Abstract
BackgroundOne of the most important aspects of designing a clinical trial is selecting appropriate outcomes. Patient-reported outcomes (PROs) can provide a personal assessment of the burden and impact of a malignant disease and its treatment. PROs comprise a wide range of outcomes including basic clinical symptom scores and complex metrics such as health-related quality of life (HRQoL). There is limited data on how postoperative complications following cancer surgery affect symptoms and HRQoL. For this reason the primary aim of the PATRONUS study is to investigate how perioperative complications affect cancer-related symptoms and HRQoL in patients undergoing abdominal cancer surgery. The PATRONUS study is designed and will be initiated and conducted by medical students under the direct supervision of clinician scientists based on the concept of inquiry-based learning.MethodsPATRONUS is a non-interventional prospective multicentre cohort study. Patients undergoing elective oncological abdominal surgery will be recruited at regional centres of the clinical network of the German Surgical Society (CHIR-Net) and associated hospitals.A core set of 12 cancer associated symptoms will be assessed via the PRO version of the Common Terminology Criteria for Adverse Events. The cancer-specific HRQoL will be measured via the computerised adaptive testing version of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30. PROs will be measured eight times over a period of six months. The short-term clinical outcome measure is the rate of postoperative complications (grade II to V) within 30 days according to the Clavien-Dindo classification. The long-term clinical outcome is overall survival within six months postoperative.DiscussionPATRONUS will provide essential insights into the patients’ assessment of their well-being and quality of life in direct relation to clinical outcome parameters following abdominal cancer surgery. Furthermore, PATRONUS will investigate the feasibility of multicentre student-led clinical research.Trial registrationGerman Clinical Trials Register: DRKS00013035 (registered on October 26, 2017).Universal Trial Number (UTN): U1111–1202-8863.
Highlights
One of the most important aspects of designing a clinical trial is selecting appropriate outcomes
Very little is known about the relationship of clinical endpoints including postoperative surgical complications and PRO measures (PROMs) in surgical oncology
Di Cristofaro et al reported no significant relationship between complications and global health-related quality of life (HRQoL) (EORTC QLQ-C30, -CR29) in their prospective trial of 166 patients in 3 centres undergoing colorectal cancer surgery [21]
Summary
One of the most important aspects of designing a clinical trial is selecting appropriate outcomes. There is limited data on how postoperative complications following cancer surgery affect symptoms and HRQoL. For this reason the primary aim of the PATRONUS study is to investigate how perioperative complications affect cancer-related symptoms and HRQoL in patients undergoing abdominal cancer surgery. According to German national data, the most frequent lethal tumour diseases include solid neoplasms of the abdominal cavity including pancreatic, liver, gastric and colorectal cancers [5]. For these tumours, surgery is the mainstay of curative as well as palliative treatment. The design and focus of clinical trials will need to adapt to this changing environment with an increasing need to integrate the patients’ perspective in clinical studies
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