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

• ClinicalTrials.gov Identifier: NCT03611309
• Recruitment Status: Active, not recruiting
• First Posted: August 2, 2018
• Last Update Posted: February 24, 2023
• Sponsor: Stanford University
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gastrointestinal Cancer	Other: Surgeon-palliative care team co management; Other: Surgeon team alone management	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 378 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Multi-Center Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (the PERIOP-PC Trial)
• Actual Study Start Date: September 25, 2018
• Estimated Primary Completion Date: April 2023
• Estimated Study Completion Date: October 2023

Arms and Interventions

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
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

Outcome Measures

Primary Outcome Measures :

1. Patient quality of life [ Time Frame: Up to 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. The outcome will be reported as the median value per group, with full range.

Secondary Outcome Measures :

1. Patient mood symptoms assessment [ Time Frame: Up to 12 weeks after surgery ]
   Patient symptoms will be measured by Patient-Reported Outcomes Measurement Information System (PROMIS-29) version 2.0. The PROMIS-29 is health-related quality of life survey which assesses each of the 7 PROMIS domains (pain, fatigue, depression, anxiety, sleep, physical function and sexual function) with 4 questions. The questions are ranked on a 5-point Likert Scale and 11 point rating scale for pain intensity. The outcome will be reported as the median value per group, with full range.
2. Patient palliative symptoms assessment [ Time Frame: Up to 12 weeks after surgery ]
   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. The outcome will be reported as the median value per group, with full range.
3. Patient spiritual assessment [ Time Frame: Up to 12 weeks after surgery ]
   Patient spiritual symptoms assessment will be assessed using Functional Assessment of Chronic Illness Therapy - Spiritual Well-being; 12 item Spiritual Well-being Scale (FACIT-Sp-12). It is a 12 item questionnaire. The questions are ranked on a 4-point Likert Scale. The outcome will be reported as the median value per group, with full range.
4. Patient prognostic awareness assessment [ Time Frame: Up to 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. The questions are ranked on a 5-point Likert Scale. The outcome will be reported as the median value per group, with full range.
5. Patient mortality [ Time Frame: Up to 6 months after surgery ]
   Number of surviving patients in both arms will be reported at end of 6 months.
6. Caregiver mood symptom assessment [ Time Frame: Up to 12 weeks after surgery ]
   Caregiver symptoms will be measured by Patient-Reported Outcomes Measurement Information System (PROMIS-29). The PROMIS-29 is health-related quality of life survey which assesses each of the 7 PROMIS domains (pain, fatigue, depression, anxiety, sleep, physical function and sexual function) with 4 questions. The questions are ranked on a 5-point Likert Scale and 11 point rating scale for pain intensity. The outcome will be reported as the median value per group, with full range.
7. Caregiver burden measurement [ Time Frame: Up to 12 weeks after surgery ]
   Caregiver burden symptoms will be measured by Zarit Caregiver Burden Scale (ZBI-12) which measures 12 items ( 0-4 points per item, total score of 0-48). The outcome will be reported as the median value per group, with full range.
8. Caregiver spiritual measure [ Time Frame: Up to 12 weeks after surgery ]
   Caregiver spiritual symptoms assessment will be assessed using Functional Assessment of Chronic Illness Therapy - Spiritual Well-being; 12 item Spiritual Well-being Scale (FACIT-Sp-12). It is a 12 item questionnaire. The questions are ranked on a 4-point Likert Scale. The outcome will be reported as the median value per group, with full range.
9. Caregiver prognostic awareness assessment [ Time Frame: Up to 12 weeks after surgery ]
   Caregiver prognostic awareness is determined based on the Cancer Care Outcomes Research & Surveillance Consortium (CANCORS) study prognostic awareness questions before and after surgery. The questions are ranked on a 5-point Likert Scale. The outcome will be reported as the median value per group, with full range.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, California

Stanford University

Stanford, California, United States, 94304

United States, Maryland

Johns Hopkins Hostpital

Baltimore, Maryland, United States, 21287

United States, Massachusetts

Dana Farber/ Brigham

Boston, Massachusetts, United States, 02115

United States, New Mexico

University of New Mexico

Albuquerque, New Mexico, United States, 87131

United States, Ohio

Ohio State University Medical Center

Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Stanford University

Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Rebecca A. Aslakson, MD, Ph.D; Stanford University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT03611309
• Other Study ID Numbers: IRB-45805; GI0020 ( Other Identifier: OnCore )
• First Posted: August 2, 2018
• Last Update Posted: February 24, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stanford University:

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

Additional relevant MeSH terms:

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases