Short summary

Magnetic resonance-guided (MR-guided) radiotherapy is a new cutting-edge technology in cancer treatment. The improved visualization with MR-images opens up for a reduction of safety margins needed to insure target coverage and possibly hypofractionated dose escalation to the tumor. This study is the first substudy in a PhD study aiming to elucidate and create new knowledge about acute patient reported toxicity to MR-guided radiotherapy in the pelvic area by incorporating web-based patient reported outcome (PRO) into the clinical radiotherapy workflow. 

Rationale

Odense University Hospital (OUH) is the 5th site worldwide to treat patients with the new MR-Linac. The MR-Linac is innovative technology in cancer treatment making precision radiotherapy possible on the first high-field 1.5 Tesla MR Linac. The MR Linac is a linear accelerator mounted on a ring around a 1.5-Tesla MRI Scanner combined with an online adaptive radiotherapy planning system. When the patient is positioned in the MR-Linac it is possible to get real-time MR images with high soft tissue contrast, adapt the radiotherapy plan and subsequently irradiate at each treatment fraction. The improved visualization on the MR images makes it possible to see how the tumor and the organs around it changes and adapt the treatment plan every day. The improved visualization opens up for a reduction of safety margins needed to insure target coverage and possibly hypofractionated dose escalation to the tumor. Hopefully, the patients will benefit from this with decreased toxicity and increased local tumor control rates. In 2019 three MR-accelerators will be available for MR-guided radiotherapy in Denmark. This puts this research field at great immediate interest.

Patients diagnosed with cancer in the pelvic region, like prostate cancer, have considerably high chances of survival. Therefore, new technology potentially lowering side-effects from radiotherapy can have a great impact on survivorship and quality of life of these patients. Prospective evaluation of clinical effectiveness outcome to MR-guided radiotherapy is therefore necessary. Several studies have indicated that the severity of toxicity reported directly by the patient (PRO) is higher than those reported by clinicians and also without clinician interpretation. Therefore, PRO can be an accurate measure for evaluating MR-linac treatment. 

The aim of this PhD study is to elucidate and create new knowledge about acute patient reported toxicity to radiotherapy in the pelvic area by incorporating web-based PRO into the clinical radiotherapy workflow. In the Region of Southern Denmark the app My Patient Pathway is a downloadable app usable for PRO-registration allowing patient reported outcome to be transferred directly to the electronic health record (EHR). In this first substudy we will investigate the feasibility of a disease-specific subset of PRO and quality of life questions and examine the patient experience of an electronic PRO-based patient pathway for symptom management. It is a feasibility study with mixed methods (n=50) starting with a review of relevant literature on adverse events to identify and select relevant symptomatic adverse events for patient and radiotherapy staff evaluation. The feasibility study is expected to systematically define and estimate the relevant symptoms and the technical feasibility, acceptability and clinical utility of a web-based PRO registration needed to design the prospective observational cohort study (study 2). 

Discrepancies between younger and elderly patients will be investigated. A special focus of the study will be how this digital involvement and inclusion of the patients suits an ageing population with increasing multi-morbidity. The results from this study will be among the first knowledge on patient-reported toxicity and experiences regarding MR-linac treatment.

Description of the cohort

Patients with sub-diaphragmatic primary tumours or metastases being treated with magnetic resonance guided radiotherapy or conventional linear accelerators at Odense University Hospital being over the age of 18 (n=50) 

Data and biological material

A disease-specific subset of PRO-CTCAE items potentially combined with other relevant adverse events will be used to collect data on patient-reported outcome. The Patient Evaluation Form (questionnaire), semi-structured patient interviews and radiotherapy staff focus group interviews will be used for evaluation the feasibility study. 

Collaborating researchers and departments

Department of Oncology, Odense University Hospital. 

• Associate Professor Karin Brochstedt Dieperink, RN, PhD
• Consultant Associate Professor Tine Schytte, MD, PhD
• Associate Professor Uffe Bernchou, MSc, PhD

Finsencentret, Rigshospitalet

• Senior Consultant Helle Pappot, MD, DMSc