Worldwide urothelial cancer (UC) is one of the most common malignant diseases and causes of death. Patients with UC often have comorbidities, troubling completion of treatment, thus enhancing the need for better supportive instruments during treatment. Patient-reported outcomes (PROs) have been suggested as such, although the use of these has not yet been demonstrated feasible in this aging and comorbid population. Furthermore the literature is sparse on toxicities and quality of life (QoL) during treatment for UC patients outside of clinical trials. This study shall demonstrate the feasibility of electronic reporting of PROs and describe toxicities and QoL in the UC population.
From February 2018, inclusion of patients with UC stage T2-T4NxMx was initiated. All patients initiating chemo- or immunotherapy outside a clinical trial at Rigshospitalet and Herlev Hospital, Denmark, are approached. Recruitment continues until 40 patients are enrolled. All patients will at baseline and weekly during treatment complete four e-questionnaires: EORTC QLQ-C30 & QLQ-BLM30, HADS, selected PRO-CTCAE™ questions and finally three general health questions. Reminders to complete the questionnaires are sent to patients electronically. Clinicians will in turn have an overview of the patients’ answers categorized into groups of severity. The overview is automatically incorporated into the electronic medical charts. The study will evaluate the feasibility of electronic reporting and describe toxicities, QoL, rate of completion and hospital admissions. The results of this study will contribute to the content of a randomized patient-reported outcomes study in the UC population initiated this autumn (2018).
Clinical trial identification
Legal entity responsible for the study
Danish Cancer Society.
All authors have declared no conflicts of interest.