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CTRI Number  CTRI/2025/07/091887 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 28/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective study 
Study Design  Other 
Public Title of Study   outcomes of interventions after patient admitting to Respite palliative care unit 
Scientific Title of Study   Outcomes of Respite Palliative Care Unit intervention in Patients with Advanced Cancer in an Indian settings: A Retrospective Observational Study 
Trial Acronym  Outcomes, Respite Palliative care, Advanced cancer 
Secondary IDs if Any  
Secondary ID  Identifier 
4870 Version-1.0 Dated-04/06/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jayita Deodhar 
Designation  Head and professor 
Affiliation  Tata Memorial Hospital 
Address  Main Building room no 75 Department of Palliative Medicine Tata Memorial Hospital Dr. E. Borges Marg, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jayita Deodhar 
Designation  Head and professor 
Affiliation  Tata Memorial Hospital 
Address  Main Building room no 75 Department of Palliative Medicine Tata Memorial Hospital Dr. E. Borges Marg, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  TANVI T SHINDE 
Designation  Project Medical officer 
Affiliation  Tata Memorial Hospital 
Address  Main Building room no 75 Department of Palliative Medicine Tata Memorial Hospital Dr. E. Borges Marg Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax  02224177000  
Email  tanvitshinde@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital 
 
Primary Sponsor  
Name  TATA MEMORIAL HOSPITAL 
Address  Department of Palliative Medicine, Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai – 400012 
Type of Sponsor  Government medical college 
 
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  Respite Palliative Care Unit Dr.Ernest Borgesh Memorial Home, Kalanagar, Bandra East
Mumbai (Suburban)
MAHARASHTRA 
0222417000

jukd2000@yahoo.co.uk  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TATA MEMORIAL HOSPTAL  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 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients with advanced/metastatic cancers
Admitted to respite care facility for at least 3 days or more.
 
 
ExclusionCriteria 
Details  Incomplete medical records of patients who are admitted under Respite Palliative Care Unit during study period 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in physical, emotional, well-being, and total ESAS-r scores   from the time of admission and time of discharge  
 
Secondary Outcome  
Outcome  TimePoints 
Secondary:
Duration of stay in days, as mentioned in the departmental records.
Reason for admission at respite palliative care unit as documented in the register/EMR
Documentation of physical, psychological, social & financial intervention done during respite
palliative care unit admission as documented in the register/EMR
Change in performance status at admission & discharge
Documentation of the discharge outcome including referral to hospice or hospital or home or death or
readmission as mentioned in register/EMR
Difference in outcome between patients who are on disease-directed treatment & those who are only
on best supportive care.
Time of discharge to death in days 
Analysis of 3-year medical records from 1st January 2022 to 31st December 2024 
Tertiary:
To evaluate themes from feedback forms 
Analysis of 3-year medical records from 1 st January 2022 to 31 st December 2024 
 
Target Sample Size   Total Sample Size="550"
Sample Size from India="550" 
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)   18/08/2025 
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="3"
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  
Patients with advanced cancer may exhibit a range of symptoms throughout the disease trajectory. The occurrence of the symptoms in patients with advanced cancer can differ in different palliative care settings. Patients may experience more than one symptom. Most patients with cancer experience symptoms, the prevalence and severity of which vary according to the type, stage, and performance status of the cancer. In advanced cancer, 35–96% of patients experience pain, 32–90% experience fatigue, and 10–70% experience breathlessness. High-quality symptom assessment and management are fundamental to providing holistic, patient-centered care that results in positive outcomes for patients and their families. Despite their universality, most symptoms experienced by patients with advanced cancer cane effectively managed using pharmacological and/or nonpharmacological approaches. Therefore, symptom assessment and management are crucial in palliative care. Palliative care is provided through a range of approaches, each designed to address the unique needs of patients and their families in various care settings. Outpatient palliative care clinics serve patients who can visit, even in the earlier stages of illness, by focusing on symptom management and advance care planning. Hospital-based palliative care involves specialised interdisciplinary teams that manage complex symptoms and provide support in inpatient settings. Community-based and home-based models extend care to patient homes, offer continuity, and reduce hospital visits. Hospice care, typically reserved for patients with limited prognosis, emphasises comfort and dignity at the end-of-life. Respite palliative care offers short-term, temporary care for patients to give their primary caregivers a break from their responsibilities. The definition of respite care remains unaddressed in current studies. 
 As per the literature, respite care is involved in providing relief or breaking to caregivers from their caregiving activities, and it can be provided across multiple settings and can include in-home respite such as daytime or overnight care; inpatient care in hospices, nursing homes, or hospitals; or day care. Ingleton et al. described respite as both a service and outcome. Services include inpatient care, day care, and home-based care. It is designed to produce a positive effect on caregivers, enabling them to continue their role. Despite the potential advantages of respite care, research on its efficacy has been extremely limited and has not produced a substantial body of empirical evidence on outcomes, either for caregivers or for people receiving respite(8).In India, respite palliative care is a step-down version of in inpatient unit.
Our Respite Palliative Care Unit [RPCU] is a dedicated quasi-9-bedded inpatient facility 80 meters away from our tertiary cancer care centre. The aim is to provide comprehensive care to patients with advanced cancer and their caregivers. Patients registered under the Department of Palliative Medicine with a performance status of ECOG 0–3 and stable vital parameters, and who have uncontrolled physical symptoms, as well as psychosocial and/or spiritual needs, are eligible for admission to the RPCU. It consisted of a multidisciplinary team of palliative care physicians, nurses, psychologists, social workers, rehabilitation therapists, and volunteers. The RPCU focuses on effective evidence-based symptom management, aiming to enhance the comfort and well-being of both patients and caregivers. In addition to physical care, psychosocial and spiritual care is offered to address the emotional, psychological, and existential needs of patients and caregivers. We also focused on engaging patients and caregivers in meaningful activities that support their physical and psychological well-being during RPCU stay.

Recognising the crucial role of caregivers, the RPCU is equally committed to empowerment and support. Caregivers receive hands-on training in essential skills of care, such as wound dressing and timely administration of medications. We also conducted  family meetings to help reduce caregivers ’distress and emotional fatigue. Regular support group meetings were organised to foster peer learning, shared experiences, and emotional solidarity among the caregivers. Through a combination of
education, emotional support, and skill-building activities, the RPCU strives to create a compassionate environment in which both patients and caregivers are supported, empowered, and equipped to navigate their journey with dignity and resilience. This is the first in its kind in the country and started as a service model since 2019. Hence, this study aimed to provide information regarding the clinical outcomes of patients admitted to an RPCU at a tertiary cancer centre.
 
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