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CTRI Number  CTRI/2020/12/029960 [Registered on: 21/12/2020] Trial Registered Prospectively
Last Modified On: 21/12/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective Study 
Study Design  Other 
Public Title of Study   looking at care received by children with cancer in India in the last few days of their life 
Scientific Title of Study   Patterns of End-Of-Life Care in Children with Cancer in India - A Multicentre Retrospective Study  
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gayatri Palat 
Designation  Consultant Department of Palliative Medicine 
Affiliation  MNJ Institute of Oncology and RCC and Founder Member Pain Relief and Palliative Care Society 
Address  Room 34 1st Floor Department of Pain and Palliative Medicine MNJ Institute of Oncology and Regional Cancer Centre Hyderabad Telangana State
-
Hyderabad
TELANGANA
500004
India 
Phone  9985480614  
Fax    
Email  gpalat@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gayatri Palat 
Designation  Consultant Department of Palliative Medicine 
Affiliation  MNJ Institute of Oncology and RCC and Founder Member Pain Relief and Palliative Care Society 
Address  Room 34 1st Floor Department of Pain and Palliative Medicine MNJ Institute of Oncology and Regional Cancer Centre Hyderabad Telangana State
-
Hyderabad
TELANGANA
500004
India 
Phone  9985480614  
Fax    
Email  gpalat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gayatri Palat 
Designation  Consultant Department of Palliative Medicine 
Affiliation  MNJ Institute of Oncology and RCC and Founder Member Pain Relief and Palliative Care Society 
Address  Room 34 1st Floor Department of Pain and Palliative Medicine MNJ Institute of Oncology and Regional Cancer Centre Hyderabad Telangana State
-
Hyderabad
TELANGANA
500004
India 
Phone  9985480614  
Fax    
Email  gpalat@gmail.com  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  Pain Relief and Palliative Care Society 
Address  Pain Relief and Palliative Care Society Kumudini Devi Hospice No. 1-6 New Vivekananda Nagar colony pillar no 777 Kukatpally Hyderabad 
Type of Sponsor  Other [Non Governmental Organization] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Veronique Dinand   Bai Jerbai Wadia Hospital for Children   Head Palliative and Supportive Care Unit Bai Jerbai Wadia Hospital for Children Parel Mumbai
Mumbai
MAHARASHTRA 		 9971839244

verodinand@gmail.com 
Dr Ramandeep Singh Arora   Max Super Speciality Hospital   Department of Medical Oncology Max Institute of Cancer Care A Unit of Devki Devi Foundation Saket New Delhi
East
DELHI 		 8375017305

childhoodcancer@gmail.com 
Dr Gayatri Palat  MNJ Institute of oncology and Regional Cancer Centre  Room No. 34, Department of pain and palliative care, MNJIORCC Red Hills Lakdikapul Hyderabad 500004
Hyderabad
TELANGANA 		 9985480614

gpalat@gmail.com 
Dr Spandana Rayala  Pain Relief and Palliative Care Society  Ground Floor, Pain and Palliative Care Unit, Kumudini Devi Hospice No.1-6 pillar 777 New Vivekananda Nagar Colony Kukatpally Hyderabad
Hyderabad
TELANGANA 		 9618131366

spandanarayala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Devki Devi Foundation  Submittted/Under Review 
Ethics committee, Bai Jerbai Wadia Hospital for Children  Submittted/Under Review 
MNJ Ethics Committee   Approved 
Pain Relief and Palliative Care Society  Not Applicable 
 
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 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. All patients less than 18 years
2. AND Poor prognostic cancer which is defined as
a. Stage IV cancer at diagnosis
b. Progressive disease, either primary refractory, or following relapse
c. Newly diagnosed cancer, child unfit for treatment due to poor general condition at
presentation
3. AND Died during the study period (Jan 1, 2017-Dec 31, 2019)
4. AND Died either at healthcare facilities (hospital or hospice) OR died at home (only for children
who received community-based palliative care services) 
 
ExclusionCriteria 
Details  1. Death at home where no community-based palliative care service was involved
2. Inadequate records (as defined in central document) 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Receipt of cancer-directed treatments (chemotherapy/radiotherapy) and high intensity care at the
end of life(CPR, intubation/mechanical ventilation, renal replacement therapy (dialysis),
parenteral nutrition, inotropes, terminal ICU admission) 		 01-01-2017 to 31-12-2019 
 
Secondary Outcome  
Outcome  TimePoints 
1. Location and cause of death (disease vs treatment-related)
2. Presence of and treatments for pain and other symptoms at the end of life
3. Referral for or provision of specialist palliative care service and/or other forms of psychosocial support
4. Characteristics of communication with family about prognosis, treatment options and appropriate goals of care at end of life
5. Participating organizations’ capacity and infrastructure  		 01-01-2017 to 31-12-2019 
 
Target Sample Size   Total Sample Size="780"
Sample Size from India="780" 
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)   02/08/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 There are an estimated 50,000 children (0–18 years of age) diagnosed with cancer annually in India, with an estimated five-year survival of 37–40%. More than half of these children die, either of disease or from treatment toxicity. Palliative care aims at relieving physical, emotional, social and spiritual suffering during the continuum of the cancer journey including end-of-life. It is considered integral to cancer care for children in all settings, and the benefits of pediatric palliative care at improving symptom management and reducing inappropriate use of high-intensity care is well described in high-income countries (HIC). Studies from low-and middle-income countries (LMIC)are essential to define the global need for pediatric palliative care, since the demographics of suffering and death are expected to differ and so must the provision of pediatric palliative care. For children with cancer who die in India, there are very limited data on the availability or provision of palliative care. This multicentric observational retrospective Indian Pediatric Oncology Group (InPOG) study aims to describe the patterns of end-of-life care and demographics of children with cancer who die at health facilities and at home(for children who received community-based palliative care services)in India during a five time period (Jan 1, 2017 - Dec 31, 2021). Participating centres will include hospitals (public, private, trust) which are treating children with cancer, as well as hospices/palliative care facilities, and community-based palliative care services which provide care for children with cancer, with broad geographical representation from across India. Data regarding demographics, cancer diagnosis, cause of death, symptoms experienced in the last 2 days of life, tumor-specific and symptomatic treatments, palliative care referral, family counselling and end-of-life discussions will be collected. Intensity of lifesustaining therapy (tumor-specific treatments and high intensity therapy) and symptom management at the end-of-life will be compared with accessibility to specialized palliative care services. A sample size of 780 will allow us to describe patterns of end-of-life care in children with cancer in India and also specifically examine that involvement of a specialized palliative care team is associated with a 20% reduction in high intensity care in these patients. 
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