Table 1.

Schedule of enrollment, interventions and assessments (using the SPIRIT template [60]) for the melatonin feasibility study

	Study period
	Enrollment	Allocation	Post-allocation						Close-out
Timepoint	At admission	Within 72 h of admission	Day 1 to Day 28	Day 29 and Day 30	At suspicion of delirium	Delirium diagnosis confirmed	24 (16–32) h after delirium diagnosis	Within 3 days after delirium diagnosis	30-day period after stop of trial product
			(D1–D28)	(D29 + 30)
Enrollment:
Eligibility screen: verbal consent to be contacted by research team member	X
Informed consent		X
Allocation		X
Interventions:
Administer melatonin/placebo			X Daily: @ 21:00 ± 1 h			Discontinue trial product (trial product return/count)
Assessments:
Medical history	X
GOC	X					X
PPS	X
ECS-CP	X
CAM	X				X
SOMCT	X
Nu-DESC	X		X
ESAS-r	X		X
Concomitant medications/NHP	X		X
AE data collection		X	X	X	X	X	X	X
BRP-DICT			X D1 only
CCI			X D1 only
ISI			X D1, 14, 28 ± 2 days
PCU physician CGR						X
MDAS							X
PP-DICT								X
Contact HCP for SAE outcome/death									X

Abbreviations: AE/SAE adverse event/serious adverse event, BRP-DICT Baseline Risk Profile for Delirium in the Cancer Trajectory, CAM Confusion Assessment Method, CCI Charlson Co-morbidity Index, CGR Clinical Global Rating Scale, ESAS-r Edmonton Symptom Assessment System-revised, GOC goals of care, HCP health care professional, ISI Insomnia Severity Index, MDAS Memorial Delirium Assessment Scale, NHP Natural Health Product, Nu-DESC Nursing Delirium Screening Scale, PCU palliative care unit, PP-DICT Precipitant Profile for Delirium in the Cancer Trajectory, PPS Palliative Performance Scale, SOMCT Short Orientation Memory Concentration Test