Given that this is a feasibility study, we will not conduct hypothesis testing to determine if either treatment option has a greater impact on HRQOL. Instead, analyses will be descriptive, focusing on calculating confidence intervals for key trial parameters.23 For example: (1) estimating eligible participant numbers, recruitment, fidelity and attrition rates, rate of missing data; (2) estimating the SD for HRQOL and likely trajectory over time, in order to inform/refine a sample size calculation for a future phase III trial and (3) determining whether the study design was acceptable to participants and their caregivers. A feature of the study data will be that some participants will have their HRQOL outcomes censored due to death. The study will allow us to estimate the frequency of this occurring, and to develop an analytical strategy for a phase III trial. We plan to use joint modelling techniques (joineR package in R24), which allows for the joint analysis of survival data and endogenous repeated measures. Our analysis will focus on estimating variability, correlation between repeated measurements from the same individual and modelling the trajectory of HRQOL over time. We will adjust for baseline functional status. We will use the data from this study to design a detailed analysis plan for a confirmatory study. Qualitative data generated from the audiorecorded interviews with patient–carer dyads and clinicians will be analysed using framework analysis.25 Audiorecordings of recruitment consultations will be analysed using content analysis26 to highlight specific issues and enable immediate feedback to the trial management group.

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