Abstract
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
Highlights
The impact of specialist palliative care intervention in patients undergoing surgery for cancer has not been studied extensively
Time frames for all outcomes will start on the day of surgery. This manuscript serves as the formal statistical analysis plan for the SCOPE randomized controlled trial
The statistical analysis plan was completed on 6 April 2021
Summary
Trial design The SCOPE Trial is a single-center, single-blind, prospective, randomized controlled trial. Model covariates All outcomes except 1-year all-cause mortality and time to initiation of adjuvant therapy within 90 days will be adjusted for using the following covariates:. If proportion of patients that were assessed at 90 days for the primary outcome between the two treatment groups is statistically significant at 5%, a sensitivity analysis will be conducted for the primary outcome, FACT-G TOI, and the secondary outcome, total FACT-G score, where the follow-up measure will be imputed by carrying the last observation (i.e., baseline observation) forward. Software details R version 4.0.3 (or above) will be used for all analyses [22]
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