Journal Article

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

Schütze, Leon, Schirren Rebekka, Studier-Fischer, Alexander, Feißt Manuel, Lull, Christian, Kühn, Jana, Engster, Simon, Günther, Tobias, Frey, Pia, Herrle Florian, Schömer Cuenca Sebastian, Schwab Marius, Bork, Ulrich, Lang, Hauke, Tachezy, Michael, Sander Anja, Fichtel Pascal, Boortz, Bertram, Rädeker Lukas, Doerr-Harim Colette, Rasel Hannah, Preuß, Sophie, Beier, Julian Pascal, Fink, Christopher, Thäwel, Thomas, Kartal, Nergiz, Bigge, Richard, Schnitzbauer, Andreas A, von Ehrlich-Treuenstätt Viktor, Leuck, Alexander, Beck, Lydia, Reckmann, Lisa, Möhwald Clara, Strahin, Stojanovich, Piel Sharlaine Yun Lan, Scholz, Alexander, Seide Svenja, Tenckhoff Solveig, Von der Waydbrink Henriette, Findeisen, Lisa, Pohl, Laura, Zimmermann, Petra, Tu Thomas Jing Zhi, Kuner Charlotte, Friedrich Mirco, Kerem Carmel, Holzner Philipp, Al Halabi Karam, Seckler Anna-Maria, Apfelbeck Antonia, Kreifels, Paul, Neudecker Jens, Wagner, Florian, Buia Alexander, Jörke Linda, Gablenz Eva, Faqar-Uz-Zaman, Sara Fatima, Klein, Adele, Mihaljevic, André L, Mihaljevic André, Scheuerpflug Anne, Alhalabi, Obada T, Hinz Nico, Rahbari, Nuh, Terbis

2021

Overview

BackgroundThe 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.MethodsPatients 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.ResultsData 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.ConclusionThe 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.

• Publisher: Springer Nature B.V
• Subject: Adverse events / Appetite loss / Cancer / Cancer surgery / Cohort analysis / Gastric cancer / Oncology / Patients / Surgery / Terminology