Optimising Individual Treatment Regimes and Patient Outcomes through the Use of Patient-Reported Toxicity Assessments in Patients treated with Pelvic Radiotherapy

The primary objectives of this thesis are to develop a systematic method for patients to self-report pelvic radiotherapy adverse events (AE) using electronically collected patient reported outcomes (PROs) in clinical practice and to evaluate patient-reported toxicity in association with radiotherapy dosimetric data and clinical factors.

Before testing the research objectives in two observational studies, important practical and methodological issues were addressed. Analysis from systematic and literature reviews, content analysis of three validated PRO systems and interviews with health professionals found the European-Organisation-for-Research-and-Treatment-of-Cancer-Quality-of-Life-Questionnaires (EORTC-QLQ) C30 and cancer-specific modules to have the most effective coverage of acute and late AE for patient treated with radiotherapy for anal, rectal, endometrial and cervical cancer. Qualitative analysis of patient cognitive interviews found the EORTC-QLQ system was acceptable to patients and revealed discrepancies in toxicity grading between patient and clinician (using the Common-Terminology-Criteria-of-Adverse-Events (CTCAE)) might be due to inherent differences in the grading descriptions between the scoring systems. Electronic methods for collection and presentation of PRO data were developed alongside technology to improve clinical data capture from electronic health records (EHR). A pilot study of 31 patients proved it was feasible to collect electronic and paper PRO data and integrate results into individual EHRs. A protocol for organ at risk (OAR) contouring and methods used for dose-volume-histogram (DVH) export were developed.

The cross sectional (n=315) and prospective studies (n=129) found bowel urgency and sexual dysfunction to be the late AE most commonly reported by patients. The cross sectional study piloted the application of principal component analysis to describe DVH data from patients treated with multiple radiation techniques and demonstrated associations between PRO late toxicity and dosimetric and clinical data. The prospective study interim analysis found resolution of many treatment-related symptoms by six-months and provided encouraging findings for the use of longitudinal PRO collection in routine practice.