Table 4 Primary measures

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