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Mihaljevic, André L.

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

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  • Medientyp: E-Artikel
  • Titel: 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
  • Beteiligte: Mihaljevic, André L.
  • Erschienen: Springer Science and Business Media LLC, 2021
  • Erschienen in: Annals of Surgical Oncology
  • Sprache: Englisch
  • DOI: 10.1245/s10434-021-09646-z
  • ISSN: 1068-9265; 1534-4681
  • Schlagwörter: Oncology ; Surgery
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>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-<jats:italic>Net</jats:italic> SIGMA study network.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>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’ (<jats:italic>p</jats:italic> = 0.021) and overall quality-of-life scores (<jats:italic>p</jats:italic> &lt; 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.</jats:p> </jats:sec><jats:sec> <jats:title>Conclusion</jats:title> <jats:p>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.</jats:p> </jats:sec>