.
We also published on the lack of reactants and obtrusiveness of the methodology. The data collection for the study that I'm talking about was sort of three-fold in terms of the process. Based on characteristics we obtained on the patient and the family member, these were self reports of various sociodemographics that we obtained from them prior to their visit with the physician, then we had real time video recording of the clinical encounter and then roughly a week to two weeks later, some time after the patient had at least made some sort of decision or intended at least to make a decision and sort of knew what that was, we contacted the patient and had a short over-the-phone interview with them. So we were able to see. This was our set up at Moffitt and in this case, you see that the camera looks a little different. It's sitting right on the desk where the patient and the family member are having discussion with the physician.
We--our observational coding was of 235 video recording interactions at two comprehensive centers, as I said and our coding system was something we developed, you know, we started doing this a number of years ago back when I was at Moffitt. So when I was at Moffitt, it was the Moffitt Accrual Assessment System and when I moved to Karmanos, it became the Karmanos Accrual Assessment System. Last month I had presented this work at Moffitt and happened to mention that and I got a real boo in the audience [laughter] for that whole thing. They, you know, they wanted to know I didn't, you know, somehow link the M and the K. But the thing about it is we're constantly, you know, sort of tweaking this and working with it and this is a system that's setup so that we can code physician-patient interaction and then we code also the physician-family companion interaction and look at it that way.
We'll be, you know, I think coding some of these data the rest of our lives but that's at least what we've had so far and what we've been publishing on. Because we see communication on a content relational level, that's how our coding system is designed. At the content level, this is a coding system about accrual to clinical trials. So what are the things that are in an informed consent that, you know, the patient is supposedly to be informed about and those are like I said, side effects, eligibility, voluntariness and now you can, you know, click it off. It's, you know, really very simple and what we're simply doing is checking off when the DVD is inserted into--in our lab at the coder station, they have double screens and so, they're seeing the interaction on one screen and our coding system comes up on the other screen and it's a point-and-click. Every time they see that, you know, particular message given, they can make a point on that or they can also mark right on the tape where that occurred so that we can do some interesting things with time lag and with, you know, whether or not topics are returned to and you know, how the course of the interaction seems to play out.
One of the things that we're trying to do is we're trying to look at if you almost think of it as a distribution, for those of you who --you know, the human genome project, if your buff's about that, you know and you really, you know, kind of like seeing some of those that net charting of--we're in the position to be able to look at behavior that's occurring simultaneously and sequentially. And one of the things I'm trying to do now is take a look at what is the relative distribution and timing of supportive messages throughout that--those discussions where the patients afterwards say, you know, that they had--they feel a lot of trust and empathic support and so on. I mean these are the kinds of things that you can look at because it then gives us the sense as to, you know, for how some of these interactions, you know, perhaps maybe, you know, shepherded a little bit better. When it comes to relational level analysis in our cause, we have a series of ratings that are--you know, these are summary kinds of ratings, hierarchal rapport, connectedness, mutual trust, responsiveness to questions, these are judgments that our coders make regarding the way they saw that encounter unfold.
We've, you know, we have very good reliability on this. It does take a lot of training but it's been really very helpful. The kinds of things that we're doing now is going back into this because we've got the ratings where we have the high and low ratings that were done by our coders. But then we also have the patient telling us, the patient perception of how much they trust the doctor right afterwards and how that played out. And so, what we're doing is we're going back with a series of different kinds of coders who are looking at this and who are saying, "Alright, as you start looking through this encounter that has been rated below trust, you know, then our coders are blind to it but we're asking them to tell us, you know, where instances of trust or lack of trust are occurring, what are the behavioral correlates of this that we might start to track, and is there any agreement on what some of those behavioral patterns might be.
That's, you know, that's another thing that we're looking at and we're also looking at this in terms of having this viewed by our community coders who are people who are more like our patient population then like us as academics in the lab and to see whether or not maybe there would be some dramatic differences and some dramatic explanations that might differ between those groups. Final sample, again, you know, we had a very interesting set of patterns for all of the video recording that we did, honing down to a clean interaction where there was a clear offer of a trial, really narrowed down our end dramatically and that's one of the real surprising factors about this, that we basically came up with 35 where there was a clear offer. We've had some medical students to do some of this coding too. First year, just completed their first year and a couple of times they say to us, "You know, I'm not sure what they were offering that patient. They said a lot of things but I couldn't keep track what they were saying, you know," and again, this is part of the difficulty of communication, is that we're not often as clear as we think we are, particularly when we're stressed and we've got, you know, an overloaded clinic and so on, and people don't always understand particularly when they're challenged at levels of literacy and emotion and distress and so on.
That really does narrow what people are able to think about and process. And so, it is, you know, it is a very difficult encounter that we need to understand better and we came up with 35 of them that we could study very carefully. That's telling us something about just how precious these opportunities are to offer clinical trials to patients. You know, generally now, you know, again I think in some highly resourced centers that may not be as much of a problem. It is for us and it is for many centers like us. Our physicians were--again, this gives you a sense of them, they were fairly experienced 15, they were all male and had--again, had been offering trials for some time. The results, okay, of those patients offered a trial, of those 35, 77 percent reported that they decided to enroll, right? Those--I mean that's much better than the 2 to 20 percent that you hear out there and I think that's why that's so misleading, alright.
When a clear offer is made, we're finding that, you know, the patient seemed to be going on this. Does this need to be replicated and tested again and again and again in different places? You bet it does. But what we're trying to open up and say is that we think when we're really in there to look at things, that it's not necessarily the case that the reason for low accrual rates in the United States, it's not necessarily because we've got recalcitrant patients that just don't want to have any part of research. But this doesn't seem to be--you know, it is for some but by and large, if a physician makes a recommendation of a trial to a patient, we did that study where we looked at what did the physician say, that they did indeed say, "I recommend the study and/or I recommend the study for you." You know, that did have an impact.
Now, that's controversial because there are some people who say that physicians are not in the business of recommending clinical trials to patients. For equipoise reasons, they need to be very neutral about that. But aside from it, we are finding in our work that when offered a clinical trial, most of the patients that we're seeing report deciding to enroll. But there's a lot of misperceptions around that. 39 percent of the patients who only discussed the trial, there was no offer, clear offer made told us later that they were offered one. So they thought that by discussing it, they were being offered a trial and some of those people even said they thought they were on the trial but they weren't sure. 14 percent of the patients who were clearly offered a trial, or unambiguously we can see that that offer was made, said they were not offered one, okay?
Patients who decided, based their decision to enroll for personal reasons, which you know, we've known for a long time and on the oncologist's relational communication behavior, trust, rapport, that sort of thing. Less so in terms of all of the content stuff, more on the relational level, and as well their confidence in the physician in his or her expertise and credentials which of course often happened because of what the physician is saying about the disease, right? So it's a very interesting kind of nuance there that takes place.
If you look at some of our correlations and this was a time--you know back at the time we were observing the interactions, so this is the interaction and then a week to 2 weeks later, what are they telling us? Well, we're finding that the relational side of the picture, those relational judgments that I was describing, do play out against you know the decision to accrue. It does play out in terms of how people feel about that decision that they made and how they think their family members support that and also the factors that they said were influencing the decision that they made. For instance, if there was a great deal of relational communication going on, they had a little less interest in worrying about whether or not the perceived costs of doing the trial where factored. That seems to fall out.
If the physician, you know, listened and was supportive, that played out in some interesting ways. The--that the side effects were or were not manageable and the opinion of the family member all played out in interesting ways against whether or not--against the kind of relational skill, I should say, a relational behavior that we observed to see in that clinical visit. Message content played out more in terms of factors influencing the decision and how they felt about the decision that they made which I thought was kind of interesting. And when you put it all together, alright, it is telling us that this is kind of an interesting web. If we think that communication is a complex difficult thing, we are right, alright. There is no one right way to do any of this. And it is something that, you know, that does have a lot of complexities related to it.
But there--you know the number of these skills I think can be taught and they are--what our data have provided us are alternative ways in which physicians can be shown ways to do things like for example explain the idea of randomization. We see some really great explanations and some that really aren't all that great, alright. And we can see what happens when some are used versus others. And so from an evidence-based practice standpoint and from training from the perspective of the research that we've found, we think that this may have some value.
The other thing that I will say is that we've found for example that explaining side effects. To tell a patient they're going to lose their hair, alright, it creates as you know--sometimes when you tell the patient that they've got metastasis to the brain, they don't do anything and then you'll say, well, you are going to lose your hair as part of the treatment and that's when the floodgates open. Alright, there's something about hair loss that has some very dramatic effects where it's almost, you know, the tipping point. What you then tell the patient about the hair loss has some interesting consequences. It's one thing to just leave it at that. It's another thing to say, oh, and we'll just make bets about what color and texture it is that's going to grow back. The only one laughing at that is maybe the person who's said it, but that goes over like a lead balloon, but we hear that said.
We also hear the reassurance of, well, it will grow back. Alright, and it will grow back and you'll--and it will seem--as you're healing and as you're getting well, reassurance is fine. And then there is in social support lingo, there's the whole area of tangible support. What is it you're going to do for me as a result of that side effect and to say things like well: you know we have Toppers at Moffitt. We had a place called Toppers and it was this beauty salon downstairs and you could make an appointment, you could get a wig. We'll give you a prescription for a wig and they're really nice folks down there and they'll type your hair for you and they'll order it and you'll have it when you need it, you know, and we'll just take care of that.
What you would see in terms of the general relaxing posture of the patient at hearing that was very different from the situation where you're going to lose you're hair and maybe would say, "Well, we'll write you a script for a wig, alright." It was very different kinds of things there, but we were learning that directly and it's some things that our fellows have been--it's been helpful for our--when I've talked about this to our fellows because they're saying, "Oh, you mean if I tell you what I can do for you." It's not--and we found literally it's not the number of side effects that are mentioned that makes a difference. It's really not an issue. But it's what are you going to do for me doc when I have these side effects and, you know, and by telling me what you're going to do for me. What's really nice about that is you're telling me how much you care for me, alright, and how much you're there and you're--you know, it's going to be patient centered and so on. So, you know the strategies abound in these data and it's one of the reasons why I think I'll be working with them, you know, for a long time. The one thing I wanted to say is, remember this fellow, alright, this patient, he's here and he's come back for a checkup. He's just been through treatment for throat cancer and he is being offered a pill. It's a study, a phase 2 study where he takes a pill and it will prevent--they're hoping that it will prevent recurrence within a year. So if he takes this pill periodically for a year and he's saying to the doctor, "Well, you know, I really don't know what to say," he's sort of a man of few words, but you know he says, "Look, I just got back to work. I've been really tired and I got to go to work." You know, and he's got to go to work. Now he's alone, okay, his wife is not there, she's at work. The physician gets up and leaves the room and when the physician leaves the room, he takes out his cell phone and calls his wife and doesn't say hello or any like that, he just says, "They want me to go on a study." Now the physician had told him previously that, "Look we have--you're not going to be tired, you'll be fine. We have 13 or 14 people already on the study and they're doing fine, they're doing fine, you'll be able to work." So he calls his wife and he says, "They want me to go on a study and they've got 30 or 40 people on it." So now that number has increased, alright, and there's silence on his end.
And you know, I mean in company here I should, you know, tell you what I imagine she might be saying but a week later, alright, he tells us no, he didn't go on the study. He didn't go on the study. Here, the physician has come back in, alright, and the--you know what, I'm sorry. I'm telling you I've got confused with my own data, oh dear. Sorry, right, can I just back up one moment, alright. Let me just finish out the story here. Okay, this is not him before, this patient--I have the other slide in the other presentation. I have them in those places. This fellow here is, he calls his wife as I said, physician comes back in the room, doesn't know that this discussion happened. The patient doesn't tell him he called his wife and the physician keeps saying, "Yeah, now I want you to go on the study now. Next time you come, I'm, you know, going to have the forms for you." A week later, the patient says no, he tells us he didn't go on the study. The reason he didn't go on the study was his wife didn't want him used as a guinea pig, alright. Now, the thing about this, he is alone, he does not accrue, alright, and why? Because the person who made the decision wasn't even in the room. Now, what does that tell us? If we were really patient centered as we ought to be at our cancer center, we would be saying who else is involved in this decision with you and, you know, could we call them now, would they like to call me, cell phones all have speakerphones now, we could bring that person, you know, virtually into the room one way or another and have that discussion. That would be patient centered, alright? We don't--we would--we didn't even think about that until we really saw these kinds of data.
In this case, this patient is also alone, same cancer, same trial being offered, alright. And in this case, he goes on the--he does go on the trial and he does so because of altruistic reasons. He says, "I've been blessed, I'll do whatever I can if this will help someone else," alright. And so it's a, you know, again these are very different kinds of patients with very different kinds of life situations and life motivations and, you know, issues at hand and, you know, to be patient centered, we've got to understand all of these. And I tell you, without some of this work, I'm not so sure that we would, you know, we would really be in a position to be able to do this level of analysis.
I know I'm just about out of time--out of time, so that this is the patient that has the uninformed refusal. The decision maker was not involved in the discussion. Bottom line findings from this, relational communication positively impacts patients' actual decisions to accrue and it impacts how they feel about their decision. Information about the protocol affects how patients feel about the decision they've made and their reasons for it. And what we want to do now in our new R21 is to back up from this encounter, backup through the process upstream and take a look at what's happening in the multidisciplinary, you know, tumor board meetings and use some of our technology to help, you know, to fund the kinds of clinical trials nurses who need to be in the meeting working with the physicians in the clinic and then supporting our physicians as they move into that visit. Because in some ways, you know, the physician really needs to focus on some of the relational and the diagnostic issues and do that.
And then there's lots of logistics and details about the trial that the clinical trial nurse could then ease in and take over and offer. And it might actually help the physician a little bit better. You may already have a system like this similarly in place. But for us what we're finding is that in those cases where the clinical trials nurse comes after this encounter but just comes in to talk about the study. They're too disconnected from the process and from the relationships and from the experience of the patient at that point. And they're too disconnected from the doctor and they're too disconnected in terms of discussion at the MTD tumor board.
So, you know, what we're trying to do is create convergence across the system so that things are organized a bit better and we have then less error. My collaborators are the ones who make all of these happen and many of them you will--some of you who's work you may be familiar with, and I thank you.
[ Applause ]
Dr. Baile: So thank you very much for that really, really interesting presentation and your research is really cutting edge and I wonder if there are some questions from the audience? Yeah.
[ Inaudible Question ]
Dr. Albrecht: That's a great question. I've been asked by our media people to restate your question and I'll just give an abbreviated restatement, but it's a question of time. Does it take longer to accrue a patient to a trial particularly when we're paying attention to all of these communication issues that we're talking about? So to successfully enroll a patient on a study, is that going to take longer clinic time for the physicians? And that's one of our main concerns. Actually, when we did the original pilot work on this, we found that it didn't. It was a matter--the question really and this is was back at Moffitt. When we timed those, what we were looking at was on the issue of how that time was spent in the visit with the physician, okay. And when we moved then to Karmanos there was a little bit--we were seeing more of a difference that the, you know, the clinical trial accrual discussions did seem to be taking longer for the ones who accrued. But, one of the things about that that we were observing was that there seems to be a fair amount of time that was devoted to a physician saying, "No, I can't answer that question about insurance. No, I can't answer that question about transportation. No I can't--" You know, and they're literally throwing their hands up and saying, "Yeah, going through--patients really pressuring with questions about how are they going to live out the experience of this trial? And the physician is saying, "You know, I don't know, this is what the trial is though and this is what it means for you medically." And that's what's taking up time. So, that's why we're really thrilled that we're going to be able to do this R21 because we're saying, "Alright look, you know, if you have somebody in the room who relationally is part of the team in the patient's eyes and who is sort of, you know, designated and has the imprimatur of, you know, given from the physician. Alright, that's the person who can then say, "We'll go over that and I'll work that out with you." You know those are some, yes, you know, we know about that and that's what the clinical trials nurse is doing. In fact, I have clinical trials nurses who are coding our tapes right now and they're actually marking the amount of time that could be off loaded to them afterwards if they were there. And they're also seeing places where if they were in the room, some of the information that the physician is giving is actually not consonant with what's actually, you know, detailed about the trial. [Background music] So, it's kind of a convoluted question but I think being able to be in there and to see this helps us say, you know, maybe we can, you know provide a little bit more structure to what needs to be accomplished there, for these things to be a little more streamlined. Yeah?
[ Inaudible Remark ]
Dr. Albrecht: Thank you.
Question: I was imagining that to be taped here and kind of give this talk that you have this on some kind of agreement
Dr. Albrecht: Yes.
Question: that Walter and I*CARE here kind of gave you and I haven't seen it, so I don't know what it looks like. But I'm imagining there's a paragraph or two that makes perfect sense to you that's no problem.
Dr. Albrecht: Yeah.
Question: But have you ever given a talk where you actually have like 6 or 7 pages that are complex, things about the materials and you probably begin to feel, wow, you know this is way too much for me or I need a legal representation just to know what I'm even signing [inaudible].
Dr. Albrecht: That's right.
Question: And so your level of trust, I guarantee you, the author gave you 7 pages to look at--your level of trust in coming here and giving this talk would be diminished.
Dr. Albrecht: No way.
[ Inaudible Remark ]
Dr. Albrecht: Right. We're just giving more honoraria here.
[ Laughter ]
Question: It's all perfectly okay to turn [inaudible]. It affects you as much as it affects us. Seven pages would be a deal breaker for you as far as trust.
Dr. Albrecht: And you're giving that to me under circumstances where my life is at stake, okay? Talk about emotion charged, you're asking me to sign this?
Question: So I've decided I wonder about that part and I [inaudible].
Dr. Albrecht: So that's why the relational side--I'm sorry to interrupt you, but that's why the relational side I think is a no-brainer. You know, my physician cares about me, you know, why is--you know. And you know to be perfectly honest, when we talk about informed consent and informed refusal, you know, legally and ethically we're going to be talking about this forever. This is not going to settle the issue. But to have the right people to step in at the right time, when a patient's head is in the place where they can at least hear some of these and hear it in different ways.
If I've got, you know, if I'm a low literacy patient and you start talking to me about Taxol and infusion and this arm and that arm of a study, alright, you've got to change your rhetoric, okay, and you're not going to. And I'm not so sure that you necessarily need to. But the physician who then is able to step into a patient's metaphor for example and is able to--you know, we have one physician who uses--I don't know if you all still have paper on your exam tables and so on, he writes on that, you know, he does all of this and brings people in close and then, you know, rips it off and hands it to him and like, you know, they take it home. I mean these are just little gimmicky things, right? But what it's doing though is it the--you know, the touches that signal patient centeredness are real behaviors and the real behavior of how I'm going to explain your side effects to you and here's what we're going to do for you and here's what I want you to think about, alright, and you know--and you know, I know this is hard, okay.
I love Walter's statement that you don't have to fill every silent [laughter] space there. You need to give people a chance to digest what they're hearing. You know, all of those things and with--you know, because a lot of the nuts and bolts can be picked up by a skilled trained clinical trials nurse. Patients want to hear about a clinical trial from their physician. And unfortunately the ones that don't go on are the ones who are told by the physician who is almost leaving the room and saying, "And, oh by the way, we've got a clinical trial and, you know, Ms. so and so is going to explain that to you afterwards." What kind of intro was that? Yeah?
[ Inaudible Question ]
Dr. Albrecht: You know, we don't really have--that's not some work that I directly do, some of our patients and patient health educators and so on may be using some of that. I know about some of those decision aides and certainly the one that we're doing right now in the study was Fox Chase [phonetic], is a modified version of that. It's all digital and it's all on screen and, you know, they're actors that are on there and, you know, they're telling, prepping the patient to think about the kinds of things, benefits and barriers that they might encounter in going on a clinical trial. And so prepping them in terms of some things they might ask their doctors and so on. But in terms of the decision aide afterwards, well, should I do this, what's the consequence if I do that and, you know, those sorts of things.
I know they've had some success with that at UC San Francisco, but we don't really--you know, we haven't used those systematically and mostly because the bias of many of us on a research team has been--it's easier to change 50 doctors than it is to change--it's easier to change one doctor than it is to change 500 of his or her patients. I don't know if that's true or not but, you know, that's what has been the feeling of many of our people.
Dr. Baile: You know, just a last comment. It's very interesting because I think most of us who went to medical school or nursing school or other places, how many of you had a course in how to educate a patient. I mean, you know, how you explain your half, okay, two people. [Laughter] Great. Good. But most of us who explain these kinds of things to patients don't have a background in one of the best aides to use on how you make diagrams, things of that sort. So, maybe that's another clinical trial. But thank you so much Dr. Albrecht.
Can you please fill out your evaluations? You know that that would help us enormously. Just take a second.
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