Statistical analysis plan for the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) trial: a randomized controlled trial of a specialist palliative care intervention for patients undergoing surgery for cancer

Trials

Ellis Morgan¹  Aimee Hoskins¹  E. Wesley Ely²  Myrick C. Shinall³  Rameela Raman⁴  Onur M. Orun⁴  Mohana Karlekar⁵  Sara F. Martin⁵ 

[1] Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, Nashville,, TN, USA;Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, Nashville,, TN, USA;Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville,, TN, USA;Geriatrics Research, Education, and Clinical Center, Veterans Affairs Tennessee Valley Health System, Nashville,, TN, USA;Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, Nashville,, TN, USA;Division of General Surgery, Department of Surgery, Vanderbilt University Medical Center, Nashville,, TN, USA;Section of Palliative Care, Department of Medicine, Vanderbilt University Medical Center, Nashville,, TN, USA;Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville,, TN, USA;Department of Biostatistics, Vanderbilt University Medical Center, 2525 West End, Suite 1100, 37203, Nashville, TN, USA;Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, Nashville,, TN, USA;Section of Palliative Care, Department of Medicine, Vanderbilt University Medical Center, Nashville,, TN, USA;

关键词: Palliative care;    Surgical oncology;    Cancer;    Randomized controlled trial;    Statistical analysis plan;   

DOI  :  10.1186/s13063-021-05256-y

来源: Springer

【 摘 要 】

BackgroundThe impact of specialist palliative care intervention in patients undergoing surgery for cancer has not been studied extensively. The SCOPE randomized controlled trial will investigate the effect of specialist palliative care intervention in cancer patients undergoing surgery for selected abdominal malignancies. The study protocol of the SCOPE Trial was published in December 2019.Methods and designThe SCOPE Trial is a single-center, single-blind, prospective, randomized controlled trial that will investigate specialist palliative care intervention for cancer patients undergoing surgery for selected abdominal malignancies. The study plans to enroll 236 patients that will be randomized to specialist palliative care (intervention arm) and usual care (control arm) in a 1:1 ratio.ResultsThe primary outcome of the study is the Functional Assessment of Cancer Therapy-General (FACT-G) Trial Outcome Index (TOI) at 90 days postoperatively. Secondary outcomes of the study include the total FACT-G score at 90 days postoperatively, days alive at home without an emergency room visit within 90 days of operation, and all-cause mortality at 1 year after operation. Time frames for all outcomes will start on the day of surgery.ConclusionThis manuscript serves as the formal statistical analysis plan (version 1.0) for the SCOPE randomized controlled trial. The statistical analysis plan was completed on 6 April 2021.Trial registrationClinicalTrials.gov NCT03436290. Registered on 16 February 2018

【 授权许可】

CC BY