Patient'S Perspective Of Living With And Beyond The Treatment Of Trastuzumab: Results From The Persephone Early Breast Cancer Trial.

e22101 Background: PERSEPHONE is a randomised controlled non-inferiority trial comparing 6 months of trastuzumab to the standard 12 months in patients with HER2 positive early breast cancer. An important component of the trial was to collect information about the patients’ journey and their reported unmet needs. Collecting ‘quasi-qualitative’ data via open-ended questions at the end of a questionnaire is becoming increasingly common and championed as a way to add depth to assessments and complement quantitative survey data. Methods: Patients who received trastuzumab as part of the Persephone trial were requested to complete a questionnaire booklet prior to the commencement of trastuzumab, 3-monthly for a year following the start of trastuzumab (regardless of which arm of the trial they were randomised to), then every 6 months up to year 2. The booklet comprised of health resource usage information, general health questions, the EQ-5D and a free text page where patients were invited to record comments about the study or their treatment that they thought the trial team or future patients should know about. Within a mixed methods framework the exploration of the free text page was imported into NVIVO and explored using a thematic content analysis. Results: 4088 patients were randomised between 4th Oct’07 and 31st Jul’15. In total, 5542 experiences from the free text page were recorded from 2456 patients across the 6 different follow-up time-points. Patients offered information on all aspects of the study, including their views on the treatment, their care, the questionnaire they were asked to complete and research itself. The most often mentioned aspects of the study reported were the impact the treatments received had on participants personally - physically, psychologically or socially. By far the most frequently cited that participants wished to make known to others were aches and pains and fatigue; for many, these did appear to be particularly distressing and intractable. Conclusions: Patients experiences during and beyond trastuzumab treatment highlighted the long-term cumulative effects of their treatment and provides rich data to address unmet needs. Clinical trial information: 52968807.