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

Primary Purpose

Gastrointestinal Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgeon-palliative care team co management
Surgeon team alone management
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastrointestinal Cancer focused on measuring Pancreatic Cancer, Hepatocellular Cancer, Esophageal Cancer, Gastric Cancer, Cholangio carcinomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University
  • Johns Hopkins Hostpital
  • Dana Farber/ Brigham
  • University of New Mexico
  • Ohio State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Surgeon-palliative care team co-management

Surgeon alone management

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Patient mortality
Number of surviving patients in both arms will be reported at end of 6 months.
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.
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.
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.
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.

Full Information

First Posted
July 25, 2018
Last Updated
August 22, 2023
Sponsor
Stanford University
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03611309
Brief Title
Perioperative Palliative Care Surrounding Cancer Surgery for Patients & Their Family Members
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 25, 2018 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
The components of surgeon palliative care team co management practices will include Time, Education, Assessments, and Multi disciplinary (TEAM) element. Time; At least 60 minutes/month (per patient and caregiver preference) devoted to palliative care treatments for the patient and family 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 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer
Keywords
Pancreatic Cancer, Hepatocellular Cancer, Esophageal Cancer, Gastric Cancer, Cholangio carcinomas

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
378 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgeon-palliative care team co-management
Arm Type
Experimental
Arm Description
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.
Arm Title
Surgeon alone management
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Surgeon-palliative care team co management
Intervention Description
Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team
Intervention Type
Other
Intervention Name(s)
Surgeon team alone management
Intervention Description
The surgeon and surgical team will manage
Primary Outcome Measure Information:
Title
Patient quality of life
Description
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.
Time Frame
Up to 12 weeks after surgery
Secondary Outcome Measure Information:
Title
Patient mood symptoms assessment
Description
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.
Time Frame
Up to 12 weeks after surgery
Title
Patient palliative symptoms assessment
Description
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.
Time Frame
Up to 12 weeks after surgery
Title
Patient spiritual assessment
Description
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.
Time Frame
Up to 12 weeks after surgery
Title
Patient prognostic awareness assessment
Description
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.
Time Frame
Up to 12 weeks after surgery
Title
Patient mortality
Description
Number of surviving patients in both arms will be reported at end of 6 months.
Time Frame
Up to 6 months after surgery
Title
Caregiver mood symptom assessment
Description
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.
Time Frame
Up to 12 weeks after surgery
Title
Caregiver burden measurement
Description
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.
Time Frame
Up to 12 weeks after surgery
Title
Caregiver spiritual measure
Description
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.
Time Frame
Up to 12 weeks after surgery
Title
Caregiver prognostic awareness assessment
Description
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.
Time Frame
Up to 12 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca A. Aslakson, MD, Ph.D
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Johns Hopkins Hostpital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Dana Farber/ Brigham
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31486730
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.
Results Reference
derived

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

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