Outcome domain | Measure | Definition |
---|---|---|
Feasibility | Adherence to medication regimen | Compliance with study treatment (at minimum 80% of doses taken indicates feasibility, i.e. 11 out of 13 doses taken) |
Attendance at MCP session | Percentage of participants attending 4 out of 7 sessions | |
MCP treatment fidelity | Rating on the Memorial Sloan Kettering Fidelity Rating Scale. A 5-item yes/no indicating presence of content, a 5-item 3-point Likert scale measuring coverage, and a final 5-point Likert scale assessing overall focus on meaning/purpose | |
Participant recruitment | Percentage of consented participants randomised (70% or greater indicates feasibility) | |
Attrition | Number of dropouts following randomisation (30% or less indicates feasibility) | |
Acceptability | Qualitative interviews | Semi-structured qualitative interviews at baseline and at 1 month following treatment completion (T8) (participant and support person) and will address expectations and the acceptability of study procedures |
Completeness of data | Percentage of complete data | |
Safety | Vital signs | Monitoring of vital signs including heart rate, blood pressure, and body temp at 0, 30, 120, 240, and 360 min post-administration at T1. Also measured at 0- and 45-min post-administration, for T2–T7. Serotonin syndrome checks on every in-clinic day T1–T7 |
Palliative Care Outcomes Collaborative Symptom Assessment Scale (PCOC-SAS) | Nine symptom items on an 11-point scale of distress, rated from ‘absent’ to ‘severe’ | |
Adverse events | Participants are asked on dosing days to report any ‘unpleasant health effects’ and to rate them as mild, moderate, or severe | |
ECG data | ECG data will be reviewed by a study physician, noting where reference ranges are exceeded |