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

Background The 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 design The 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. Results The 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. Conclusion This 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 registration ClinicalTrials.gov NCT03436290. Registered on 16 February 2018

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

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

The Development of Comic on Sub-Theme “National Events” Concerning National Dependence Proclamation to Inculcate Discipline Character

The learning process germane to the national events sub-theme surrounding the proclamation of independence requires a media that is able to become a means of delivering abstract material to be concrete not just images available in textbooks, for which more innovative media is needed, namely learning media in comic form. This study aims to produce learning media in the form of comics that can foster the character of discipline, using the R & D model from Borg and Gall (2003) which consists of 7 stages. It aims to describe the process, produce products and disseminate products. The aspects of media quality studied are validity and effectiveness. The media developed is evaluated by material experts and media to determine its feasibility. The subjects of this study were all VA students of SDN Kebonsari 03 Jember, which included 35 students as subjects of the small-scope trial. 25 VA students from Public Elementary School Kebonsari 04 Jember were involved in a control class, and 26 VB students were involved in the experimental class. The data collection in this study was done through observation, interviews, questionnaires, tests, and validation. The results of data analysis showed that the media was proven valid with the validator percentage validating 80.3%. The percentage of student learning outcomes was 82.35%. The average results of student affective assessment for disciplinary characters are 95%. From these results, it can be concluded that comic media has fulfilled the quality aspects of the media and can be used as a medium of learning in schools. In the field trial, the results obtained for the control class average pretest score was 75.2 and the average posttest score was 82.5. The experimental class obtained an average score of 78.1 in pretest and 90.2 in the posttest score. Learning with comic media developed is proven effective to foster the character of discipline.