Clinical trial NCT03611309: Perioperative Palliative Care Surrounding Cancer Surgery for Patients & Their Family Members
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Cancer
Keywords: Pancreatic Cancer
Hepatocellular Cancer
Esophageal Cancer
Gastric Cancer
Cholangio carcinomas
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2018-08-02
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Patient quality of life
timeFrame: Up to 12 weeks after surgery
Secondary outcomes:
measure: Patient mood symptoms assessment
timeFrame: Up to 12 weeks after surgery
measure: Patient palliative symptoms assessment
timeFrame: Up to 12 weeks after surgery
measure: Patient spiritual assessment
timeFrame: Up to 12 weeks after surgery
measure: Patient prognostic awareness assessment
timeFrame: Up to 12 weeks after surgery
measure: Patient mortality
timeFrame: Up to 6 months after surgery
measure: Caregiver mood symptom assessment
timeFrame: Up to 12 weeks after surgery
measure: Caregiver burden measurement
timeFrame: Up to 12 weeks after surgery
measure: Caregiver spiritual measure
timeFrame: Up to 12 weeks after surgery
measure: Caregiver prognostic awareness assessment
timeFrame: Up to 12 weeks after surgery
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Baltimore
country: United States
facility: Johns Hopkins Hostpital
state: Maryland
city: Boston
country: United States
facility: Dana Farber/ Brigham
state: Massachusetts
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Stanford University
name: Rebecca A. Aslakson, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.