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are due March 25th. Hey

1:34

everyone, welcome back to another episode of Behind the

1:36

Knife with the Palliative Care team from University of

1:38

Washington. I'm Virginia

1:40

Wang, joined again by Lindsay Dickerson, Ali

1:43

Haruta, and Dr. Katie O'Connell. Today,

1:45

as part of our first journal review, we

1:47

have two exciting randomized controlled trials to discuss.

1:51

Dr. O'Connell, can you share some context for why we chose to

1:53

discuss these two trials? Of

1:55

course. There is a body

1:57

of work in the medical oncology

1:59

literature that has been done. included

2:01

multiple randomized control trials demonstrating benefits

2:04

of early palliative care for patients

2:06

with lung, GI, and

2:08

hematologic malignancies. Lindsay,

2:10

can you tell us about the kind of benefits

2:12

they have seen? Absolutely.

2:15

The list is long, and we know this both

2:17

from the data as well as our own clinical

2:19

experiences. Benefits include improved

2:21

patient quality of life, emotional well-being,

2:23

its symptom management, decreased

2:25

anxiety and helplessness, enhanced

2:28

goal-cucordic care, decreased

2:30

caregiver burden and distress, reduced

2:33

costs and decreased utilization of non-beneficial medical

2:35

care at the end of life, and

2:37

even prolonged survival in some populations. Similar

2:41

literature previously did not exist for

2:43

the surgical oncology patient population, which

2:46

makes these studies unique and important. The

2:48

study population in both these

2:50

studies are patients undergoing non-palliative

2:53

abdominal surgery for cancer. Yeah,

2:55

and I think a surgeon was more especially interested

2:57

in the sort of population, so looking

3:00

at palliative care in this space is

3:02

really interesting to us. The

3:04

first trial we'll be discussing was described

3:06

in the manuscript titled, Effects of Specialist

3:08

Palliative Care for Patients Undergoing Major Abdominal

3:11

Surgery for Cancer. This was

3:13

published in JAMS Survey this past May

3:15

by author Dr. Chanal Antin. The

3:18

primary objective of this single-center RCT

3:20

conducted at Vanderbilt was to determine

3:22

the effect of a specialist palliative

3:24

care intervention on patients undergoing abdominal

3:26

cancer operations for cure or durable

3:28

control of cancer. Lindsay,

3:31

tell us how the trial was designed. Sure,

3:33

Allie, and fair warning, I'm going to get

3:35

into a few details here. Between

3:39

2018 to 2021, 235 patients were

3:41

enrolled and randomized to either

3:43

the specialty palliative care intervention

3:45

or usual care group in

3:47

a one-to-run ratio. Both 217

3:50

of these 235 patients ultimately

3:53

included in the primary analysis. In

3:55

addition to usual surgical care, the

3:57

specialist palliative care intervention consisted of

4:00

primary elements. One, a

4:02

pre-op consultation with a palliative care physician

4:04

or NP in clinic or by phone.

4:07

Two, inpatient specialist palliative care

4:09

provider visits at least twice

4:11

weekly during the post-op hospital

4:13

stay. Three, follow-up clinic

4:15

visits or phone calls with the palliative

4:18

care specialist between hospital discharge and post-op

4:20

day 90. And finally,

4:22

an inpatient specialist palliative care visit

4:25

anytime the patient was readmitted to the hospital. Eligible

4:28

surgeries included your standard list of the

4:31

abdominal cancer operations including

4:33

gastrectomy, hepatitis me, pancreasectomy,

4:36

colectomy or proctectomy meeting specific

4:38

criteria given the relatively lower

4:40

associated and morbidity with these

4:42

surgeries, radical cystectomy pelvic

4:45

degeneration, and sider adaptive surgery

4:47

with or without. Oh

4:49

that was a lot. Virginia, can you briefly

4:52

tell us about the study population? Sure.

4:54

So the main takeaway is that this

4:57

trial focused on patients with what were

4:59

deemed to be resectable abdominal and pelvic

5:01

malignancies. There are a couple of additional

5:03

details to mention. So the most

5:06

common malignancies were bladder, colorectal, and

5:08

pancreatic cancer. About 60% of the patients

5:10

in the study had stage 3 or

5:12

4 disease and about 60% of the patients

5:14

received neo-adjuvant therapy.

5:17

One thing of note is that the vast

5:19

majority of all the study participants over 90%

5:22

self-identified as non-Hispanic white. Although

5:25

the study participants appear to have been distributed

5:27

along a range of incomes and to a

5:30

lesser extent a range of educational levels, minority

5:33

patients are severely underrepresented

5:35

in the study population. Thank

5:37

you for calling our attention to that Virginia. We'll keep

5:39

this in mind as we examine the outcomes of the

5:41

study and talk about it more in a bit. So

5:44

let's get into the outcomes. The

5:46

primary outcome was physical and functional

5:49

quality of life at post-epdainity which

5:51

was measured by what's called the

5:53

FACT-G or functional assessment of

5:56

cancer therapy general for G trial

5:58

alchem index. Gina, do you

6:00

remember the four quality of life domains

6:03

the FACT-G assesses? I do. They

6:05

are physical well-being, emotional well-being,

6:07

social or family well-being, and

6:10

maybe the easiest to forget, but one of

6:12

the most vitally important to patients, functional

6:15

well-being. That's right.

6:18

And the secondary outcomes that the study

6:20

was powered to assess included 90-day overall

6:22

quality of life for the FACT-G total

6:24

score versus the primary outcome which focused

6:26

on just the physical and functional quality

6:28

of life domains. Days

6:31

alive at home until post-op day 90, which

6:33

means not admitted to a hospital or seen

6:35

in the emergency department, and overall

6:37

survival at one year. Data

6:39

was analyzed using an intention-to-treat approach.

6:42

Great. Thanks for summarizing all that for me. So

6:45

let's talk about the results. Lindsay, what's

6:47

the one-liner decoy? Well,

6:50

in a few words, there was no

6:52

difference between groups in the primary or

6:54

secondary outcomes. So, specialist

6:57

palliative care in the perioperative

6:59

period for patients who underwent

7:01

non-palliative surgery for abdominal cancer

7:03

did not improve quality of life or

7:05

survival. But I think there are

7:07

more nuances to discuss, which is why we're all here.

7:10

Yeah, true. So, to

7:12

reiterate, there were no statistically significant

7:15

differences between the usual care and

7:17

the specialty palliative care intervention group

7:19

with regard to physical and functional quality of life,

7:22

overall quality of life. Days

7:24

alive at home until post-op day 90,

7:26

and overall survival at one year. In

7:29

the results, the authors also included

7:31

estimates of the Minimal Clinically Important

7:34

Differences, or MCID, from the literature. Dr.

7:36

Kahl, I wasn't super familiar with this term until

7:38

I read more about it. Can you share about

7:41

how I was applicable to this trial? Sure,

7:43

thanks for bringing me back in. The

7:46

MCID is a standard for determining

7:48

the effectiveness of an intervention and

7:50

measures essentially the smallest improvement that

7:53

would be worthwhile or meaningful to

7:55

a patient. This is

7:57

an important concept in this trial because not only

7:59

were. There no statistically significant

8:01

differences between groups. But.

8:03

There were also know clinically

8:06

meaningful differences. However,

8:08

The authors astutely pointed out that

8:10

the median baseline sacked G scores

8:12

for all patients in this study.

8:15

Before. The intervention was higher

8:17

than what is reported for

8:19

the gen U S population. So.

8:23

This. Specific population of surgical

8:25

patients. May. Have started off

8:27

with a lower palliative care

8:29

need compared to other oncology

8:31

or surgical patients. In

8:34

this context, it may not be surprising

8:36

that the Steady Dinner and cynically and

8:38

for differences and ninety days as measured

8:40

by any and see Id. We.

8:43

Need a speak? Well. I

8:45

think these results make sense and are not

8:47

necessarily contradictory to what we know about the

8:49

benefits of crowded of carry intervention. It

8:52

stands to reason that in order for

8:54

a patient to be offered a non

8:56

positive operation, they must have a height

8:58

of baseline of functional status. That.

9:01

The surgeon believes they can tolerate a

9:03

major abdominal operation with outlasting negative impact

9:05

on their quality of life. And functional

9:07

status. Assuming appropriate fusion selection

9:10

for surgery, this inherently biases or

9:12

study population toward patients with better

9:14

functional status and quality of life.

9:16

Compared to a beast, the average

9:18

oncology patient is not the general

9:20

population as the study suggested. Allium

9:22

Lindsay What other factors do you think? Contributed.

9:26

Yes, This might be standing us

9:28

somewhere on his arm and here, but

9:30

the patients in this study had less

9:32

advanced cancer. Overall, the Nas included in

9:34

other palliative care intervention studies. They

9:37

are also relatively young, with a median age

9:39

of sixty five. Soon. And measles

9:41

after under their functional sadness in. Both.

9:44

That are of the time. The surgery he

9:46

entered minded east coast.given a lower likelihood of

9:48

rapid cancer progression are visible, that line. I.

9:51

Agree Alley I would also add that A

9:53

Seat Hope plays a critically important role here,

9:56

and it's something as thought a lot about

9:58

in general because. In. The gone

10:00

college he like and palliative care. There's

10:03

this balance and also harmony between providing

10:05

whole thing and being realistic. Yeah.

10:08

If he were a lot more familiar with this

10:10

balance in the medical oncology population, for example, It's.

10:13

Important to be honest and realistic

10:15

when disclosing serious news like a poor

10:17

prognosis. Which. Can significantly decreased and

10:19

a mood and quality of life of patients.

10:22

But. Then you also want to provide a hope

10:24

that we have options to treat them as

10:26

a whole person, work and underhanded man. Even

10:29

though he can't share their cancer, we can

10:31

start helping. Their remaining time worked wilds of

10:33

them. That's. Absolutely right.

10:35

And I think the situation here is

10:37

different from what. You. Were just

10:39

talking about and medical oncology. These.

10:42

Patients in the surgical oncology world

10:44

are going into surgery with hope

10:46

for what they've been. Told

10:48

is absurd Ever disease control and surgery.

10:50

So once they've recovered from the operation

10:52

in the short term. Their. Physical

10:54

a social function on especially

10:56

emotional. Quality. Of Love and

10:58

Well Being is unsurprisingly similar to what

11:00

it was predominantly. Of personally

11:02

even seen this and patients who

11:04

returned to clinic after a successful

11:06

on logic surgery. I.

11:09

Think you're right. There is something about

11:11

that idea of sure that brings this

11:13

hopes. It's hard to quantify. It

11:15

also just wanted to know. That. They're expensive,

11:18

demonstrated in a medical oncology population

11:20

undergoing nonsurgical treatments a period of

11:22

time. Such. As stem cell transplant.

11:25

So. The opportunity for cure is not

11:27

the only factor that may have contributed to

11:29

the lack of effect seen in the third

11:32

oncology population. But. Certainly be

11:34

idea sure is an important. Source

11:36

of hope. So. Essentially, these patients

11:38

may not have had specific palliative your

11:40

needs of the time of intervention. The.

11:42

The doesn't mean that injuries in the topic

11:45

of palliative care or discussing prognosis for example

11:47

early in the course of cancer for these

11:49

patients is he not beneficial. It's

11:51

just a matter of how we measure any expected

11:53

benefit. When. You think Doctor Clough. Well.

11:57

i see that selection of

11:59

measurable primary outcome is really

12:01

key for detecting differences in

12:04

standard care versus palliative intervention

12:07

studies. If

12:09

the author selected quality of communication

12:11

with the medical team or

12:13

advanced directive completion or

12:16

extended the duration of the study to

12:18

capture recurrence of disease, which usually

12:20

doesn't occur within the study period of

12:23

90 days post-op, there

12:25

may have been a detectable difference. One

12:28

last thing before we move on from this study,

12:30

I think it's important to circle back about the

12:33

demographic factors that we mentioned at the beginning of

12:35

our discussion. As the authors of this

12:37

paper are very well aware, 90 to

12:39

95% of the patients recruited for

12:41

this study self-identified as non-Hispanic white.

12:43

So racial and ethnic minority populations

12:46

are vastly underrepresented here. The

12:48

authors also noted that patients with higher education

12:50

and the ability to travel for care, given

12:53

that this study was conducted at a

12:55

tertiary referral center, were overrepresented in the

12:57

study population as well. Particularly

12:59

since minoritized patients consistently have

13:01

worse outcomes compared with non-Hispanic

13:03

white patients in so

13:05

many different areas of health care,

13:07

including oncology, more outreach is warranted

13:10

to engage underrepresented minority patients and

13:12

address these disparities. This

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14:14

The athletes are doing out. There is

14:16

a study by Doctor Ingersoll call a

14:18

symbol included that show notes evaluating racial

14:21

and ethnic differences in prognosis communication. During.

14:23

In Peace and Palliative Care Concepts for patients

14:26

with cancer. The. Said he

14:28

found. unfortunately. That. Kindnesses communication

14:30

occurred less frequently for black

14:32

and Latino pieces. And

14:34

included see, we're optimistic he is. So.

14:38

I think that the load ever see of the studies

14:40

and port to know like you did. And

14:42

how pelletier interventions effect outcomes for

14:45

minority patience to cynically widespread

14:47

their say. A. Winner.

14:49

Is the results of the city

14:51

would be the same that other

14:53

centres providing censor care that sir

14:55

different population. Although so many specialists,

14:57

cancer centers, archers, your referral centers

14:59

that would be difficult. The.

15:02

Or what? While the majority of our

15:04

audience here lately practices and academic centers

15:06

were kill it of Care is. Integrated

15:09

into surgical care to some extent

15:11

it it is important to realize

15:13

that this is novel to most

15:15

not academic and rules surgery practices.

15:18

So. The results of palliative care studies

15:20

may not therefore newly be widely

15:22

applicable. Will. Keep his limitations

15:24

in mind as we move on to our

15:26

next randomized controlled trial. This. Rail

15:28

as described in the paper. Effective Perry

15:31

Operative Palliative Care on health related quality

15:33

of life. Among patients undergoing

15:35

surgery for cancer by doctor As Larson

15:37

and colleagues. Also. Published in May of

15:39

this past. Year and Gemma Network open. This.

15:42

Was a multicenter trial that recruited patients

15:44

at five sites. With. Upper Gi

15:46

I Cancer undergoing operations with cured of

15:48

Intent who had not previously received a

15:51

specialist. Praise care! The. Majority

15:53

of patients in this study had a

15:55

primary patriotic malignancy. The. studies patient

15:57

population also a self identified as

15:59

missouri non-Hispanic white, although minority

16:02

patients were somewhat better represented in this

16:04

multi-center study. A majority of

16:06

all of these patients, around 70% in

16:08

the control arm and around 60% in the

16:11

intervention arm, had a college degree

16:13

or higher. This study also recruited a slightly

16:15

more even distribution of men and women. Lindsay,

16:17

what else should we know about the study design? Always

16:20

making me go into the details of the

16:22

study design. So in

16:25

addition to usual surgical care, including

16:27

free op and post-op visits, patients

16:29

assigned to the intervention group met

16:31

either in person or via phone with

16:33

a member of an interprofessional palliative care

16:35

specialist team prior to surgery, one

16:38

week after surgery, and one, two, and three

16:40

months after surgery, with additional visits

16:42

scheduled at the discretion of the patient

16:44

surgical team or palliative care team. These

16:47

specialists were either hospice

16:49

and palliative medicine-boarded MDs,

16:52

ARNPs, social workers,

16:54

pharmacists, or chaplains trained in

16:56

palliative care with additional specific

16:59

training about GM emergencies. The

17:01

visits most often involved rapport building,

17:03

symptom management, illness education, and coping

17:06

with serious illness. Virginia,

17:08

what was a key difference that you noticed

17:10

in the usual care group for this study?

17:13

Well, this study was designed so that patients

17:15

in the usual care group could

17:17

actually receive a palliative care consultation if

17:19

the surgical team requested it, and

17:22

the surgical teams were encouraged to

17:24

follow NCCN recommended triggers to

17:27

involve specialty palliative care consultation. All

17:30

right, so what about the study outcomes? So

17:33

the study utilized several scales to assess

17:35

their primary outcomes. They're listed

17:37

in more detail as shown out, so I'm not

17:39

going to go into every single one, but basically

17:41

they looked at health-related physical and emotional quality of

17:43

life and mood symptoms. They then

17:45

calculated a summary score looking at several

17:48

different domains. Lindsay, can you tell us what

17:50

those are? Yeah, it might

17:52

be hard to remember all these, but luckily I have them

17:54

written here. Cognition, depression,

17:56

fatigue, pains, physical,

17:59

sleep, and social. That's

18:01

right. So the primary study

18:03

outcome was difference in patient-reported health-related

18:06

quality of light at three months

18:08

after surgery. Exploratory subgroup

18:10

analyses were planned as related to

18:12

race, ethnicity, and study sites. And

18:15

now the moment we've been waiting for, Virginia has taken

18:17

away with the result. Well, as in

18:20

the prior study, no statistically

18:22

significant differences were identified between the

18:24

control and intervention groups in any

18:26

of the health-related quality of light metrics. There

18:29

were also no significant differences in mortality

18:31

between the two groups. It

18:34

is interesting to see that 20 of the 177 patients randomized to the

18:38

control arm were actually referred for

18:40

palliative care consultations during the first three

18:42

months post-op, and five of the

18:44

patients were referred for hospice care. Notably,

18:47

one center accounted for the vast

18:49

majority of these crossover referrals, and

18:51

that is the same center that had the highest enrollment

18:54

in the study. This demonstrates some

18:56

variable practice of routine integration of

18:58

palliative care into surgical treatment nationwide.

19:01

Lindsey, do you want to talk a little bit about what

19:03

your takeaways were from this? Sure. I do

19:05

think that's a keen point in the difference in this

19:08

control population, that the

19:10

surgeons have the opportunity to refer patients

19:13

for palliative care treatment, and that 20

19:15

of the patients randomized to the control

19:17

group were referred. So

19:19

overall, like the first trial we

19:21

discussed, this trial also focused on

19:23

patients undergoing operations with care to

19:25

attend. The authors of this

19:27

study also noted that as

19:30

we have more nuanced discussions about the

19:32

best timing for palliative care interventions for

19:34

surgical oncology patients, the particular juncture

19:37

described in both of these trials

19:39

may be too early in the

19:41

patient's cancer journey to measure the

19:43

benefit of specialty or specialist palliative

19:45

care engagement. And this is like what

19:47

you touched on earlier, Dr. O'Connell. I'm

19:50

curious to hear what additional thoughts you might have.

19:53

Overall, it seems that it may

19:55

be more difficult to demonstrate a

19:57

measurable impact of specialty palliative

19:59

care. engagement at this time point

20:02

for patients with higher baseline quality

20:04

of life and milder

20:06

cancer-related symptoms, even

20:08

if they have a serious diagnosis

20:11

like an upper GI malignancy requiring

20:13

major abdominal surgery. I

20:15

also noticed that 119 eligible patients

20:17

actually declined to participate in this

20:19

study, and the most common reasons

20:22

they gave for declining to participate

20:24

included being too overwhelmed,

20:26

stressed, or generally tired. A

20:28

lot of what palliative care visits could have

20:30

addressed would be those specific feelings,

20:33

so it is possible that we

20:35

missed some patients who could have had

20:37

a measurable benefit because they self-selected out

20:39

of the study. I'm curious

20:41

to know if those patients have actually stopped palliative

20:43

care as part of their treatment. It sounds like

20:45

potentially there would be something that comes down the

20:48

pipeline that triggers it. Another

20:50

thing I just wanted to point out is that

20:52

they found no measurable harm in the intervention group

20:54

for patients or surgeons, and this

20:56

might seem obvious or not super relevant at

20:58

first glance, but conversations in the palliative care

21:00

space are often really difficult. They

21:03

touch on sensitive topics, so it's

21:05

important to see that these discussions didn't

21:07

cause increased distress or actually worsened quality

21:09

of life. This is

21:11

just from my clinical experience, not from

21:13

the data, but often people are really

21:15

reluctant to talk about palliative options in

21:17

addition to disease-directed therapies. They

21:20

think it might be viewed as them giving up or

21:22

causing patients to lose hope. And

21:24

there's this idea of, like, fighting. We always want

21:26

to keep fighting. So you obviously

21:29

have to meet patients where they're at. You can't

21:31

push them to talk about things that they aren't

21:33

ready to think about. But it's really

21:35

important to remember that palliative care can

21:37

and should be delivered in parallel with

21:39

life-sustaining treatment. One doesn't cancel out

21:41

the other. So while there

21:43

weren't measurable benefits to specialty palliative care

21:46

co-management in this study, surgeons

21:48

should still feel empowered to integrate primary palliative

21:50

care into the patient visit. Allocating

21:52

their hopes, their goals, their concerns, building

21:54

rapport so that they can think about

21:56

what treatment recommendations make the most sense

21:59

for each patient. It's really

22:01

hard in my opinion to find the right

22:03

way to measure the value of a lot

22:05

of these palliative care visit components such as

22:08

rapport building, providing space for the patient, or

22:10

just offering support during difficult times. Maybe

22:13

I'm just in my soapbox, but Dr. O'Connell, what else

22:15

would you add? At the

22:17

risk of repeating myself, had the primary

22:19

outcome been measured beyond three months, you

22:22

know, perhaps at like a year when there

22:24

would have been cancer recurrences and when the

22:26

palliative care team utilizes that

22:28

built rapport, that is

22:30

where the differences will be measured. Much,

22:33

much easier said than done in a

22:35

randomized controlled trial. Thank

22:38

you everyone for a really lively discussion

22:40

about these two seminal palliative care randomized

22:42

controlled trials in the surgical-alcoholic patient population.

22:45

While both of these were technically negative studies,

22:48

in that neither of the studies detected

22:50

a statistically significant difference in primary or

22:53

secondary outcomes as related to health-related quality

22:55

of life scores, there are still

22:57

many interesting insights to be gained from these trials

23:00

and more room for further study. We

23:02

would be particularly interested to see more

23:04

research centering minoritized and marginalized patient populations

23:06

and their engagement with palliative care during

23:09

their cancer journeys, of course recognizing

23:11

that there are limitations inherent to

23:13

conducting these types of studies at tertiary

23:16

referral centers. So,

23:18

we hope we shed some light

23:20

on these RCTs for our listeners

23:22

and with that, until next

23:24

time, dominate the day. Be

23:27

sure to check out our website at www.behindtheknife.org

23:29

for more great content. You can also follow

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us on Twitter at Behind the Knife and

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Instagram at Behind the Knife podcast. If you

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like what you hear, please take a minute

23:38

to leave us a review. Content

23:40

produced by Behind the Knife is intended for

23:42

health professionals and is for educational purposes only.

23:44

We do not diagnose, treat, or offer patient-specific

23:47

advice. Thank you for listening. Until

23:50

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