ABSTRACT
Aims: For cancer patients with oligo metastatic disease (OMD), defined as five metastases or less, a more aggressive treatment approach has been suggested. In SOFT, an international multicenter phase II trial, patients with OMD and infra-diaphragmatic soft tissue metastases were treated with online MR-guided stereotactic ablative radiotherapy (SABR). To better identify early adverse events related to SABR, longitudinal collection of electronic patient-reported outcomes (ePROs) were included. As this is a short-course treatment in an elderly population our aim was to report the feasibility of continuous ePRO for the first 100 patients. Method(s): Patients were enrolled at four sites;Herlev Hospital, Rigshospitalet, Odense University Hospital in Denmark, and Henry Ford Hospital, Detroit. They were allocated to 3-8 radiotherapy fractions depending on target site and dose to organs at risk. Early toxicity was measured with eight symptomatic AEs from the PRO-CTCAE item library and quality of life with the EUROqol EQ-5D-5L at pre-specified time points (Fig. 1). A link to the ePRO system (REDCap) was sent out electronically. In case of no computer access, a paper version was provided. The invitation was re-send after 2 days. No back-up call was provided. Result(s): The first 100 patients having reached a 24-week follow-up evaluation were included in the analysis. Five patients had a second enrollment (105 enrollments) and 19 had more than one target. The median age was 70 years. The majority were men (67%) and had oligo metastatic recurrence (54%) (Table 1).The consent rate for ePRO completion was 87% (91 electronic/13 paper/1 declined). For an elderly population with metastatic cancer, the overall adherence level to PRO completion was high (88%) and the high level remained until week 24 (retention rate 91%) (Fig. 2). Only 44% of the paper questionnaires were completed week 24. This may partly be due to in-person visits being changed to telephone consults during COVID-19. Four patients (4%) reported technical difficulties. Conclusion(s): Collecting ePROs among elderly cancer patients with OMD having short-course radiotherapy is feasible. All but one patient completed PROs with the majority doing electronic reporting. Overall, adherence was high except for patients completing paper-based PROs.