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Randomized Controlled Trial
. 2023 May 1;6(5):e2314660.
doi: 10.1001/jamanetworkopen.2023.14660.

Effect of Perioperative Palliative Care on Health-Related Quality of Life Among Patients Undergoing Surgery for Cancer: A Randomized Clinical Trial

Rebecca A Aslakson  1 , Elizabeth Rickerson  2   3 , Bridget Fahy  4 , Brittany Waterman  5 , Rachel Siden  6 , Kathryn Colborn  7   8 , Shelby Smith  8 , Mae Verano  6 , Isaac Lira  9 , Caroline Hollahan  2 , Amn Siddiqi  10 , Kemba Johnson  11 , Shivani Chandrashekaran  12 , Elizabeth Harris  13   14 , Richard Nudotor  10 , Joshua Baker  9 , Shireen N Heidari  15 , George Poultsides  16 , Alison M Conca-Cheng  17 , Allyson Cook Chapman  18 , Anna Sophia Lessios  6 , Laura M Holdsworth  6 , Jillian Gustin  5 , Aslam Ejaz  19 , Timothy Pawlik  19 , Judi Miller  20 , Arden M Morris  16 , James A Tulsky  2   21 , Karl Lorenz  6   22 , Jennifer S Temel  23 , Thomas J Smith  24 , Fabian Johnston  10
Affiliations
Randomized Controlled Trial

Effect of Perioperative Palliative Care on Health-Related Quality of Life Among Patients Undergoing Surgery for Cancer: A Randomized Clinical Trial

Rebecca A Aslakson et al. JAMA Netw Open. .

Abstract

Importance: Involvement of palliative care specialists in the care of medical oncology patients has been repeatedly observed to improve patient-reported outcomes, but there is no analogous research in surgical oncology populations.

Objective: To determine whether surgeon-palliative care team comanagement, compared with surgeon team alone management, improves patient-reported perioperative outcomes among patients pursuing curative-intent surgery for high morbidity and mortality upper gastrointestinal (GI) cancers.

Design, setting, and participants: From October 20, 2018, to March 31, 2022, a patient-randomized clinical trial was conducted with patients and clinicians nonblinded but the analysis team blinded to allocation. The trial was conducted in 5 geographically diverse academic medical centers in the US. Individuals pursuing curative-intent surgery for an upper GI cancer who had received no previous specialist palliative care were eligible. Surgeons were encouraged to offer participation to all eligible patients.

Intervention: Surgeon-palliative care comanagement patients met with palliative care either in person or via telephone before surgery, 1 week after surgery, and 1, 2, and 3 months after surgery. For patients in the surgeon-alone group, surgeons were encouraged to follow National Comprehensive Cancer Network-recommended triggers for palliative care consultation.

Main outcomes and measures: The primary outcome of the trial was patient-reported health-related quality of life at 3 months following the operation. Secondary outcomes were patient-reported mental and physical distress. Intention-to-treat analysis was performed.

Results: In total, 359 patients (175 [48.7%] men; mean [SD] age, 64.6 [10.7] years) were randomized to surgeon-alone (n = 177) or surgeon-palliative care comanagement (n = 182), with most patients (206 [57.4%]) undergoing pancreatic cancer surgery. No adverse events were associated with the intervention, and 11% of patients in the surgeon-alone and 90% in the surgeon-palliative care comanagement groups received palliative care consultation. There was no significant difference between study arms in outcomes at 3 months following the operation in patient-reported health-related quality of life (mean [SD], 138.54 [28.28] vs 136.90 [28.96]; P = .62), mental health (mean [SD], -0.07 [0.87] vs -0.07 [0.84]; P = .98), or overall number of deaths (6 [3.7%] vs 7 [4.1%]; P > .99).

Conclusions and relevance: To date, this is the first multisite randomized clinical trial to evaluate perioperative palliative care and the earliest integration of palliative care into cancer care. Unlike in medical oncology practice, the data from this trial do not suggest palliative care-associated improvements in patient-reported outcomes among patients pursuing curative-intent surgeries for upper GI cancers.

Trial registration: ClinicalTrials.gov Identifier: NCT03611309.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Aslakson reported receiving grants from the Patient-Centered Outcomes Research Institute (PCORI) during the conduct of the study. Dr Fahy reported holding stock in Repligen Corp, Teladoc Health Inc, Guardant Health Inc, Bristol-Myers Squibb Co, Moderna Inc, Seagen Inc, and Editas Medicine Inc outside the submitted work. Dr Siden reported receiving grants from the PCORI during the conduct of the study. Dr Colborn reported receiving grants from a Stanford University subcontract and grants from the National Institutes of Health (NIH) National Institute of Nursing Research (NINR) during the conduct of the study; grants from the NIH NINR and grants from the Agency for Healthcare Research and Quality outside the submitted work. Mr Lira reported receiving grants from the PCORI during the conduct of the study. Ms Harris reported receiving grants from the PCORI during the conduct of the study. Dr Heidari reported grants from PCORI during the study. Dr Holdsworth reported receiving grants from the PCORI during the conduct of the study. Dr Tulsky reported receiving grants from the PCORI during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Patient Flowchart
Figure 2.
Figure 2.. Comparisons of Patient-Reported Outcomes Across Time and Treatment Group
Boxes indicate the IQR, black lines within the boxes indicate the medians, lines indicate quartile 1 − 1.5 × IQR (lower) and quartile 3 + 1.5 × IQR (upper). Dots represent potential outliers. FACIT indicates Functional Assessment of Chronic Illness Therapy; FACIT-Pal, FACIT–Palliative Care; FACT-G, Functional Assessment of Cancer Therapy–General; PROMIS, Patient-Reported Outcomes Measurement Information System; PROPr, PROMIS-Preference.
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