A Multicenter, Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (PERIOP-PC).
Despite positive outcomes associated with specialist palliative care (PC) in diverse medical populations, little research has investigated specialist PC in surgical ones. Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortality persist, particularly for patients with upper gastrointestinal (GI) cancers.  Our objective is to complete a multicenter, randomized controlled trial comparing surgeon-PC co-management with surgeon-alone management among patients pursuing curative-intent surgery for upper GI cancers. We hypothesize that perioperative PC will improve patient postsurgical quality of life. This study and design are based on >8 years of engagement and research with patients, family members, and clinicians surrounding major cancer surgery and advance care planning/PC for surgical patients.  Randomized controlled superiority trial with two study arms (surgeon-PC team co-management and surgeon-alone management) and five data collection points over six months. The principal investigator and analysts are blinded to randomization.  Four, geographically diverse, academic tertiary care hospitals. Data collection began December 20, 2018 and continues to December 2020.  Patients recruited from surgical oncology clinics who are undergoing curative-intent surgery for an upper GI cancer.  In the intervention arm, patients receive care from both their surgical team and a specialist PC team; the PC is provided before surgery, immediately after surgery, and at least monthly until three months postsurgery. Patients randomized to the usual care arm receive care from only the surgical team.  Primary outcome: patient quality of life. Secondary outcomes: patient: symptom experience, spiritual distress, prognostic awareness, health care utilization, and mortality. Caregiver: quality of life, caregiver burden, spiritual distress, and prognostic awareness. Intent-to-treat analysis will be used.  This study has been approved by the institutional review boards of all study sites and is registered on clinicaltrials.gov (NCT03611309, First received: August 2, 2018).
['Aslakson|Rebecca A|RA|', 'Chandrashekaran|Shivani V|SV|', 'Rickerson|Elizabeth|E|', 'Fahy|Bridget N|BN|', 'Johnston|Fabian M|FM|', 'Miller|Judith A|JA|', 'Conca-Cheng|Alison|A|', 'Wang|Suwei|S|', 'Morris|Arden M|AM|', 'Lorenz|Karl|K|', 'Temel|Jennifer S|JS|', 'Smith|Thomas J|TJ|']
D000328:Adult D000368:Aged D000369:Aged, 80 and over D015142:Baltimore D001900:Boston D002140:California D013505:Digestive System Surgical Procedures D005190:Family D005260:Female D005770:Gastrointestinal Neoplasms D064946:Hospice and Palliative Care Nursing D006801:Humans D008297:Male D008875:Middle Aged D009516:New Mexico D017060:Patient Satisfaction D019990:Perioperative Care
perioperative palliative care palliative care for surgery patient-centered outcomes research