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

NCT ID: NCT03611309

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 379 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-25
• Study Completion Date: 2022-08-31

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.

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.

Conditions

Gastrointestinal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Surgeon-palliative care team co management

Intervention Type: OTHER

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

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

Group Type: OTHER

Surgeon team alone management

Intervention Type: OTHER

The surgeon and surgical team will manage

Interventions

Surgeon-palliative care team co management

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

Intervention Type: OTHER

Surgeon team alone management

The surgeon and surgical team will manage

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Karl Lorenz

Professor of Medicine (Primary Care and Population Health)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karl Lorenz, MD, MSHS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Johns Hopkins Hostpital

Baltimore, Maryland, United States

Dana Farber/ Brigham

Boston, Massachusetts, United States

University of New Mexico

Albuquerque, New Mexico, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38906425 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37256623 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31486730 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB-45805

Identifier Type: -

Identifier Source: org_study_id

NCI-2018-02183

Identifier Type: OTHER

Identifier Source: secondary_id