Perioperative Palliative Care Surrounding Cancer Surgery for Patients & Their Family Members

NCT03611309 | Completed Results

• 2 other identifiers: IRB-45805NCI-2018-02183
• Study Type: interventional
• Target: 379
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Gastrointestinal Cancer

Keywords

Pancreatic Cancer; Hepatocellular Cancer; Esophageal Cancer; Gastric Cancer; Cholangio carcinomas

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Patient Mood Symptoms Assessment 12 Weeks After Surgery

  Up to 12 weeks after surgery

• Patient Palliative Symptoms Assessment

  Up to 12 weeks after surgery

• Patient Spiritual Assessment 12 Weeks After Surgery

  Up to 12 weeks after surgery

• Patient Prognostic Awareness Assessment Assessment 12 Weeks After Surgery

  Up to 12 weeks after surgery

• Patient Mortality up to 6 Months

  Up to 6 months after surgery

Study Arms (2)

Surgeon-palliative care team co-management

EXPERIMENTAL

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 alone management

OTHER

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

Interventions

Surgeon team alone management OTHER

The surgeon and surgical team will manage

Surgeon alone management

Surgeon-palliative care team co management OTHER

Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team

Surgeon-palliative care team co-management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (5)

Stanford University

Stanford, California, 94304, United States

Location

Johns Hopkins Hostpital

Baltimore, Maryland, 21287, United States

Location

Dana Farber/ Brigham

Boston, Massachusetts, 02115, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (3)

• 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.

  PMID: 38906425 DERIVED

• 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.

  PMID: 37256623 DERIVED

• 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.

  PMID: 31486730 DERIVED

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Diseases

Limitations and Caveats

Over half of the study occurred during the COVID-19 pandemic, with potential pandemic-related impacts. A majority of participants were White and highly educated, and they received care from urban and suburban tertiary or quaternary medical centers; study results may be less generalizable for non-White, less educated, or rural populations.

Results Point of Contact

• Title: Karl Lorenz, MD MSHS
• Organization: Stanford University

kalorenz@stanford.edu

650-498-9822

Study Officials

• Karl Lorenz, MD, MSHS

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Primary Care and Population Health)

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 2, 2018
• Study Start: September 25, 2018
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: January 8, 2026
• Results First Posted: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)