Perioperative Palliative Care Surrounding Cancer Surgery for Patients & Their Family Members (PERIOP-PC)

A Multi-Center Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (the PERIOP-PC Trial)

The study goal is to compare surgeon-palliative care team co-management, versus surgeon alone management, of patients and family members preparing for major upper gastrointestinal cancer surgery. The study also aims to explore, using qualitative methods, the impact of surgeon-palliative care team co-management versus surgeon alone management on the perioperative care experience for patients, family members, surgeons, and palliative care clinicians.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Cancer
• Intervention / Treatment: Other: Surgeon-palliative care team co management; Other: Surgeon team alone management

Detailed Description

The components of surgeon palliative care team co management practices will include Time, Education, Assessments, and Multi disciplinary (TEAM) element.

1. Time; At least 60 minutes/month (per patient and caregiver preference) devoted to palliative care treatments for the patient and family
2. Education - Patients and family members, per their desires and wishes, are counseled and educated about their disease, including self-management of symptoms, prognosis, and treatment options
3. Assessment - Formal assessment of symptoms including pain, dyspnea, constipation/diarrhea, anxiety/depression, fatigue, and nausea. Edmonton symptom score33 will be used as a formal assessment.
4. Multi-Disciplinary - Management must be multi disciplinary with access to a multi-disciplinary palliative care team composed of nurse, physician, social worker, pharmacist, and/or chaplain team members.

• Study Type: Interventional
• Enrollment (Actual): 379
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Stanford University
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hostpital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber/ Brigham
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age and must be able to give informed consent.
• Diagnosed with pancreatic cancer or hepatocellular cancer or esophageal cancer or gastric cancer and/or cholangio carcinomas
• Non emergent, upper gastrointestinal cancer related surgery with a goal of primary resection of the tumor- optimal surgical goal is cure, not merely disease palliation.
• One companion per patient will be allowed to participate. In addition, to being identified by the patient at being a key caregiver throughout the surgery period, these companions must be able to give informed consent and at least 18 years of age.

Exclusion Criteria:

• No previous involvement of palliative care providers in their care course

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgeon-palliative care team co-management; In the Surgeon-palliative care team co-management arm, all patients receive the surgical care of surgeon alone management, which includes surgeon and the surgical team. In addition to this surgeon alone care, palliative care will also be provided by a specialist team. For patients in this arm, patients and/or family members will be seen by the palliative care team: (1) in an outpatient setting prior to surgery, (2) in the hospital within 72 hours of their initial surgery and as needed afterwards, and (3) via phone on in-clinic (per patient preference) on an at least monthly basis and/or as needed for 12 weeks following surgery.	Other: Surgeon-palliative care team co management; Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team
Other: Surgeon alone management; The surgeon and surgical team will manage symptoms, psychosocial support, and prognostic related communication. The surgeon and surgical team care for the patient and their family both prior to and following surgery. The surgeon team is given guidelines published by the National Cancer Coalition Network as to when palliative care specialist consultation is recommended	Other: Surgeon team alone management; The surgeon and surgical team will manage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Quality of Life Patient Quality of Life 12 Weeks After Surgery	Patient quality of life will be measured by the Functional Assessment of Chronic Illness Therapy Palliative care subscale (FACIT-PAL). FACIT-PAL is a compilation of general questions divided into four primary QOL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. FACIT-PAL has 46 item self report measure. The range is from 0-184 for the FACIT-PAL. A higher score is a better outcome.	Up to 12 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Mood Symptoms Assessment 12 Weeks After Surgery	Patient symptoms were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29) version 2.1. PROMIS-29 survey questions were each rated on a 5-point Likert scale (range: 1 to 5, higher scores represent a better outcome). Item responses were converted to PROMIS T-scores per the PROMIS scoring manual (population mean = 50, SD = 10). T-scores were then converted to standardized z-scores using the formula (T-score - 50) / 10. Composite physical and mental health z-scores were calculated using weighted domain z-scores. Higher z-scores indicate better outcomes, and negative z-scores indicate scores below the population reference mean.	Up to 12 weeks after surgery
Patient Palliative Symptoms Assessment	Patient will be assessed for twelve symptoms (pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath, constipation, financial distress, and spiritual pain) using a modified Edmonton Symptom Assessment System (ESAS). Each symptom is rated from 0 to 10 on a numerical scale, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity.	Up to 12 weeks after surgery
Patient Spiritual Assessment 12 Weeks After Surgery	Patient spiritual symptoms assessment will be assessed using Functional Assessment of Chronic Illness Therapy - Spiritual Well-being (FACIT-Sp-12); 12 item Spiritual Well-being Scale. Score range: 0 to 48; higher scores correspond to better spiritual well-being.	Up to 12 weeks after surgery
Patient Prognostic Awareness Assessment Assessment 12 Weeks After Surgery	Patient prognostic awareness is determined based on the Cancer Care Outcomes Research & Surveillance Consortium (CANCORS) study prognostic awareness questions before and after surgery. To each question, the respondent replied Very likely, Somewhat likely, A little likely, Not at all likely, or Don't know.	Up to 12 weeks after surgery
Patient Mortality up to 6 Months	Number of surviving patients in both arms will be reported at end of 6 months.	Up to 6 months after surgery
Caregiver Mood Symptom Assessment at 12 Weeks After Surgery	Caregiver symptoms were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29) version 2.1. PROMIS-29 survey questions were each rated on a 5-point Likert scale (range: 1 to 5, higher scores represent a better outcome). Item responses were converted to PROMIS T-scores per the PROMIS scoring manual (population mean = 50, SD = 10). T-scores were then converted to standardized z-scores using the formula (T-score - 50) / 10. Composite physical and mental health z-scores were calculated using weighted domain z-scores. Higher z-scores indicate better outcomes, and negative z-scores indicate scores below the population reference mean.	Up to 12 weeks after surgery
Caregiver Burden Measurement 12 Weeks After Surgery	The Zarit Caregiver Burden Scale (ZBI-12) is a 12-item measure of caregiver burden caring for a patient with chronic illness, focusing on the emotional, physical, and social aspects of caregiving. The questions are ranked on a 5-point Likert scale. The total score is 0-48 a higher score indicates a worse outcome (more caregiver burden).	Up to 12 weeks after surgery
Caregiver Spiritual Measure at 12 Weeks	Caregiver spiritual symptoms assessment will be assessed using Functional Assessment of Chronic Illness Therapy - Spiritual Well-being (FACIT-Sp-12); 12 item Spiritual Well-being Scale (score range: 0 to 48; higher scores correspond to better spiritual well-being).	Up to 12 weeks after surgery
Caregiver Prognostic Awareness Assessment at 12 Weeks	Caregiver prognostic awareness was determined based on the Cancer Care Outcomes Research & Surveillance Consortium (CANCORS) study prognostic awareness questions before and after surgery. To each question, the respondent replied Very likely, Somewhat likely, A little likely, Not at all likely, or Don't know.	Up to 12 weeks after surgery

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Karl Lorenz, MD, MSHS, Stanford University

Publications and helpful links

General Publications

• Aslakson RA, Chandrashekaran SV, Rickerson E, Fahy BN, Johnston FM, Miller JA, Conca-Cheng A, Wang S, Morris AM, Lorenz K, Temel JS, Smith TJ. A Multicenter, Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (PERIOP-PC). J Palliat Med. 2019 Sep;22(S1):44-57. doi: 10.1089/jpm.2019.0130.
• Holdsworth LM, Siden R, Lessios AS, Verano M, Rickerson E, Fahy B, Johnston FM, Waterman B, Aslakson R. Patient Experiences of Specialty Palliative Care in the Perioperative Period for Cancer Surgery. J Pain Symptom Manage. 2024 Sep;68(3):292-298.e1. doi: 10.1016/j.jpainsymman.2024.06.008. Epub 2024 Jun 19.
• Aslakson RA, Rickerson E, Fahy B, Waterman B, Siden R, Colborn K, Smith S, Verano M, Lira I, Hollahan C, Siddiqi A, Johnson K, Chandrashekaran S, Harris E, Nudotor R, Baker J, Heidari SN, Poultsides G, Conca-Cheng AM, Cook Chapman A, Lessios AS, Holdsworth LM, Gustin J, Ejaz A, Pawlik T, Miller J, Morris AM, Tulsky JA, Lorenz K, Temel JS, Smith TJ, Johnston F. Effect of Perioperative Palliative Care on Health-Related Quality of Life Among Patients Undergoing Surgery for Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2314660. doi: 10.1001/jamanetworkopen.2023.14660.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2018
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Gastric Cancer; Pancreatic Cancer; Esophageal Cancer; Hepatocellular Cancer; Cholangio carcinomas
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Pancreatic Diseases; Liver Diseases; Esophageal Diseases; Stomach Neoplasms; Esophageal Neoplasms; Pancreatic Neoplasms; Gastrointestinal Neoplasms; Liver Neoplasms
• Other Study ID Numbers: IRB-45805; NCI-2018-02183 (Other Identifier: National Cancer Institute Clinical Trials Reporting Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No