| CTRI Number |
CTRI/2025/10/095789 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Demographics and symptom burden of patients with advanced chronic diseases referred to palliative medicine in a tertiary hospital: an observational exploratory study |
|
Scientific Title of Study
|
Demographics and symptom burden of patients with advanced chronic diseases referred to palliative medicine in a tertiary hospital: an observational exploratory study |
| 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. Rashik Prajapati |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Onco-Anaesthesia and Palliative Medicine, Room no 135A, 1st Floor, DR B.A.I.R.C.H Building, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
6287137505 |
| Fax |
|
| Email |
rashikpraz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Garg |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Onco-Anaesthesia and Palliative Medicine, Room no 135A, 1st Floor, DR B.A.I.R.C.H Building, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810394950 |
| Fax |
|
| Email |
drrgarg@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Garg |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Onco-Anaesthesia and Palliative Medicine, Room no 135A, 1st Floor, DR B.A.I.R.C.H Building, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810394950 |
| Fax |
|
| Email |
drrgarg@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Department of Onco-Anaesthesia and Palliative Medicine, Room no 135A, 1st Floor, DR B.A.I.R.C.H Building, Ansari Nagar, New Delhi, India 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rashik Prajapati |
All India Institute of Medical Sciences New Delhi |
Department of Onco-Anaesthesia and Palliative Medicine, Room no 135A, 1st Floor, DR B.A.I.R.C.H Building, Ansari Nagar, New Delhi
New Delhi
DELHI |
6287137505
rashikpraz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients age more than 18 years and older.
Patients capable of providing informed consent.
Patients who are referred to hospital palliative care team during their current hospitalization. |
|
| ExclusionCriteria |
| Details |
Patients with severe cognitive impairment or altered mental status that prevents them from providing reliable information, even with the assistance of a caregiver.
Patients who do not understand Hindi or English.
Patients not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the demographic profile and symptom burden using the Edmonton Symptom Assessment System-revised (ESAS-r) tool among patients suffering from chronic diseases referred to the Palliative Medicine for palliative care service |
single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the quality of life assessed using the 36-Item Short Form Survey (SF-36) among patients suffering from chronic diseases referred to the Palliative Medicine for palliative care services.
To assess the impact on symptom burden (by assessing using the Edmonton Symptom Assessment System-revised (ESAS-r) tool and its change over the time period) after Palliative Medicine consultation at the baseline level (Day 1) and Day 7 or on the day of discharge (whichever is earlier)
|
baseline level (Day 1) and Day 7 or on the day of discharge (whichever is earlier) |
|
|
Target Sample Size
|
Total Sample Size="553"
Sample Size from India="553"
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)
|
29/10/2025 |
| 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="1"
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
|
The study is about looking at what kind of demographics patients are being referred to palliative care services along with their symptom burden. Current researches that have largely focused on specific disease population creating a fragmented understanding of who receives palliative care and what symptoms they experience. There would be higher number of symptom burden in patients who are referred to palliative care services. |