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

Trials

Laura M. Beskow¹  Aimee Hoskins²  E. Wesley Ely²  Rajiv Agarwal²  Rameela Chandrasekhar³  Ryan T. Jarrett³  Alaina Brown⁴  Myrick C. Shinall⁵  Christina Bailey⁶  Maria C. Duggan⁷  David F. Penson⁷  Alexander T. Hawkins⁸  Vyjeyanthi S. Periyakoil⁹ 

[1] Center for Biomedical Ethics and Society, Vanderbilt University Medical Center;Critical Illness, Brain Dysfunction, and Survivorship Center;Department of Biostatistics, Vanderbilt University School of Medicine;Division of GYN Oncology, Department of OB/GYN, Vanderbilt University Medical Center;Division of General Surgery, Department of Surgery, Vanderbilt University Medical Center;Division of Surgical Oncology, Department of Surgery, Vanderbilt University Medical Center;Geriatrics Research, Education, and Clinical Center, Veterans Affairs Tennessee Valley Health System;Section of Colon & Rectal Surgery, Division of General Surgery, Vanderbilt University Medical Center;Stanford University School of Medicine;

关键词: Palliative care;    Surgical oncology;    Cancer;    Randomized controlled trials;    Trial protocol;   

DOI  :  10.1186/s13063-019-3754-0

来源: DOAJ

【 摘 要 】

Abstract 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

【 授权许可】

Unknown