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

Gastrointestinal Cancer Clinical Trial

— PERIOP-PC  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611309
• Other study ID #: IRB-45805
• Secondary ID: GI0020
• Status: Completed
• Phase: N/A
• Start date: September 25, 2018
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Other:
• Surgeon-palliative care team co management
Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team
• Surgeon team alone management
The surgeon and surgical team will manage

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Johns Hopkins Hostpital	Baltimore	Maryland
United States	Dana Farber/ Brigham	Boston	Massachusetts
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient quality of life	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.	Up to 12 weeks after surgery
Secondary	Patient mood symptoms assessment	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.	Up to 12 weeks after surgery
Secondary	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. The outcome will be reported as the median value per group, with full range.	Up to 12 weeks after surgery
Secondary	Patient spiritual assessment	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.	Up to 12 weeks after surgery
Secondary	Patient prognostic awareness assessment	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.	Up to 12 weeks after surgery
Secondary	Patient mortality	Number of surviving patients in both arms will be reported at end of 6 months.	Up to 6 months after surgery
Secondary	Caregiver mood symptom assessment	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.	Up to 12 weeks after surgery
Secondary	Caregiver burden measurement	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.	Up to 12 weeks after surgery
Secondary	Caregiver spiritual measure	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.	Up to 12 weeks after surgery
Secondary	Caregiver prognostic awareness assessment	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.	Up to 12 weeks after surgery