| CTRI Number |
CTRI/2026/02/103947 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational |
| Study Design |
Other |
|
Public Title of Study
|
A Prospective study on reasons for Admission, Symptoms and Proportion of discharge in Advanced Cancer patients admitted in Palliative Care Ward |
|
Scientific Title of Study
|
OUTCOMES, REASONS OF ADMISSIONS AND SYMPTOM PROFILE
OF ADVANCED CANCER PATIENTS ADMITTED IN AN INPATIENT
PALLIATIVE CARE UNIT IN TERTIARY CANCER CENTRE IN LOW-
MIDDLE-INCOME COUNTRY- A PROSPECTIVE OBSERVATIONAL
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 Jayita Deodhar |
| Designation |
Professor and Head |
| Affiliation |
Tata Memorial Hospital ,Mumbai |
| Address |
Room no 132, MB 75 ,Department of Palliative medicine Tata Memorial Hospital , Parel ,Mumbai
400012 Mumbai MAHARASHTRA 400012 India |
| Phone |
9892358023 |
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dipa Amte |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Hospital ,Mumbai |
| Address |
Room no 132, MB 75 ,Department of Palliative medicine Tata Memorial Hospital , Parel ,Mumbai, 400012 Mumbai MAHARASHTRA 400012 India |
| Phone |
8830957087 |
| Fax |
|
| Email |
dipaamte05@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jayita Deodhar |
| Designation |
Professor and Head |
| Affiliation |
Tata Memorial Hospital ,Mumbai |
| Address |
Room no 132, MB 75 ,Department of Palliative medicine Tata Memorial Hospital , Parel ,Mumbai
400012 Mumbai MAHARASHTRA 400012 India |
| Phone |
9892358023 |
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr E. Borges Road ,Parel, Mumbai - 400012 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Jayita Deodhar |
Tata Memorial Hospital |
Room no 132 , Main building 75 no OPD , Tata Memorial Hospital, 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 I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
1. Patients diagnosed with advanced cancer admitted to the Inpatient Palliative Care Unit (IPCU).
2. Age more than or equal to 18 years.
3. Able to communicate and understand English, Hindi, or Marathi, and willing to provide informed consent.
4. If a patient is unable to provide consent, consent is obtained from a legally authorized representative (LAR). |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients discharged from the Inpatient Palliative Care Unit (IPCU). |
At the time of discharge . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reasons for Admission: Frequency and percentage of reasons for IPCU
admission as documented in patient admission notes or electronic medical records
(EMR). |
Day 0 |
| Symptom Burden at Admission: Frequency and percentage of symptoms at the time of admission, assessed using the ESAS-r scale. |
Day 0 |
| Symptom Change Over Time: Change in symptom severity scores on day 3 and at discharge compared with baseline (day 0), measured using ESAS-r scores. |
Day 0, day 3 and discharge |
| Investigations Performed: Frequency and percentage of diagnostic investigations conducted during IPCU admission as per inpatient records or EMR documentation. |
Day 0 till discharge |
| Medications Used: Frequency and percentage of various medications administered during the IPCU stay based on inpatient records or EMR documentation. |
Day 0 till discharge |
Medical Procedures performed : Frequency and percentage of medical
procedures performed during IPCU admission as per inpatient records or EMR. |
Day 0 till discharge |
| Referrals given :Frequency and percentage referrals with support services (e.g., physiotherapy, occupational therapy, dietetics, psychology) during the IPCU stay, as documented in the records or EMR. |
Day 0 till discharge |
Length of Stay: Median duration (in days) of IPCU hospitalization, as
recorded in inpatient records or EMR. |
Day 0 till discharge |
Post-discharge Survival: Number and percentage of patients surviving 30
days post-discharge, assessed through telephonic follow-up. |
30 days post-discharge |
Predictive Factors for Survival: Analysis of associations between baseline
demographic, clinical, and treatment-related variables (such as age, performance
status, and type of malignancy) and overall post-discharge survival. |
Day 0 till discharge |
|
|
Target Sample Size
|
Total Sample Size="55" Sample Size from India="55"
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)
|
27/02/2026 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 single-centre, prospective observational study conducted at the Inpatient Palliative Care Unit (IPCU) of Tata Memorial Hospital, Mumbai. The study aims to assess the outcomes, reasons for admission, and symptom profile of adult patients with advanced cancer admitted to the IPCU over a 12-month period. A minimum of 55 patients will be enrolled. Symptom burden will be assessed using the Edmonton Symptom Assessment Scale–Revised (ESAS-r) at admission (Day 0), Day 3, and at discharge. The primary outcome is the proportion of patients discharged from the IPCU. Secondary outcomes include reasons for admission, symptom changes during hospitalization, investigations performed, medications used, procedures conducted, length of stay, and 30-day post-discharge survival (assessed via telephonic follow-up). This study addresses a significant gap in Indian palliative care research by prospectively evaluating IPCU admissions and outcomes in a low- and middle-income country setting, with the goal of improving resource planning and quality of care delivery. |