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A multi-center randomized controlled trial of perioperative palliative care surrounding cancer surgery for patients and their family members (The PERIOP PC Trial)
Investigator (PI): Aslakson, Rebecca A
Performing Organization (PO): (Current): Stanford University, School of Medicine, Department of Medicine, Division of Primary Care and Population Health / (650) 725-2747
(Past): Johns Hopkins Medicine, Department of Anesthesiology and Critical Care Medicine / (410) 955-8408
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2022
Record Source/Award ID: PCORI/IHS-1609-36518-IC ; PCORI/IHS-1609-36518
Funding: Total Award Amount: $2,147,407
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Although cancer surgery is safer than ever before, many cancer patients and their family members still suffer significant psychological and physical symptoms surrounding surgery and for weeks to months after surgery. Palliative care is patient and family centered care that symptomatically and psychosocially supports seriously ill patients and their families and optimizes quality of life, regardless of diagnosis, prognosis, or care goals. Multiple studies have shown the benefit of proactive palliative care for cancer patients and their families as they seek medical treatments for their cancer. However, there have been no studies exploring the potential benefit of proactive palliative care for cancer patients and their family members as they seek surgical treatments for their cancer. Our study goal is to explore whether proactive palliative care benefits patients and families undergoing major cancer surgery. Patients can be enrolled in this study if they are undergoing curative intent surgery for upper gastrointestinal cancers including pancreatic cancer, gastric cancer, liver cancer, gall bladder cancer, and esophageal cancer. The family members of these patients are also encouraged to enroll. Once enrolled in this study, patients are randomized to either: surgeon and surgical team management surrounding cancer surgery or surgeon and surgical team and palliative care team co-management surrounding cancer surgery. Within this trial, we will follow patients prior to cancer surgery and then for up to 12 weeks after surgery. We will measure the impact of proactive palliative care on outcomes including patient quality of life, physical, psychological, and spiritual distress, cancer knowledge, and mortality; and family member psychological and spiritual distress, cancer knowledge, and caregiver burden. We hypothesize that surgeon and palliative care team co-management will decrease patient and family member distress surrounding surgery and will improve the quality of life for patients undergoing major cancer surgery. This proposed study is based on over four years of intense engagement work including (a) in-depth interviews and engagement with perioperative patients, family members, the Johns Hopkins Hospital Patient and Family Advisory Council, and over 70 different patients, family members, surgeons, palliative care clinicians, and other stakeholders; (b) a cross-sectional survey of 359 patients and/or family members from the lay public concerning perioperative palliative care issues; (c) key informant interviews specifically about perioperative advance care planning and palliative care; and (d) development of a video based advance care planning aid for patients and family members who are preparing for major cancer surgery (the aid is currently under clinical trial). This proposal continues the partnership of PI (RA) and lead patient/family stakeholder (JM) who have co-published and closely worked together on this topic for over five years.
MeSH Terms:
  • Advance Care Planning
  • Baltimore
  • Caregivers
  • Cross-Sectional Studies
  • * Family Health
  • Gastrointestinal Neoplasms /psychology
  • /*surgery
  • Health Knowledge, Attitudes, Practice
  • Humans
  • Medical Oncology /*organization & administration
  • Multicenter Studies as Topic
  • Palliative Care /*organization & administration
  • Patient Education as Topic
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Spirituality
  • Stress, Psychological
Country: United States || United States
State: California || Maryland
Zip Code: 21287 / 94305
UI: 20181593
Project Status: Ongoing
Record History: ('2018: Project initial year changed to 2018 and final year extended to 2022.',) ('2019: PO changed from Johns Hopkins Medicine, Department of Anesthesiology and Critical Care Medicine to Stanford University, School of Medicine, Department of Medicine, Division of Primary Care and Population Health.',)