Schedule of events for quality-of-life measures (collected through eCRFs (electronic Case Report Forms)) during the FINESSE trial
Treatment phase (years 1–2) | Follow-up phase (years 3–5) | ||||||||||||||||
Timepoint in months (visit can be±2 weeks). | |||||||||||||||||
Completed by participants on FINESSE web-based EDC, (REDCap) | Randomisation | 3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 | 30 | 36 | 42 | 48 | 54 | 60 | Early withdrawal | |
Quality of life measures | EQ-5D-5L | x | x | x | x | x | x | x | x | x | x *† | ||||||
EORTC QLQ C30 | x | x | x | x | x | x | x | x | x | x *† | |||||||
EPIC | x | x | x | x | x | x | x | x | x | x*† | |||||||
EORTC QLQ FA12 | x | x | x | x | x | x | x | x | x | x*† | |||||||
Memorial Anxiety Scale Prostate Cancer | x | x | x | x | x | x | x | x | x | x*† | |||||||
Depression Anxiety Stress Scales (DASS) 21 | x | x | x | x | x | x | x | x | x | x*† | |||||||
Decision-making measures | Decisional Conflict Scale | x | x | x | x | x | x | x*† | |||||||||
Subjective Decision Quality | x | x | x | x | x | x | x*† | ||||||||||
Decisional Regret | x | x | x | x | x | x | x*† | ||||||||||
Decisional Involvement | x | x | x | x | x | x | x*† | ||||||||||
Adherence | Voils DOSE-Non adherence measure | x | x | x | x | x | x | x | x | x ‡ |
*Where a participant stops treatment and/or trial participation early, due to radical treatment, they will continue to receive these questionnaires for completion, for the remainder of their intended period of follow-up, providing they consent to do so. The exception for this group is the ‘Decisional Conflict Scale’ which will not be assessed again, and the decisional involvement scale which will only be administered once more, post radical therapy.
†Where a participant stops treatment and/or trial participation early, for any reason other than radical treatment, they will continue to receive these questionnaires for completion, for the remainder of their intended period of follow-up, providing they consent to do so.
‡If the participant is still on treatment at the point of early withdrawal, one final Voils DOSE-Nonadherence measure—Extent Scale will be sent for completion.