| 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
|
|
|
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
|
|
|
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
|
|
|
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. |