Journal Article

A randomized trial of a specialist palliative care intervention for patients undergoing surgery for cancer: rationale and design of the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) Trial

Ely, E. Wesley, Periyakoil, Vyjeyanthi S., Penson, David F., Shinall, Myrick C., Duggan, Maria C., Brown, Alaina, Beskow, Laura M., Hawkins, Alexander T., Jarrett, Ryan T., Bailey, Christina, Chandrasekhar, Rameela, Hoskins, Aimee, Agarwal, Rajiv

2019

Overview

Background In medical oncology settings, early specialist palliative care interventions have demonstrated improvements in patient quality of life and survival compared with usual oncologic care. However, the effect of early specialist palliative care interventions in surgical oncology settings is not well studied. Methods The Surgery for Cancer with Option for Palliative Care Expert (SCOPE) Trial is a single-center, prospective, single-blind, randomized controlled trial of a specialist palliative care intervention for cancer patients undergoing non-palliative surgery. It will enroll 236 patients scheduled for major abdominal operations for malignancy, who will be randomized 1:1 at enrollment to receive usual care (control arm) or specialist palliative care consultation (intervention arm). Intervention arm patients will receive consultations from a palliative care specialist (physician or nurse practitioner) preoperatively and postoperatively. The primary outcome is physical and functional wellbeing at 90 days postoperatively. Secondary outcomes are quality of life at 90 days postoperatively, posttraumatic stress disorder symptoms at 180 days postoperatively, days alive at home without an emergency room visit in the first 90 postoperative days, and overall survival at 1 year postoperatively. Participants will be followed for 3 years after surgery for exploratory analyses of their ongoing quality of life, healthcare utilization, and mortality. Discussion SCOPE is an ongoing randomized controlled trial evaluating specialist palliative care interventions for cancer patients undergoing non-palliative oncologic surgery. Findings from the study will inform ways to identify and improve care of surgical patients who will likely benefit from specialist palliative care services. Trial registration ClinicalTrials.gov Identifier: NCT03436290 First Registered: 16 February 2018 Enrollment Began: 1 March 2018 Last Update: 20 December 2018

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Abdomen / Biomedicine / Cancer / Cancer patients / Cancer research / Cancer therapies / Caregivers / Chemotherapy / Colorectal surgery / Comparative analysis / Consent / Cystectomy - adverse effects / Cytoreduction Surgical Procedures - adverse effects / Design / Digestive System Surgical Procedures - adverse effects / Disease / Emergency medical services / Enrollments / Female / Health aspects / Health Sciences / Health Status / Hospital patients / Humans / Intervention / Male / Medical care quality / Medical records / Medical referrals / Medicine / Medicine & Public Health / Mental Health / Metastasis / Mortality / Neoplasms - diagnosis / Neoplasms - psychology / Neoplasms - surgery / Nurse practitioners / Nurses / Oncology / Palliative Care / Patients / Perioperative Care / Physicians / Post traumatic stress disorder / Prospective Studies / Quality of Life / Randomized controlled trials / Randomized Controlled Trials as Topic / Schedules / Single-Blind Method / Statistics for Life Sciences / Study Protocol / Surgical oncology / Tennessee / Time Factors / Treatment Outcome / Trial protocol