Multicenter Prospective Cohort Study of the Patient-Reported Outcome Measures PRO-CTCAE and CAT EORTC QLQ-C30 in Major Abdominal Cancer Surgery (PATRONUS): A Student-Initiated German Medical Audit (SIGMA) Study.

Autor: CHIR-Net SIGMA Study Group*, Mihaljevic, André, Fink, Christopher, Frey, Pia, Friedrich, Mirco, Leuck, Alexander, Rädeker, Lukas, Schwab, Marius, Doerr-Harim, Colette, Tenckhoff, Solveig, Feißt, Manuel, Faqar-Uz-Zaman, Sara Fatima, Brindl, Niall, Tu, Thomas Jing Zhi, Studier-Fischer, Alexander, Kuner, Charlotte, Gsenger, Julia, Möhwald, Clara, Prem, Markus, Von der Waydbrink, Henriette
Zdroj: Annals of Surgical Oncology: An Oncology Journal for Surgeons; Jun2021, Vol. 28 Issue 6, p3075-3089, 15p
Abstrakt: Background: The patient-reported outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the computerized adaptive testing (CAT) version of the EORTC quality-of-life questionnaire QLQ-C30 have been proposed as new PRO measures in oncology; however, their implementation in patients undergoing cancer surgery has not yet been evaluated. Methods: Patients undergoing elective abdominal cancer surgery were enrolled in a prospective multicenter study, and postoperative complications were recorded according to the Dindo–Clavien classification. Patients reported PRO data using the CAT EORTC QLQ-C30 and the PRO-CTCAE to measure 12 core cancer symptoms. Patients were followed-up for 6 months postoperatively. The study was carried out by medical students of the CHIR-Net SIGMA study network. Results: Data of 303 patients were obtained and analyzed across 15 sites. PRO-CTCAE symptoms 'poor appetite', 'fatigue', 'exhaustion' and 'sleeping problems' increased after surgery and climaxed 10–30 days postoperatively. At 3–6 months postoperatively, no PRO-CTCAE symptom differed significantly to baseline. Patients reported higher 'social functioning' (p = 0.021) and overall quality-of-life scores (p < 0.05) 6 months after cancer surgery compared with the baseline level. There was a lack of correlation between postoperative complications or death and any of the PRO items evaluated. Feasibility endpoints for student-led research were met. Conclusion: The two novel PRO questionnaires were successfully applied in surgical oncology. Postoperative complications do not affect health-reported quality-of-life or common cancer symptoms following major cancer surgery. The feasibility of student-led multicenter clinical research was demonstrated, but might be enhanced by improved student training. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index