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Recent randomized controlled trials have shown that routine perioperative palliative care does not improve outcomes for patients undergoing curative-intent cancer surgery. No, that wasn’t a typo. Regardless of how the data were analyzed, the findings remained consistent: perioperative palliative care DID NOT improve outcomes in the only two randomized controlled trials conducted in this area—the SCOPE and PERIOP-PC trials.

Null trials like these often receive less attention in academic and clinical settings, but they can be profoundly practice-changing. Consider the Shannon Carson study on palliative care for chronically critically ill patients. While some have argued it “wasn’t a palliative care study,” I’ve always regarded it as one of the most significant studies for understanding not what works—but what doesn’t—for palliative care in specific patient populations.

The same holds true for the SCOPE and PERIOP-PC trials. Both were null, but their findings are deeply relevant to clinical practice. That’s why we invited the lead authors, Rebecca Aslakson (PERIOP-PC) and Myrick “Ricky” Shinall (SCOPE), to share insights into what they did in their studies and why they think they got the results that they did.

One key takeaway for me from this discussion was the idea that patients undergoing curative-intent surgery might simply be too early in their cancer trajectory to derive meaningful benefits from palliative care, and maybe the focus should be more on geriatrics. I especially appreciated the closing discussion about the future of research in this area: if routine perioperative palliative care doesn’t improve outcomes, what should the next generation of studies focus on?

Eric Widera

 

Studies we talk about during the podcast

      

** This podcast is not CME eligible. To learn more about CME for other GeriPal episodes, click here.

 

 


 

 

Eric 00:40

Welcome to the Jerry Powell Podcast. This is Eric Widera.

Alex 00:45

This is Alex Smith.

Eric 00:46

And Alex, we’re doing an episode today on specialty palliative care in cancer surgery. Who do we have with us?

Alex 00:54

We are delighted to welcome Ricky Shinall, who is a general surgeon and palliative care doc and associate professor of surgery at Vanderbilt. And this is, Ricky, I think your second time on the podcast. Is that right, Ricky?

Ricky 01:05

It is. Thank you for having me back.

Alex 01:07

Yeah, welcome back. And we’re also delighted to welcome Rebecca Aslakson, who’s a critical care anesthesiologist and palliative care doc and chair of the department of anesthesiology at the University of Vanderbilt. I think this is your first time on the podcast, which is long overdue.

Rebecca 01:21

Thank you for having me.

Eric 01:30

So we got a ton to talk about. I’m going to throw this out there because this is after reading, because Ricky and Rebecca both published articles randomized control studies in palliative cancer surgery. And man, after reading both of them, kind of my take home was…

Eric 01:48

…it does not look like routine perioperative palliative care improves outcomes for patients. We’re going to be talking about that. But before we jump into that, Rebecca, do you have a song request for Alex?

Rebecca 02:01

I do. We are. Although this may be broadcast in late January or February, it’s early January when we’re recording it. So we just finished the holiday season and I want to promote one of the best holiday songs ever, which is the Fairy Tale of New York by the Popes. And it’s also one of those songs that simultaneously holds both sadness and hope. And I think that’s a good thing when you think about surgical palliative care, that sometimes there’s a little darkness and sadness, but then there’s also hope at the same time.

Eric 02:29

I love it.

Alex 02:30

Here’s a little bit.

Alex 02:35

(singing)

Eric 03:18

Thank you, Alex. I am really excited to ask some of my last questions when I think about the future of surgical palliative care based on that song. But we’re gonna hold off on that till the last question. So, listeners, you gotta listen the whole episode.

Alex 03:32

Oh, yeah.

Eric 03:33

I’m going turn to you to start off with both of you to think about this question is like, what motivated you? Like a randomized controlled trial. That’s you just tons of effort. Right. I’m gonna start with Ricky. Like, what motivated you to. To do this study as a surgeon?

Rebecca 03:51

Yeah.

Ricky 03:51

So really, I think what motivated me to do it as a surgeon was this was really what got me interested in palliative care as a surgeon was the randomized control trials that had been done in this field in medical, on ecology settings. You know, we had people like Maureen Bakitas and Jennifer Temel who had done these really groundbreaking studies.

You know, now it’s. It’s been, you know, a decade and a half ago that showed that that specialist palliative care concurrent with active cancer therapy not only gave good palliative care outcomes, but gave good cancer outcomes and in some cases, prolonged survival. And it as a surgeon who was going into palliative care, this was very exciting to me. And thinking about, you know, could the same things that were happening to the medical oncology patients, could this happen to surgical patients?

And there was no retrospective way to find evidence for that, because this was not something that some surgeons were really doing in any big enough numbers to get evidence for. And so, you know, we had. We had good evidence in a very similar population. Really, the only way to find evidence in the population that was my clinical interest was to conduct a randomized control trial. And so that’s what I decided to do.

Eric 05:14

That’s amazing. Rebecca, same question for you.

Rebecca 05:18

So it was a different journey for me. So pretty much all of my work, its roots are in the intensive care unit. So I was doing my PhD research work integrating palliative care in the ICU and there was. The core intervention had come out of a MICU and we integrated. I worked exclusively in surgical ICUs. All my patients were surgical. So I integrated it in a SICU and it really didn’t work. Like wheels coming off the bus, it didn’t work.

Eric 05:46

Why?

Rebecca 05:48

What works in a MICU doesn’t work in a SICU? What works for a medical ICU which was a closed medical ICU with four or five physicians and 20 nurses and some house staff, did not work in a semi open administrative ICU with 40 some surgeons and 10 ICU physicians and 20 nurses. It just, it really didn’t work. We could go into more detail. I wrote a whole paper about that. It’s really hard to get papers published of negative pilot trials by the way, but, but it really didn’t work.

And that became the foundation for my career development award from National Palliative Care Research center and the foundation for Anesthesia Education. Because then we did a qualitative study in surgical ICUs about like, what is palliative care? Like what is it? What should it be done? What’s your understanding of it? And we interviewed patients, their family members, their surgeons, their intensivists and their nurse. And we went back and we re interviewed patients again and family members at 6 and 12 months. And what we heard from patients and family members is they expected everything, but not this.

Surgeons told them about all that could happen and they didn’t expect to be stuck in an icu. And what we really looked at is we said, gosh, that’s, that’s a deficit of advanced care planning. People thought there were two options. Either you’re going to get surgery and it’s maybe going to be hard for a little bit, but you’ll progressively get better and such. Or option two is you’re going to die on the operating room table and you don’t work in surgery very long. And Ricky can speak better unless you’re talking like trauma or ruptured AAA’s. Very few people die on the operating room table. If they die, it’s in the days to weeks to months afterwards where they just can’t get better. They just can’t get out of the icu. So there’s a bucket, three patients families didn’t know about.

So that spurred my first PCORI funded award which was to do advanced care planning. It was in collaboration with Angela Valandis doing video based advanced care planning for surgical patients. Which means you’re going to have to, I started in the surgical ICU and you need to talk to them before they hit the surgical icu, which means you have to talk to them before the surgery. So that pushed my research work into the preoperative space. And I started to collaborate with cancer surgeons because they were the ones who were most open to doing this work. And so we collaborated with them and we did Peak Corey where we integrated a video based advanced care planning tool. And we people said, you can’t do this. We could have a whole talk about this.

But we did. We were successful. We were able to do it. It didn’t have an impact. It was a negative trial. And then when we did the follow up from that and there was some data that had come out from med onc at the time with patients and families saying, you know, I don’t want to have these discussions with my surgeon about. When they talked about medical oncologists, about half said, yeah, I want to talk about advanced care planning with my medical oncologist. The other half said, I want to talk about it with anybody but my medical oncologist.

And we found the same thing when we talked to surgical patients that some really didn’t want to talk about this with their surgeon. That’s not who they wanted to have this conversation. So we did stakeholder summits and we said, well, who should be the person that has the conversation? And that’s where came the idea of it should maybe be a palliative care practitioner. And that’s how we then launched into this trial because we said, well, you don’t want to talk to your surgeon, so let’s do surgeon palliative care team co management.

And then that gives somebody else who could and having this conversation, maybe they can do some symptom management. And we really mirrored it after Jennifer Temel’s 2010 trial in medical oncology. When you’re talking about outcomes or anything like that, we said, how do we pick that up out of medical oncology and put it in surgical oncology? And Jennifer was one of the consultants on our project who worked with us throughout the whole trial. She’s amazing because we really were trying to do her study in a surgical oncology. So that’s the preceding. And it was about 10 years of work that proceeded before we could really start the rct. Wow.

Eric 09:35

Well, I got a big picture question I want to ask you, Ricky, is it feels like we actually have a fair amount of data on palliative care and medical oncology. Aside from your two studies, I can’t think of another randomized controlled study in the surgical oncology setting. Why do you think that is?

Ricky 09:54

Well, I think the surgical oncology setting was sort of a step even earlier in the cancer treatment paradigm than where medical oncology is. Right. So if you think about the study that Rebecca mentioned, Jennifer Temel study, those were with patients who had incurable non small cell lung cancer. Right. So those are patients that have incurable disease that they’re getting life prolonging treatment for, but not curative treatment for.

Eric 10:25

But we do have studies like in hemologic stem cell transplant patients, curative studies showing benefits.

Ricky 10:34

But that was a, that was a step upstream from there.

Eric 10:37

Right.

Ricky 10:37

And so this is similarly a step upstream from that. So I think we have, you know, we are progressively moving in our studies kind of upstream and seeing at each step. Does palliative care have measurable benefits at this point, even earlier in the cancer care continuum? I think when you, when you hit on and it does, then that generates more and more studies at that point. And then you move a little bit further upstream and say does it have benefits at this point?

Rebecca 11:04

And absolutely. To get our funding from PCORI. Cause our, our, the multi site was funded by PCORI. I mean we, we absolutely cited Tom LeBlanc and Ariz El Jawahari in those hematopoietic stem cell trials like th. Those were absolutely saying like hey, this is, you know, these are curative intent treatments and this is why this could also work in surgery. And to clarify too, these are actually. Ricky, feel free to jump in.

But to my knowledge these are the two first trials to integrate palliative care subspecialists in the perioperative period, full stop. Not just surgical oncology, all of surgery. And I think I know Ricky feels that. Ricky and I also talked monthly throughout the whole period of our trial because we always said our goal is that we finish with two trials that are really strong and we support each other and we learn from each other. So we were talking throughout the whole time. But yeah, I mean this is.

Eric 11:52

Let’s jump into it then. Let’s start off with your study, Rebecca. Was it periopath PC? Was that the periop PC? So what I remember from it, it was surgical teams that can do PRN consultations of palliative care versus integrated kind of palliative care in the perioperative setting.

Alex 12:15

Specialist palliative care, specialist palliative care.

Eric 12:18

And you focused on upper GI cancers where it was potentially curative. So let’s talk about that. Why that patient population?

Rebecca 12:27

So my initial trial, that advanced care planning trial that had been in all of surgical oncology and we had specifically said, anybody who needs to go to the ICU afterwards, if your surgery is big enough that you need to go to the ICU afterwards, it’s time to have a conversation.

Eric 12:41

Take out those cataract surgeries. Take out those.

Rebecca 12:44

But, like, we included, like, pelvic exaggerations. Like, we actually had a fair amount of gynoc patients in that first trial. And then when this is actually, I can remember the conversation I had with Jennifer Temel, and when we were trying to get PeriOPC funded, she said, rebecca, you’re going to have to live a little bit more in the cancer world. And in the cancer world, you have to have that fine line. It could be a pragmatic trial, but you have to be clear in your patient population clearer than what you’ve been up to this point. And so choose a patient population. And we went with upper GI cancers. Everybody could agree on that.

Those were the surgeons who were willing. Gynox surgeons. Wonderful. They were willing to do a lot, but we thought that was a critical mass. And our prototypical patient had pancreatic adenocarcinoma, and they were going for a Whipple.

Eric 13:28

And so these are people with some palliative care needs. They got symptoms. It’s a big surgery. It doesn’t always go well.

Alex 13:36

Painless.

Rebecca 13:36

John thing, though, is that we had to train our palliative care clinicians in the trial because they had different preconceptions about these patients that we had to actually, we worked with Allison Cook Chapman, who was at Stanford at the time. She’s at UCSF right now to develop materials to prep the palliative care clinicians because they would think pancreatic cancer, six months. Yeah, this is all bad. And we had to tell them, you don’t understand.

These patients are, like, going to be feeling lucky and excited because they’re the subset of pancreatic cancer patients that still have curative intent options. So they’re going to be feeling lucky and upbeat, and it’s going to be different than what you think about in your normal palliative care practice. So we actually had to work very closely with our palliative care clinicians at all the sites to get to do these PeriOPC consults, because it’s a different patient population than they were used to.

Eric 14:31

And can you walk us through what a typical palliative care intervention looked like in your study? Like, what was that?

Rebecca 14:39

Are you ready?

Alex 14:40

Composition and contentious.

Eric 14:44

Yes.

Rebecca 14:46

We had a lot of discussion about this, and you guys don’t realize that you were at the root, I can blame the tweet.

Alex 14:53

Please do.

Rebecca 14:55

So we had a lot of discussion because we had dissent amongst the palliative care leaders on the team about how protocolized it should be, whether it should be a protocolized intervention. You’re going to talk about this and you’re going to talk about this and you’re going to talk about this. And the thing that caused us to not. And there were some people, I will not name names, who felt very strongly that that’s what it should be.

And there were others who, based on the Shannon Carson’s chronic critical illness trial, which you guys had a Jerry Powell podcast about, In N Out Burger, In N Out Palliative care that criticized saying it wasn’t palliative care necessarily. And I knew people that had been involved with that. That was a palliative care trial in the icu. And when I talked with folks, they said it was protocolized and they said I was forced to do things I wouldn’t normally do. Yeah, I usually figure out where patients and families are.

I meet them where they are, and I tailor my palliative care and what I do based on where they are and what they need. And so we didn’t choose to do protocolized palliative care because we didn’t want to force that. We knew a lot of the patients and families were going to be in different places with what they were willing to talk about. And so we said we are. We only had four main components for the palliative care. I have to think about it. Now is time at least an hour a month. It had to be multidisciplinary and really meaning I have to go back and think again. It’s like four things. Basic things.

Eric 16:17

I gotta say, though, I do love that I chronic critical. I think of the articles that I think most important in palliative care. I would actually say that article is probably more important to me than Jennifer Tamel’s article because the article that we. Yeah, and it was not a knock against the article. It was because we’ve all kind of done that. And I think in a lot of our practices, we almost force that. We try to do these standardized notes and things like this.

And for me, that was more practice changing of an article than the Jennifer Tamel article. I know the Jennifer Tamel article is great to push palliative care, but to also say, like, huh, maybe this shouldn’t be our practice. And that’s why I really loved your two articles too, is sometimes we actually learn more from negative articles than Positive ones. Yeah.

Rebecca 17:10

So we didn’t protocolize it. We didn’t. We said, you’re a palliative care clinician. We trust you. What to do, what you think is appropriate. Here are the, you know, four things to incorporate. One of them was like a symptom assessment. You gotta do a symptom assessment. It was really just four very basic things. And we used. Then Jennifer Temel, she had a study. So what we did then is whenever a palliative care clinician interacted with somebody, that palliative care clinician filled out a survey, and through that we figured out what was in the syringe. And then we incorporated that in the final study to say kind of what was done and such.

Ricky 17:45

Yeah, I mean, we had a similar approach where we essentially said, these are the types of things that you have to do, but not exactly how to do them. And we set it up so that, you know, the notes would be templated so that we could go back and say, did. Was this addressed. Was that addressed very similar things of, you know, illness understanding, assessing whether there’s any advanced care planning, those sorts of stuff.

Eric 18:10

Relationship and rapport building. It felt very like Jennifer Tamel, qualitative study. Like, very similar things.

Alex 18:17

Right.

Ricky 18:17

But not. But not a. Like cookbook of. Here’s what the palliative care consultation is.

Rebecca 18:22

And it was specifically because of the Carson’s trial. It was specifically because of that. Because there were a few people very much wanted to protocolize it, and we absolutely went against them. And we.

Eric 18:31

Yeah, I actually think that that was a pal. I know a lot of people say that’s not a palp care study. I think it was a pal care study. Again, I think it was one of the most important ones. I gotta ask primary endpoints. Cause both of you chose, if I remember correctly, the facet pal. So quality of life, why that? Cause the other thing that always comes up is you can look at utilization data, hospitalizations, icu, length of stay. Why did you choose a quality of life outcome?

Rebecca 19:00

You wanna go first, Ricky?

Ricky 19:01

Yeah, sure. So two reasons. So one reason is when I’m seeing people as a palliative care consultation, I introduce palliative care. As I say, we’re doctors that focus on improving the quality of life of patients with serious illnesses. Right. So in my mind, if that’s how I think of what my specialty does, then measuring success of what a palliative care intervention does should probably be quality of life. That was one.

The second was that the studies that we’ve mentioned, like Jennifer Temel’s, study that have shown the impact in the medical oncology settings. That was generally the primary outcome in those studies. And so wanting to set your studies up for success, saying, well, what have similar studies shown impact? And this was it. So that was, that was what guided my choice.

Rebecca 19:54

Mine are very similar. Um, Jen, as I said already, Jennifer Temel was one of our consultants and so her trial used Fact L because she was using lung cancer patients. We had, there’s no like facet upper GI cancers. So we. James Tulsky was involved and I remember it was him who said, let’s use facet pal. Like that actually has everything you want. And then we can pull fact G out of it as well. And then also too, it’s really interesting because we were funded in 2017 and right after we were funded, PCORI funded a whole cadre of palliative care trials, about five or six of them.

And then they compiled us together to make the palliative care learning network and collaborative. And we’d meet regularly. And one of the very first thing it was a meeting in October of 2017. They brought us together in D.C. and they said, where your outcomes are different, we’d like them to be similar so that we have a body of work and you can compare similar outcomes across trials. Like we had gotten, we were going to use had score for psychological distress. And because of that we moved instead to Promis 29 and using the mental health subset of that because it was coordinating it across all of the PCORI funded palliative care trials.

The only person who didn’t change the outcomes significantly or not significant to a certain extent was Jennifer Temel and Joe Greer because they said they couldn’t because they’re comparing against their previous work. So they needed to use the same outcomes over time. But a number of us did change some of our outcomes so that they would be similar across this whole body of work of PCORI funded trials.

Eric 21:26

So let me ask a quick question. I don’t want to get too wonky, but you both had facet as the primary outcome, but you looked at a little different component. I think, Rebecca, you had, you used the full facet pal, which includes things that I wonder how much do I actually am able to change. Questions like I am able to work, my work is fulfilling. I have accepted my illness, especially in this population. So that’s under the funk. The social wellbeing, I believe social family wellbeing versus Ricky. You mainly focused on, I think three components of the facet function.

Ricky 22:02

Yeah, the physical and functional subcomponents Why’d you do that? Called the trial outcome index. Yeah, so. So when we were. Were sort of putting the. The trial together, and we were kind of doing the brainstorming of what the. The outcomes were gonna be, we kind of had sort of two buckets of the types of outcomes. You had the sort of what I would describe as the kind of softer outcomes, like, you know, quality of life, the psychosocial outcomes.

The outcomes would be very important in a palliative care setting and be very, very impactful to a palliative care community. What I would describe as the sort of harder outcomes like utilization, complications, mortality, morbidity, the things that I think would be more impactful to surgeons and thinking through this, ultimately, had this been a positive trial, thinking, well, the behavior that we would want to change would be the behavior of surgeons or bring palliative care consults.

Right. And so I want my primary outcome to be. If it can’t be one of those hard outcomes, I want it to be the soft outcome that’s, like, the closest to that. And so that trial outcome index was among those. Those outcomes that kind of got you closer to the things that, you know, a surgeon, I think, would find most meaningful had it been positive. And that I thought would mo be most likely to move the needle for changing surgeon behaviors rather than a change in sort of overall quality of life.

Rebecca 23:36

Yeah. And I think for me, a lot of it. I mean, I’m really rooted in the critical care literature and palliative care in the icu, and I deeply am moved by Chris Cox’s work, who’s at Duke and been there for many years. And he talks about how hard it is for people to return to work after long ICU stays after major illnesses and such. And so I got to say, those outcomes have always interested me because I think they’re understudied. And so. And then also, too, I mean, James Tulsky is a bright guy when he goes, I think this is the one you want to do. I’m going to think really hard before I disagree with him. He’s done a few trials. He kind of knows his way around.

Eric 24:14

All right, so I started off podcast saying, routine perioperative palliative care does not improve outcomes in patients undergoing potentially curative.

Rebecca 24:23

Intense, Curative, intense surgeries. Is that.

Eric 24:26

Wait, Ricky, yours was curative intent, too?

Alex 24:29

Yes.

Rebecca 24:30

Yes.

Eric 24:31

So not like palliative surgeries, but curative, intense surgeries. Is that true? Is that what you found?

Ricky 24:37

I would say so.

Eric 24:39

Was there any subpopulation? Any.

Ricky 24:41

Nothing.

Eric 24:42

Of effect?

Ricky 24:44

Not that we could find. I mean, we’ve. We have tried to slice our data. We’ve looked at, well, maybe, maybe it was the people who. Who were worse at baseline or who had bigger operations, or maybe the effect doesn’t show up T or this, that and the other. In every way we looked at it, we can’t find a significant change. And that also matches up with kind of what we see in the qualitative data where we talked with a subset of the patients about a month after their operation to find out what was going on. And the ones that had the palliative care consultation liked it, but couldn’t really remember anything specific that it did for them.

Couldn’t sort of say, like, oh, well, this is. It really helped me with X, Y or Z. They just, you know, they liked it and found it generally supportive. So I think that your statement, Eric, is an accurate representation of what we found.

Alex 25:36

And can we just stick with Ricky for a moment? Ricky, was there variation by palliative care.

Ricky 25:43

Provider in terms of how effective it was? Yeah, so we didn’t have enough, you know, enough different palliative care providers to really look at that. So that really, the biggest difference between Rebecca’s study and my study was the amount of money involved. So my. Mine was a much smaller study. So it was only at a single center. And honestly, it was. A lot of the intervention was me doing the intervention. So there was not enough variation in who was doing the intervention to really test the effect. And honestly, one of the best things about having Rebecca do this trial was it removed. One possible interpretation of my trial was that I am just not very good at palliative care by. So. So thank you, Rebecca, for. For saving my. My professional ego.

Rebecca 26:37

I’m here for you, Ricky. We’re here for each other. Anesthesia surgery, you know, we gotta take care of each other.

Ricky 26:41

That’s right.

Alex 26:42

And I think, like, if you wanted to have a palliative care specialist do this, the ideal palliative care specialist is someone who you don’t have to teach about, you know, this surgical palliative care is different. Like, Ricky is the terrific optimal sort of palliative care specialist to do this.

Ricky 26:57

And I mean, I was actually. This was one of my concerns. If. If the trial had been positive that this was going to be one of the.

Eric 27:04

Right.

Ricky 27:05

If my trial. My trial had been positive, that that would have been one of the critiques. Well, it’s like, well, this only works.

Eric 27:10

Yeah, you need Ricky.

Ricky 27:11

If you have a surgeon who’s a palliative career doctor who’s doing all of this. This is not externally valid. Turns out even if you have a surgeon who’s a palliative care doctor, it doesn’t affect these outcomes. And in Rebecca’s study, it’s, it’s not just him, it’s a set of very skilled palliative care clinicians in a number of institutions.

Alex 27:29

But we just stick it with this. One more question. You know, we often invite the somebody who’s like on the trial delivering the intervention to ask them if they thought that this intervention was going to work. Did you feel that, like you were helping people in ways that would either move the needle on the outcomes you assessed or move the needle in ways in which you weren’t assessing outcome, another outcome.

Ricky 27:51

So my, my gut feeling about a year into the trial was that it was going to be a null trial. But the thing about, the thing about trials is that you are doing them because the potential effect is subtle. Right? Like you didn’t do a randomized controlled trial of penicillin when it was discovered because it just like worked and it was so obvious. Right? And so that was always the caveat in the back of my mind is like, this could be working and it’s subtle and that’s why we’re doing a trial about it. And yeah, if it had been obvious, we wouldn’t have done a trial. Someone would’ve just done it in clinical practice and it would’ve been obvious and it would’ve worked. So that was, that was the back of my mind.

Rebecca 28:32

I have to, in the midst of this too, the patient population changed. This is something I don’t think a lot of people appreciate. When, when we started to try to get this trial funded, median survival after your pro or prototypical patient, pancreatic adenocarcinoma, getting a Whipple. Median survival after successful surgery was 20 months. That’s what we put in, that’s what we got funded on and such. And in the meanwhile, the drug Fulfirnox came out, which is great. That’s wonderful. It’s, it’s extended survival for these patients, but instead of a 20 month survival, now it’s like a four to five year survival.

And that really changed our timeline for thinking of when we might see effect, because we initially thought we were going to have some patients approaching end of life not that long after the trial, but now it was going to be four to five years out. And so it really, that changed. That changed in the middle of the trial. When did full fear next come out? It was like, 2017, 2018, Ricky.

Alex 29:27

It was like, around then.

Ricky 29:28

Yeah. And I mean, you know. Yeah. I mean, we. We followed our patients for three years in the trial, and it was, you know, we had kind of a more heterogeneous mix, but we sort of guesstimated that that would be around, like, the median survival for the folks. And it turns out only like, a third of the patients that we. That have died in that time. So, again, the cancer, thank goodness, is undergoing a change in the prognosis that just changes what it means to provide palliative care to these people.

Eric 29:59

So let me. I’m gonna bring up some of the same cheeks that were brought up against Carson article. Why it may have not been your palliative care study. Like, one critique I’ll throw out is this was not the full palliative care in a professional team. Well, for your study, Ricky, I wanted to ask about, like, who was on this team for your study, Ricky?

Ricky 30:19

For my study, it was. It was me or one of my partners sort of doing the intervention and then involving the interdisciplinary team, like when we detected needs.

Eric 30:27

So you had access to the full team, right?

Ricky 30:29

Yeah. So, I mean, you know, if it. So I would. If I was doing the intervention and I. And I detected, you know, there was some family systems issue or there was something else that. That I felt our. Our palliative care social worker could help with, I would engage them, or I felt that, you know, kind of spiritual or existential distress was part of the. The patient’s total pain experience. Then I would access them. But that wasn’t sort of protocolized as part of the intervention.

But honestly, that’s not how. At least at Vanderbilt, we practice on our consultation side. Right. Like, the way that we do this is the way that we do palliative care consultation. Right. Is that the clinicians consult, and then they involve the other members of the IDT as they detect issues. So this was, you know, consistent with our practice of palliative care consultation.

Eric 31:18

Same for you, Rebecca.

Ricky 31:19

Involved the idt.

Rebecca 31:20

Yeah, I mean, folks, we could talk about COVID too, because our folks got just clocked into the palliative care team at whatever site it was. The Brigham for Johns Hopkins, University of New Mexico, and then Ohio State got added later in the study. So it was sometimes the primary clinician in palliative care was a nurse, a nurse practitioner, sometimes it was a physician, and they were just part of the interdisciplinary team.

The consults in pre op were done in. When the study first started, they were mostly done in Person in the preoperative clinic because a lot of these patients for these surgeries come in for testing beforehand because these are really big surgeries. It got moved to virtual during COVID But even during COVID the one week as folks saw palliative care before surgery, one week within the first week after surgery, one month after surgery, two months and three months after surgery. And that one week within one week, that was always a consult that was in the hospital with the patient in the hospital with the consult palliative care team for, for the hospital.

Eric 32:23

Very pragmatic. Like this sounds like what Ricky was saying, what we do in real life. So that argument gets thrown out of the water. What about the argument was, huh. Like, was it that these individuals just like when I. I don’t know enough about the facet, pal. But the numbers didn’t look very low. Like did these people have much as far as palliative care needs or no?

Alex 32:46

No.

Rebecca 32:46

So when we first showed our data to Jennifer Temel, she goes, your people are feeling pretty good.

Rebecca 32:55

It’s hard to show a benefit to improve quality of life when they feel pretty good because that’s the thing where hindsight’s 20 20. These folks aren’t getting these big surgeries if their ECOCHG score is low, if their functionality is poor. They are not getting offered a Whipple. They are not getting offered these big esophagectectomies. So their functionality has to be pretty good. They felt crappy one week after surgery because these are big surgeries, but they slowly recover. And so when you’re starting, it’s hard to show an improvement of quality of life when folks are starting at a pretty high number.

Eric 33:26

The interesting thing I’m going to go to your article, Rebecca, was I was thinking it was going to look like the stem cell transplant paper where, you know, symptoms were bad during the month of stem cell transplant, but then they got better. You actually, I think it was your article actually showed like timing of the quality of life and there’s really no difference throughout the whole time of quality of life.

Rebecca 33:52

No, it’s not. Well, look, if you look particularly at physical functioning score, it definitely takes a dip.

Eric 33:57

Yeah, there was, there was a dive. But both groups looked.

Rebecca 34:00

Oh yeah. No, they, they were the same. There was no difference between the two. Yeah, stayed the same. They, they stayed kind of lockstep the whole way through, which gets into. I’m a deep believer in mixed method studies and that you can’t really understand especially nuanced trials like this without the qualitative so we had been doing qualitative the whole way through. We did qualitative with folks before for surgery one week after, you know, months and months we did with the clinicians, with family members and such.

And we kind of got an appreciation early on that people were very much on the care train. Like, it took up all of their mental bandwidth just to be like, whoa, I have pancreatic cancer. Wait, I have, I can, I can still have surgery, I can still have cure and I’m going to have surgery. Like, that took up their entire mental plate and there wasn’t space for other things. We did have some anecdotal with patients and family members saying, hey, there was somebody here who could talk to me about this because I was ready to talk about it.

But a lot of them are really heavily on the care train and, and they’re like, you know, come talk to me when, when I’m not in cure mode anymore. And there wasn’t a lot of space in cure mode to think about other things, about what if it’s not what you want. We did have early on an anecdotal case where the family member reached out to our, our study team like, like a couple months after their six month mark because we, we stopped following people after six months. And she said, my husband just had a interaction with their surgeon. The news wasn’t good. How can I talk to that doctor?

So and so again, because he won’t talk to me. He doesn’t want to talk to anybody else, but he wants to talk to the doctor. So and so that was the palliative care doctor. So that person. And we had people who had said, can you follow up? And maybe, maybe the intervention you’re going to see is these people who are exposed to palliative care really early when their disease comes back, they’re going to be more likely to pick it up and to not resist it or to want it involved when they’re at a later stage. Initially we thought we could do that trial, but now when the people were living so much longer afterwards, there was no way we could incorporate that in.

Eric 35:58

Did you see in your qualitative study? Same thing with Ricky is people liked it, but they weren’t sure what palliative care did.

Rebecca 36:06

Yeah, yeah, we have a whole paper. Laura Holdsworth did the. Is the first and we’ll have links.

Eric 36:12

To that on our show notes.

Alex 36:13

And how about the providers? Did the palliative care providers feel like they were being helpful?

Rebecca 36:19

They, again, they had. They had to get used to the fact that it was a different patient population, but yet, no, we got pretty early on that they didn’t feel like they were able to do a whole bunch. There were some interesting things, like people who had, like, peripheral neuropathy and things related to previous chemo that they had had where the surgeon was like, I didn’t know palliative care could help with this. This is great. We actually saw an anecdotal uptick of just consults for palliative care from surgeons, not on trial patients, but just on patients in general that they got to know. The palliative care team saw the benefit so pretty.

I’m a believer that research itself can change culture and change practice. And we saw it at each place we ran the trial that palliative care was just consulted more by surgery because they kind of got to know the practitioners and trusted it, and they did see some patients that were helped by it. What’s interesting is when you look at the different sites in our trial, in the control arm, they could. They could consult palliative care if they wanted to. And there were some sites where there was zero consulted palliative care. And there was our biggest enrollment site where about. I think it was about a third or a quarter of the patients in the control arm consulted.

The surgeons consulted palliative care for those patients in the control arm. And so that could have been something that could have certainly biases you towards the null because you’re.

Eric 37:37

Did that happen in yours, Ricky?

Ricky 37:39

Now, we had one patient in our usual care.

Eric 37:43

I think that throws out that, too.

Ricky 37:46

Yeah.

Eric 37:47

All right, Ricky, I got a question for you.

Ricky 37:48

Yeah.

Eric 37:49

You have a fellow surgeon listening to this podcast. He reads your article, like, based on this research, but yours and Rebecca’s. What are you going to tell them if. If ever, like, should we never call valve care? Like, when. When do you consult palliative care as a surgeon, knowing what you just did?

Ricky 38:08

So I think as a surgeon, I think for a preoperative patient, you consult palliative care when somebody’s not sure that it’s a good idea to operate on the patient. And that somebody could be you as the surgeon. It could be the patient or one of their family members. It could be the anesthesiologist who’s not sure that they want to put this patient to sleep for this operation. But there is some desensus in the ranks of whether or not this patient really should go to the or.

I think in those situations, a palliative care consultation can be helpful if the surgeon doesn’t have the bandwidth or the wherewithal to sort of like, sort this out themselves. If this needs a bigger discussion about what the goals of the surgery are in relation to the larger goals of the patient’s care and whether the patient really sort of understands the risks and is undertaking them sort of in congruence with their overall goals. I think palliative care can be very helpful in those situations. But for the most part, patients that are undergoing these operations are not in that situation. As Rebecca said, these patients are generally doing pretty well relative to what we in palliative care think of as how patients are doing. Right.

These patients have much higher physical functioning than the sort of patients that you’re used to dealing with in palliative care. There’s really not much decision making that needs to go into whether or not you want to try to get cured of your cancer. And so for most of these patients, the involvement of a palliative care specialist is just going to be overkill.

Eric 39:46

What would you say to your fellow anesthesiologists and surgeons, Rebecca?

Rebecca 39:52

Anesthesiologist? Surgeons would be awesome. But I think first, I think I really want to emphasize, I can’t speak for Ricky, but certainly in my career, I had so many people going, you can’t do palliative care and surgery like, you just can’t. It’s not possible. So I always laugh, and I think Ricky and I have talked about this. I think a big benefit of our trial is we did them and there was no harm. No one’s head popped off because of having a palliative care surgery.

Eric 40:19

It didn’t hurt patients. It didn’t hurt physicians. Physicians. Surgeons liked it, right?

Rebecca 40:23

They liked it.

Ricky 40:24

No one said, I don’t want to do my curative cancer surgery because I talk.

Rebecca 40:29

But people were worried about that. You know, when we started, I laugh because, I mean, I’m a critical care anesthesiologist. I have put lines and tubes in places where lines and tubes should not be. And yet the only time I have been pulled out of a patient’s room because what I am doing was so dangerous, they had to run in and pull me out at that moment.

When palliative care consult with a vascular surgery patient in the SICU, where I was like, literally, like, yanked out of the room, you know, so, like, showing that it’s feasible, it’s safe, this wasn’t the right population that’s likely to benefit, but I guarantee there is a surgical population out there.

Eric 41:05

Well, let me ask you about that, Rebecca, because I saw that you were. I Think second author on a cross sectional study looking at palliative care consultations. Again, it was a, you know, observational study, a better overall end of life care communication support for patients and families who died or not the patient. The families didn’t die within 90 days of a high risk surgery, but the patients died. So it was retrospective.

Rebecca 41:30

Yep.

Eric 41:30

Like, is that just because it’s observational study and like there’s biases and you don’t know? Do you actually think like there’s a specific population? Go ahead, Alex, what you’re going to say?

Alex 41:39

I was just going to clarify. That’s not a secondary analysis of your trial.

Rebecca 41:43

No.

Alex 41:43

Different population.

Rebecca 41:45

Yeah. Yefimova et al. It was in JAMA Network Open. Ria Yefimova is the first author. It was looking at a large VA database. I did it in collaborating with Carl Lorenz and the VA clerk. So because it was a VA database. Yeah. I think there is a population out there that can benefit and such.

It’s not curative intent cancer surgeries, but this is the first step that this is the population we could do this RCT in. We had willing people, we could do it. It showed that it’s feasible, nobody got hurt. And then other trials in surgery can now happen because of the trials that.

Eric 42:17

Okay, my last question then to both of you is what, what would like, okay, you have some billionaire listening to this podcast and they’re going to fund any trial that you want to fund. Like what, what’s that next study look like for you, Rebecca? What’s it for you?

Rebecca 42:34

I think looking at specific patient populations that are starting with very low health related quality of life, often related into their surgical disease. I’m thinking about vascular surgery populations and such. I think there’s likely to be a benefit in transplant, but that is a whole separate population that is never going to be the first trial you’re going to do this in. But specifically surgical populations with diseases that themselves impair quality of life and where the surgery is a management part of the disease. And that’s why I think vascular surgery is a good first place.

Eric 43:05

Great. How about you, Ricky?

Ricky 43:07

I’ve got two. I would say after surgery for the patients when things have started to fall apart.

Alex 43:14

Yeah.

Ricky 43:15

And the second is actually the other half of your podcast name is geriatrics in an older population rather than palliative care. I think that in the qualitative work, I think the things that I heard that people needed was not so much what I would would think of as, as palliative care needs, but more geriatric needs.

Eric 43:36

I love that.

Alex 43:37

Love that.

Eric 43:38

We’ll have links to a show notes that we’ve done episodes on geriatrics and surgery. So take a look at our show notes. I. I love both of your answers. I can definitely see a better time when all of our dreams come true.

Alex 43:54

All right, here’s the more the. The faster paced ending. Here we go.

Alex 44:02

(singing)

Eric 44:44

Ricky and Rebecca, thanks for joining us on this podcast – amazing trials.

Ricky 44:49

Thank you all so much.

Rebecca 44:50

Thank you, thank you.

Eric 44:52

And to all of our listeners, thank you for your continued support.

This episode is not CME eligible.

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