 Anyway, last on our topic today, Lynn Janssen is the inaugural holder of the Madeleine Brill-Nelson Chair in Ethics Education in the Center for Ethics in Health Care at the Oregon Health Sciences University. She worked as a registered nurse before earning a doctorate in political science at Columbia University and completing the ethics fellowship at the McLean Center. She's editor of Death in the Clinic and is associate editor of the journal Theoretical Medicine and Bioethics. She has published widely on medical and research ethics. Please help me welcome Lynn Janssen. Well, thank you. Thank you, Mark, for inviting me. I've always loved coming to see everyone again each year. This is the disclosure form. I have no financial relationships to disclose. And I just want to start out by saying that in past talks that I've given here, basically the last three talks that I've given here at the Fellows Conference, I presented data to show that patient subjects in early phase cancer trials are unrulystically optimistic about their participation in these trials. They expect to benefit more than others who are in the same trials and they also expect to confront fewer risks than others who are enrolled in the same trials. In addition, these patient subjects often harbor the therapeutic misconception. That is, they confuse the context of research with the context of therapy. And the fact of the therapeutic misconception in this context really isn't new. We've known about this for the past 25 years. But what is new is the fact that my study team and I have found that unrulystically optimistic patient subjects tend to have a greater degree of the therapeutic misconception than those patient subjects who are not unrulystically optimistic. So unrulystic optimism in this context seems to be quite significant and it also seems to bear directly on the quality of informed consent to participate in research, especially early phase cancer trials. And it's natural, I think, to wonder what actually accounts for unrulystic optimism in the first place, what motivates it. Now some people have suggested that the patient subjects in these trials are just expressing hope. Their prospects are grim and their unrulystic optimism is a product of their hopefulness in the context of these grim prospects. This suggestion is understandable but I don't think it's correct. It's really far too simple and it doesn't really take into account all of the research that's been done by social psychologists in the realm of unrulystic optimism over the past several decades in other contexts. This hopefulness explanation, as we might call it, also might lead us down some very unfortunate paths. For if unrulystic optimism is generated by hopefulness, then efforts to improve informed consent may come at the cost of taking hope away from these patients. So today in this talk I want to outline a different explanation for unrulystic optimism among cancer patients in early phase oncology trials. And I'm going to call it the mindset hypothesis. This hypothesis is rooted in the dual process model of decision making that has been studied extensively in recent years in social psychology. I'll then very briefly discuss some empirical findings that support the mindset hypothesis as it relates to unrulystic optimism in early phase cancer trials. And finally I will again briefly explain how mindset hypothesis can inform promising interventions to improve informed consent. But first I need to explain what I mean by the term mindsets because I'm using this term in a very highly specific way. And my discussion of the term draws extensively on the work of Peter Goldwitzer, who's a psychologist at NYU. In his research, Goldwitzer sought to understand how people pursue goals and plans effectively. He observed that successful planning involves different action phases and these action phases can be explained like this. First choice must be made between potential goals. Then decisions must be made about how to implement the goals. Actions must be taken to realize a chosen goal. And finally, an assessment must be made about what has actually been achieved. Now naturally, each action phase presents its own challenges and Goldwitzer proposed that different cognitive orientations or mindsets are activated to address these different challenges. Of greatest importance are the different cognitive orientations involved in the selection of a potential goal and those involved in the implementation of the goal. So the former he referred to as the deliberative mindset and the latter he referred to as the implementation mindset. Now one of the striking features of Goldwitzer's research is that he discovered that these two mindsets, the deliberative and the implementation mindset, actually affect how people process information. As he put it, people who ponder a goal decision develop a deliberative mindset that allows them to accurately assess whether a desired outcome can be controlled by their actions or not. Whereas people who are in the pursuit of a chosen goal, that is in an implementation mindset, actually develop a mindset that fosters illusory optimism with respect to controlling this outcome. So in other words, when people are asked to consider the likelihood of success at a future goal, so for example, writing a great American novel, they'll tend to actually make more accurate predictions if they're in a deliberative mindset. However, once they've committed to the goal and are in an implementation mindset, that is once they're actually in the process of writing that great American novel, then they're going to tend to overstate their ability to succeed at it. So you see the implementation mindset fosters illusory perceptions of control and interestingly, illusory perceptions of control have been shown to be strongly related to unrealistic assessments of expected benefits and potential costs of planned directed action. And this is really the power of mindset theory and what's really important about it. Mindset theory reveals in an interesting way how risk benefit expectation and risk perception can be mediated by one's cognitive orientation. Now, I just want to mention one further point. Research has shown that those in an implementation mindset exhibit a bias toward information that's relevant to goal pursuit and against information that calls into question or doubt its desirability or feasibility. This closed-minded focus, which is associated with the implementation mindset, contrasts pretty vividly with the deliberative mindset where people exhibit an open-minded, relatively even-handed and accurate appraisal of evidence presented to them. So the upshot is that once people are in an implementation mindset, they're both more likely to have unrealistically rosy views about the goals that they've adopted and they're less likely to reconsider their commitment to these goals in light of new information that may call them into question. Okay, so now that I've set out what mindsets are, I want to now turn to the mindset hypothesis. And the mindset hypothesis is simply that unrealistic optimism that is exhibited by patient subjects in early phase cancer trials is the product of an implementation mindset. I first proposed this hypothesis in a paper that I published in the Hastings Center a year or so ago. But it's just a hypothesis and I wondered what type of evidence might there be to support it. Well, the first thing to say is that it's extremely plausible to think that patient subjects that we've been studying, and that's over 240 over the two studies that we've conducted thus far, these patients who were enrolled in early phase cancer trials, it's plausible to think that they are in an implementation mindset when we are actually questioning them, because after all, they've already agreed to participate in the trial and they've chosen research as their primary plan of action. They're now just executing that plan. Also, I knew from earlier work that I and my study team had done that patients participating in early phase trials have high and indeed unrealistically high perceptions of control with respect to their prospects of benefiting from participating in these trials. And this too is consistent with the mindset hypothesis as I just explained the implementation mindset gives rise to illusory perceptions of control. But what further evidence might bolster the mindset hypothesis? Well, one thing that I was interested in exploring was the expectations of patient subjects who had declined enrollment in these trials. Whatever we might say about them, they're not in an implementation mindset, at least not with respect to trial participation. So if the mindset hypothesis were correct, we should expect them to manifest little or no unrealistic optimism about trial participation. And in a preliminary study of declineers, this is exactly what we found. We found that declineers were not unrealistically optimistic about the risks and benefits associated with trial participation. Unlike trial participants, they didn't think that their chances of benefiting from trial participation were greater than other people who were asked to be in the same trial that they were asked to be in. Of course, ideally, one would like to actually interview patient subjects who have not made a decision one way or the other about trial participation and who are really in a true deliberative mindset about that option. But this objective, this ideal, actually may be more difficult to achieve than it seems. In fact, in my conversations with oncologists over the years, it's been reported to me that the majority of patient subjects who come to enroll in trials have actually already made the decision to enroll in the trial when they come to talk to the physicians. Their decision was made before, actually, the formal informed consent process took place. So people actually are consenting to participate in research when they're already in an implementation mindset, it seems. What we might call a deliberative consent to trial participation may not occur, or at least maybe it does not occur that often. But of course, we should care about deliberative consent if we're to care about consent with realistic expectations and accurate risk benefit assessments. And I think we should care about it not just at the beginning of the trial enrollment, but throughout the entire trial participation. So I don't have much time left, but I want to just move in gesture toward how we might improve informed consent in this context and perhaps even provoke a deliberative mindset on the part of research participants, given the plausibility of the mindset hypothesis. And the key idea here is that we want patient subjects to give not just informed consent, but informed deliberative consent. And we want them to consent when they're in a deliberative mindset and we want them to consent in deliberative mindset precisely because this is the cognitive orientation that enables people to accurately assess information that's being presented to them and accurately apply this information to themselves. So how might we do this? Well, goal with sir discovered that it's actually pretty easy to switch a person from an implementation to a deliberative mindset. Basically, all you have to do is present the person with a problem to think about. Then you ask that person to think about the pros and the cons related to that problem. And then you ask them to go back and consider the the project or the the goal that they're currently implementing. And in countless number of cases and experiments doing just this sort of thing. Goal with sir and others have found that people who have gone through that process actually tend to have more realistic assessments of the goal that they're actually pursuing. So our next project is to test such a deliberative intervention with patient subjects who we've been studying is such an intervention which I'm calling the deliberative mindset intervention were found to be successful. It would provide further support for the mindset hypothesis. But more importantly, it would show that we can improve risk benefit assessment among patient subjects in this context and perhaps beyond. And that we can do this not just at the beginning of enrollment but throughout the entire process of research participation whenever it's necessary to bring them back into a deliberative mindset. And you know this is important because other efforts to improve risk benefit assessment in clinical research have really failed to be successful or is as successful as we've hoped unrealistic optimism and therapeutic misconception are just notoriously hard to combat. So this would be an important step forward and notice our intervention need not take hope away from cancer patients. There is no reason why people who make deliberative judgments about their lives should be any less hopeful than the rest of us. So I will stop there and note my acknowledgement and thank you very much for letting me be last. Open for questions. I see Mark. Dr. Siegler, do you have a question? Okay. Okay. Let him come up here. He's talking after. Thanks so much for clarifying some work that we did in the early 90s on on the intrinsic hopefulness of patients who entered phase one research how different they were from other cancer patients who as you pointed out might have had an opportunity to to participate in phase one but elected not to. Now we were never able to study that other group the way you already have. Do you really think that you can switch the implementation mindset to the deliberative mindset in in this very unusual group of participants in phase one cancer research. I think the analogy are transplant living donor transplant donors who have made their decision long before they've spoken to doctors. Can you really affect a change in that process whatever that process is that would change the phase one cancer patient or the living donor? Yeah, that's really an excellent question. Thank you, Mark. So I have two responses to that. First we've done a little pilot experiment using this deliberative mindset intervention on patients who were enrolled in phase three cancer trials. That was a convenient sample and we did find a dampening of the of unrealistic optimism after the patients received the deliberative intervention. Moreover, we found a dampening of a therapeutic misconception as well because these two things tend to be related. We want to see if it's possible to do that in an early phase cancer trial. But my other my other response to your point is it's a good point because there are some research to suggest that when people become very entrenched in a plan of action that when when a person tries to move them into a deliberative mindset, they become more entrenched. So they just dig their feet in even harder. But we don't know how this would work in this context. So it's war. I think it's really worth exploring, especially since the intervention itself isn't complicated and it doesn't really take that much time. So it would enable researchers to to sort of engage in this corrective measure throughout the process when new information came available without overburdening the patient subject with another yet another instrument. But that's an excellent question. Thank you very much. I wonder if one potential way we could help people avoid the sort of pitfalls of the implementation mindset is to make some of the alternatives to the really aggressive treatments less frightening. And it seems to me that one reason why people develop that sort of over optimistic mindset is that the alternatives are so scary and are often presented in a way that offers so little opportunity for hope that that it really reinforces the cognitive biases that you're they are talking about. Yes, I just I have to probably just I think that's a good point. And I don't really know what else to say to that. I think it's a good point. It's well taken. Hi Bob Chung from here in Chicago. I maybe I haven't understood you correctly because the terminology is a little bit new to me, but I would assume that a participant research potential research participant considering whether to enter a study or not would be deliberating about that decision and would at that moment be in a deliberative mindset. And isn't your proposed intervention kind of like having a deliberation about whether or not to be in the study? And and I wonder if the the the well so that's my question. So right so yes that's my claim that I believe that what happens is that when people come to the the informed consent process they have actually made up their mind so they're in an implementation mindset. And so one would hope that at some point some deliberation went on, but the the context in which that deliberation went on, the information that the person was given about participating in research, all the stuff is unknown. And so so while yes a deliberation may have gone on it may not have been the kind of deliberation that we want patient subjects to go through when they're actually consenting to participate in trial, which is a deliberation about the study in front of them. So so so we don't we don't know the quality of deliberation that goes on prior to coming into the office. And so again this is something that I think is worth studying and investigating. Oh I see so your hypothesis is that they've come to this discussion already with their mind made up. That's my that's correct, that's correct. And and that's been my experience too because I can tell you that we have it's not only that the declineers had less unrealistic optimism, right? They didn't think that they're going to benefit. They made the decision not to participate in the trial, but we had a hard time finding declineers. In the reason we had a hard time finding declineers according to the many oncologists with whom I spoke is that nobody declines when they go through the informed consent process very few people actually decline. So the 15 people whom we interviewed were true declineers I guess. But but all the other people had already made up their minds when they would go into the discussion. But just because they decline doesn't mean you can jump to the conclusion that they came to the discussion with their mind made up already. No, no, no, no, no. I'm saying that the I'm saying that the people who are who are agreeing to participate seem to have that's my hypothesis have already made up their mind. They're in an implementation mindset. It sounds like there needs to be further discussion between the two of you. But thank you so much for having so much. I think the heel digging business I'd like to know how that works out because it might be really helpful in ethics consults. If you can figure out how to get people to undig their heels. Right. Thank you.