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Table 1 Schedule of enrollment, interventions and assessments (using the SPIRIT template [60]) for the melatonin feasibility study

From: The preventative role of exogenous melatonin administration to patients with advanced cancer who are at risk of delirium: study protocol for a randomized controlled trial

 

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

  1. 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