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

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ClinicalTrials.gov Identifier: NCT03611309
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Stanford University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 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 : February 2021
Estimated Study Completion Date : February 2021


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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611309


Contacts
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Contact: Rebecca Aslakson 6507216669 aslakson@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94304
Contact: Shivani Chandrashekaran    650-721-3229    shivanic@stanford.edu   
Principal Investigator: Rebecca Aslakson, MD         
United States, Maryland
Johns Hopkins Hostpital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Thomas Smith, MD       tsmit120@jhmi.edu   
United States, Massachusetts
Dana Farber/ Brigham Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Elizabeth Rickerson, MD       erickerson@bwh.harvard.edu   
United States, New Mexico
University of New Mexico Not yet recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Bridget Fahy, MD       bfahy@salud.unm.edu   
Sponsors and Collaborators
Stanford University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Rebecca A. Aslakson, MD, Ph.D Stanford University

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT03611309     History of Changes
Other Study ID Numbers: IRB-45805
GI0020 ( Other Identifier: OnCore )
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases