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CTRI Number  CTRI/2025/08/093414 [Registered on: 21/08/2025] Trial Registered Prospectively
Last Modified On: 01/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   A Prospective study on delirium in advanced cancer patients coming to emergency department in a tertiary care cancer centre  
Scientific Title of Study   Delirium In Patients With Advanced Cancer ; A Prospective Study In Emergency Department (ED) In A Tertiary Care Cancer Centre  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jayita Deodhar 
Designation  Professor and Head Of Department 
Affiliation  Tata Memorial Hospital Mumbai 
Address  Room no 132, Department of Palliative Medicine, Tata Memorial Hospital, Dr E.Borges Road, Parel, Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9892358023  
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayita Deodhar 
Designation  Professor and Head Of Department 
Affiliation  Tata Memorial Hospital Mumbai 
Address  Room no 132, Department of Palliative Medicine, Tata Memorial Hospital, Dr E.Borges Road, Parel, Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9892358023  
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Public Query  
Name  Dr Prashant Gadgile 
Designation  Junior Resident  
Affiliation  Tata Memorial Hospital Mumbai 
Address  Department of Palliative Medicine Tata Memorial Hospital, Dr E.Borges Road, Parel, Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9146409801  
Fax    
Email  prashantgadgile316@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E.Borges Road, Parel, Mumbai 400012 India 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jayita Deodhar  Tata Memorial Hospital, Mumbai  Department Of Palliative Medicine Main Building 75,Tata Memorial Hospital, Dr E.Borges Road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 		 9892358023

jukd2000@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA
1. Age 18 years and above
2. Diagnosed with advanced cancer
3. Newly referred patients and patients who are already registered with the SPC, who are not on any disease directed treatment, presenting to ED and diagnosed with delirium.
4. Patients able to provide informed consent or consent from legally authorised representative (LAR) if incapable
 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA
1. Patients with preexisting cognitive impairment (ex. Dementia, Alzheimer disease)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•Number and types of causes of delirium as documented on patient assessment records (both electronic and print) will be measured as frequencies and percentages.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
•Frequency of patients presented with symptoms of delirium as documented in emergency and palliative medicine records will be measured as frequencies and percentages.
•The demographic data and most common cancer diagnosis in delirium patients will be measured as frequencies and percentages.
•The time of delirium onset from the diagnosis of advanced cancer will be represented as median score.
•The outcome of palliative care consultation of delirium patients - admission (hospital stay), discharge (home, local hospital, hospice) and death will be measured as frequencies and percentages.
•Survival after 60 days post enrolment weather alive or dead will be represented as frequencies and percentages.
 		 Baseline 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a prospective observational study to identify the cause of delirium in patients with advanced cancer referred to Specialist Palliative Care in Emergency Department enabling early interventions for prevention and management. By identifying common, potentially reversible causes, it can guide timely and appropriate palliative care interventions. It will help to enhance the clinical decision making, symptom management, improve quality of life of patients and reduce unnecessary investigations or hospital stays. The 60 days follow-up data can inform prognosis and long-term care planning, which will contribute to better clinical outcomes.

 
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