Descript BTK_PC.E2_Journal Review in Surgical Palliative Care - RCTs in Surgical Palliative Care_Recording

Speaker 1:

Hi, everyone. Welcome back to another episode of Behind the Knife with the Palliative Care Team from University of Washington. I'm Virginia Wang, joined again by Lindsey Dickerson, Ali Haruta, and Dr. Katie O'Connell. Today, as part of our first journal review, we have two exciting randomized controlled trials to discuss.

Speaker 1: Dr. O'Connell, can you share some context for why we chose to discuss these two trials?

Speaker 2: Of course!

Speaker 3: There is a body of work in the medical oncology literature that has included multiple randomized controlled trials demonstrating benefits of early palliative care for patients with lung, GI, and hematologic malignancies.

Speaker 3: Lindsay, can you

Speaker 2: tell us about the kind of benefits

Speaker 4: they have seen? Absolutely. The list is long, and we know this both from the data as well as our own clinical experiences. Benefits include improved patient quality of life, emotional well being and symptom management, decreased anxiety and hopelessness, enhanced goal concordant care, decreased caregiver burden and distress, reduced costs and

decreased utilization of non beneficial medical care at the end of life, and even prolonged survival in some populations.

Speaker 3: Similar literature previously did not exist for the surgical oncology patient population, which makes these studies unique and important. The study population in both these studies are patients undergoing non palliative abdominal surgery for cancer.

Speaker 2: Yeah, and I think as surgeons, we're especially interested in the surgical population, so looking at palliative care in this space was really interesting to us.

Speaker 2: The first trial we'll be discussing was described in the manuscript titled, Effects of Specialist Palliative Care for Patients Undergoing Major Abdominal Surgery for Cancer. This was published in JAMA Surgery this past May by author Dr. Shanal Antin. The primary objective of this single center RCT conducted at Vanderbilt was to determine the effect of a specialist palliative care intervention on patients undergoing abdominal cancer operations for cure

Speaker 4: or durable control of cancer.

Speaker 4: Unzi, tell us how the trial was designed. Sure, Allie, and

fair warning, I'm going to get into a few details here. Between 2018 to 2021, 235 patients were enrolled and randomized. the specialty, or usual care group in a one to one ratio with 217 of these 235 patients ultimately included in the primary analysis.

Speaker 4: In addition to usual surgical care, the specialist palliative care intervention consisted of for primary ailments. One, a pre op consultation with a palliative care physician or NP in clinic or by phone. Two, inpatient specialist palliative care provider visits at least twice weekly during the post op hospital stay.

Speaker 4: Three, follow up clinic visits or phone calls with a palliative care specialist between hospital discharge and post op day 90. And finally, an inpatient specialist palliative care visit. anytime the patient was readmitted to the hospital. Eligible surgeries included your standard list of abdominal cancer operations, including

gastrectomy, hepatectomy, pancreatectomy, colectomy or proctectomy, meeting specific criteria given the relatively lower associated morbidity with these surgeries, radical cystectomy, pelvic exteneration, and cytorejective surgery with or without a back.

Speaker 4: Ooh, that was a lot. Virginia, can you briefly tell us about the study population?

Speaker 2: Sure.

Speaker 1: So the main takeaway is that this trial focused on patients with what were deemed to be resectable, abdominal and pelvic malignancies. There are a couple of additional details to mention. So the most common malignancies were bladder, colorectal, and pancreatic cancer.

Speaker 1: About 60% of the patients in the study had stage three or four disease. And about 60 percent of the patients received neoadjuvant therapy. One thing of note is that the vast majority of all of the study participants, over 90 percent self identified as non Hispanic white. Although the study participants appear to have been distributed along a range of incomes and to a lesser extent, a range of educational levels, minority patients are

severely underrepresented in the study population.

Speaker 4: Thank you for calling our attention to that, Virginia. We'll keep this in mind as we examine the outcomes of this study and talk about it more in a bit. So let's get into the outcomes. The primary outcome was physical and functional quality of life at post update 90, which was measured by what's called the FACT G, or Functional Assessment of Cancer Therapy General, for G, Trial Outcome Index.

Speaker 4: Virginia, do you remember the four quality of life domains the FACT G assesses?

Speaker 1: I do. They are physical well being, emotional well being, social or family well being, and maybe the easiest to forget, but one of the most vitally important to patients, functional well being. That's

Speaker 4: right. And the secondary outcomes that the study was powered to assess included 90 day overall quality of life for the FACT G total score.

Speaker 4: core versus the primary outcome, which focused on just the physical and functional quality of life domains. Days alive at home until post op day 90, which means not admitted

to a hospital or seen in the emergency department and overall survival at one year. Data was analyzed using an intention to treat approach.

Speaker 2: Great. Thanks for summarizing all of that for me. So let's talk about the results. Lindsay, what's the one liner takeaway?

Speaker 4: Well, in a few words, there was no difference between groups in the primary or secondary outcomes. So specialist palliative care in the perioperative period for patients who underwent non palliative surgery for abdominal cancer did not improve quality of life or survival.

Speaker 4: But I think there are more nuances to discuss, which is why we're all here.

Speaker 2: Hmm, yeah, true. So, to reiterate, there were no statistically significant differences between the usual care and the specialty palliative care intervention group with regard to physical and functional quality of life, overall quality of life, days live at home until post op day 90, and overall survival of one year.

Speaker 2: In the results, the authors also included estimates of the Minimal Clinically Important Differences,

or MCID, from the literature. Dr. O'Connell, I wasn't super familiar with this term until I read more about it. Can you share about how it's applicable to this trial? Sure, thanks for bringing me back in. The MCID

Speaker 3: is a standard for determining the effectiveness of an intervention and measures essentially the smallest improvement that would be worthwhile or meaningful to a patient.

Speaker 3: This is an important concept in this trial because not only were there no statistically significant differences between groups, but there were also no clinically meaningful differences. However, the authors astutely pointed out that the median baseline FACT G scores for all patients in this study before the intervention was higher than what is reported for the general U.

Speaker 3: S. population. So this specific population of surgical patients may have started off with a lower palliative care need compared to other oncology or surgical patients.

In this context, it may not be surprising that the study did not find clinically important differences at 90 days as measured by the MCID.

Speaker 3: What do

Speaker 1: you guys think? Well, I think these results make sense and are not necessarily contradictory to what we know about the benefits of palliative care interventions. It stands to reason that, in order for a patient to be offered a non palliative operation, They must have a high enough baseline functional status that the surgeon believes they can tolerate a major abdominal operation without lasting negative impacts on their quality of life and functional status.

Speaker 1: Assuming appropriate patient selection for surgery, this inherently biases our study population toward patients with better functional status and quality of life compared to at least the average oncology patient, if not the general population, as the study suggested. Allie and Lindsay, what other factors do you think contributed?

Speaker 2: Yeah, this might be stating a somewhat obvious element here, but the patients in this study had less advanced cancer overall than those included

in other palliative care intervention studies. They were also relatively young, with a median age of 65. So again, these both factor into their functional status being Both better at the time of surgery and at 90 days post op, given a lower likelihood of rapid cancer progression or physical decline.

Speaker 4: I agree, Allie. I would also add that I think hope plays a critically important role here, and it's something I've thought a lot about in general, because in surgical oncology, like in palliative care, there's this balance and almost a harmony between providing hope and being realistic.

Speaker 2: Yeah, I think we're a lot more familiar with this balance in the medical oncology population, for example.

Speaker 2: It's important to be honest and realistic when disclosing serious news, like a poor prognosis, which can significantly decrease the mood and quality of life of patients. But then you also want to provide a hope that we have options to treat them as a whole person. We aren't going to abandon them, even though we can't cure their cancer, we can still help make their remaining time worthwhile to them.

Speaker 4: That's absolutely right. And I think the situation here is different from what you were just talking about in medical oncology. These patients in the surgical oncology world are going into surgery with hope for what they've been told is a curative or disease controlling surgery. So once they've recovered from the operation in the short term, their physical, social, functional, and especially emotional quality of life and well being is unsurprisingly similar to what it was preoperatively.

Speaker 4: I've personally even seen this in patients who return to clinic after a successful oncologic surgery. I

Speaker 2: think you're right. There is something about that idea of cure that brings this hope that's hard to quantify. I also just wanted to note that there is benefit demonstrated in medical oncology populations undergoing non surgical treatments with curative intent.

Speaker 2: Such as stem cell transplants. So, the opportunity for cure is not the only factor that may have contributed to the lack of effect seen in the surgical oncology population. But certainly,

the idea of cure is an important source of hope. So essentially, these patients may not have had specific palliative care needs at the time of intervention.

Speaker 2: But that doesn't mean that introducing the topic of palliative care or discussing prognosis, for example, early in the course of cancer for these patients is not beneficial. It's just a matter of how we measure the expected benefits. What do you think, Dr. O'Connell? Well,

Speaker 3: I think that selection of measurable primary outcome is really key for detecting differences in standard care versus palliative intervention studies.

Speaker 3: If the author selected quality of communication with the medical team, or advanced directive completion, or extended the duration of the study to capture recurrence of disease,

Speaker 2: which usually doesn't occur within the study

Speaker 3: period of 90 days post op, there may have been a detectable difference.

Speaker 1: One last thing before we move on from this study, I think it's important to circle back about the demographic factors that we

mentioned at the beginning of our discussion.

Speaker 1: As the authors of this paper are very well aware, 90 to 95 percent of the patients recruited for this study self identified as non Hispanic white, so racial and ethnic minority populations are vastly underrepresented here. The authors also noted that patients with higher education and the ability to travel for care, given that this study was conducted at a tertiary referral center, were overrepresented in the study population as well.

Speaker 1: Particularly since minoritized patients consistently have worse outcomes compared with non Hispanic white patients in so many different areas of health care, including oncology, more outreach is warranted to engage underrepresented minority patients and address these disparities.

Speaker 4: To that point, Virginia, there's a study by Dr.

Speaker 4: Ingersoll and colleagues that we'll include in the show notes evaluating racial and ethnic differences in prognosis communication during inpatient palliative care consults for patients with cancer. The study found, unfortunately, that prognosis communication occurred less frequently for Black and Latino patients

and included fewer optimistic cues.

Speaker 4: So, I think that the low diversity of the study is important to note, like you did. And how palliative care interventions affect outcomes for minority patients specifically wants further study. I wonder

Speaker 2: if the results of the study would be the same at other centers providing cancer care that serve different populations, although so many specialty cancer centers are tertiary referral centers, it would be difficult.

Speaker 2: Yeah,

Speaker 3: well, the majority of our audience here likely practices in academic centers where palliative care is integrated into surgical care to some extent. It is important to realize that this is novel to most non academic and rural surgery practices. So the results of palliative care studies may not therefore really be

Speaker 1: widely applicable.

Speaker 1: We'll keep these limitations in mind as we move on to our next randomized controlled trial. This trial is described in the paper Effective Perioperative Palliative Care on Health Related Quality of Life

Among Patients Undergoing Surgery for Cancer by Dr. Aslakson and colleagues, also published in May of this past year in JAMA Network Open.

Speaker 1: This was a multicenter trial that recruited patients at five sites with upper GI cancer undergoing operations with curative intent who had not previously received specialist palliative care. The majority of patients in this study had a primary pancreatic malignancy. This study's patient population also self identified as majority non Hispanic white, although minority patients were somewhat better represented in this multicenter study.

Speaker 1: A majority of all of these patients, around 70 percent in the control arm and around 60 percent in the intervention arm, had a college degree or higher. This study also recruited a slightly more even distribution of men and women. Lindsay, what else should we know about the study design? Always

Speaker 4: making me go into the details of the study design.

Speaker 4: So in addition to usual surgical care, including pre op and post op visits, patients assigned to the intervention group met either in person or via phone with a member of an interprofessional

palliative care specialist team prior to surgery. One week after surgery and one, two and three months after surgery with additional visits scheduled at the discretion of the patient surgical team or palliative care team.

Speaker 4: These specialists were either hospice and palliative medicine boarded MDs, ARNPs, social workers, pharmacists, or chaplains trained in palliative care with additional specific training about GI malignancies. The visits most often involved rapport building, symptom management, illness education, and coping with serious illness.

Speaker 4: Virginia, what was a key difference that you noticed in the usual care group for this study?

Speaker 1: Well, this study was designed so that patients in the usual care group could actually receive a palliative care consultation if the surgical team requested it. And The surgical teams were encouraged to follow NCCN recommended triggers to involve specialty palliative care consultation.

Speaker 1: All right, so what about the study outcomes?

Speaker 2: So the study utilized several

scales to assess their primary outcomes. They're listed in more detail in the show notes, so I'm not going to go into every single one, but basically they looked at health related physical and emotional quality of life and mood symptoms.

Speaker 2: They then calculated a summary score looking at several different domains. Lindsay, can you tell us what those

Speaker 4: are? Yeah, it might be hard to remember all these, but luckily I have them written here. Cognition, depression, fatigue, pain, physical, sleep, and social. That's right!

Speaker 2: So, the primary study outcome was difference in patient reported health related quality of life at three months after surgery.

Speaker 2: Exploratory subgroup analyses were planned as related to race, ethnicity, and study site. And now, the moment we've been waiting for, Virginia, take it away with the results.

Speaker 1: Well, as in the prior study, no statistically significant differences were identified between the control and intervention groups in any of the health related quality of life metrics.

Speaker 1: There were also no significant differences in mortality between the two groups. It is

interesting to see that 20 of the 177 patients randomized to the control arm were actually referred for palliative care consultations during the first three months post op, and five of the patients were referred for hospice care.

Speaker 1: Notably, one center accounted for the vast majority of these crossover referrals, and that is the same center that had the highest enrollment in the study. This demonstrates some variable practice of routine integration of palliative care into surgical treatment nationwide. Lindsay, do you want to talk a little bit about what your takeaways were from this?

Speaker 4: Sure. And I do think that's a key point in the, the difference in this control population, that, uh, the surgeons had the opportunity to refer patients for palliative care treatment and that 20 of the patients randomized to the control group were referred. So overall, like the first trial we discussed, this trial also focused on patients undergoing operations with curative intent.

Speaker 4: The authors of this study also noted that as we have more nuanced discussions about the best timing for palliative care interventions

for surgical oncology patients, the particular juncture described in both of these trials may be too early in the patient's cancer journey to measure the benefit of.

Speaker 4: Specialty or specialist palliative care engagement. And this is like what you touched on earlier, Dr. O'Connell. I'm curious to hear what additional thoughts you might have.

Speaker 3: Overall, it seems that it may be more difficult to demonstrate a measurable impact of specialty palliative care engagement at this time point

Speaker 2: for patients with higher baseline quality of

Speaker 3: life and milder cancer related symptoms.

Speaker 3: Even if they have a serious diagnosis like an upper GI malignancy requiring major abdominal

Speaker 1: surgery. I also noticed that 119 eligible patients actually declined to participate in this study. And the most common reasons they gave for declining to participate included being too overwhelmed, stressed, or generally tired.

Speaker 1: A lot of what palliative care visits could have addressed would be those specific feelings. So it is possible that

We missed some patients who could have had a measurable benefit because they self selected out of the study.

Speaker 2: I'm curious to know if those patients eventually saw palliative care as part of their treatment.

Speaker 2: It sounds like potentially there would be something that comes down the pipeline that triggers it. Another thing I just wanted to point out is that they found no measurable harm in the intervention group for patients or surgeons. And this might seem obvious or not super relevant at first glance, but conversations in the palliative care space are often really difficult.

Speaker 2: They touch on sensitive topics. So it's important to see that these discussions didn't cause increased distress or actually worsen quality of life. This is just from my clinical experience, not from the data, but often people are really reluctant to talk about palliative options in addition to disease directed therapies.

Speaker 2: They think it might be viewed as them giving up or causing patients to lose hope. And there's this idea of, like, fighting. We always want to keep fighting. So you obviously have to meet patients where they're at. You can't push them to talk about things that they aren't ready to think about.

But it's really important to remember that palliative care can and should be delivered in parallel with life sustaining treatment.

Speaker 2: One doesn't cancel out the other. So, while there weren't measurable benefits to specialty palliative care co management in this study, surgeons should still feel empowered to integrate primary palliative care into their patient visits, eliciting their hopes, their goals, their concerns, building rapport, so that they can think about what treatment recommendations make the most sense for each patient.

Speaker 2: It's really hard, in my opinion, to find the right way to measure the value of a lot of these palliative care visit components, such as rapport building. providing space for the patient, or just offering support during a difficult time. Maybe I'm just on my soapbox, but Dr. O'Connell, what else would you add?

Speaker 3: At the risk of repeating myself, had the primary outcome been measured beyond three months, you know, perhaps at like a year when there would have been cancer recurrences, and when the palliative care team utilizes that built rapport, that is where the differences will be measured. Much, much easier said than

done in a randomized controlled

Speaker 1: trial.

Speaker 1: Thank you everyone for a really lively discussion about these two seminal palliative care randomized controlled trials in the surgical oncology patient population. While both of these were technically negative studies, in that neither of the studies detected a statistically significant difference in primary or secondary outcomes as related to health related quality of life scores, there are still many interesting insights to be gained from these trials and more room for further study.

Speaker 1: We would be particularly interested to see more research centering minoritized and marginalized patient populations and their engagement with palliative care during their cancer journeys. Of course, recognizing that there are limitations inherent to conducting these types of studies at tertiary referral centers.

Speaker 4: Well, we hope we shed some light on these RCTs for our listeners. And with that, until next time, dominate the

Speaker 3: day.

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