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CTRI Number  CTRI/2023/02/049476 [Registered on: 06/02/2023] Trial Registered Prospectively
Last Modified On: 27/01/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Caregiving burden of parents of children with advanced cancer  
Scientific Title of Study   Validation of the Caregiver Burden Scale & assessment of caregiving burden of parents of children with advanced cancer at a tertiary care set-up in India 
Trial Acronym   
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  Prof and Phy (Psychiatry) Ad Hoc Officer in Charge  
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative Medicine, OPD 75 Tata Memorial Hospital Ernest Borges Road Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  241770007148  
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Scientific Query  
Name  Dr JAYITA DEODHAR 
Designation  Prof and Phy (Psychiatry) Ad Hoc Officer in Charge  
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative Medicine, OPD 75 Tata Memorial Hospital Ernest Borges Road Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  241770007148  
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Public Query  
Name  Dr Manasi Patil 
Designation  PPC Fellow 
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative Medicine, OPD 75 Tata Memorial Hospital Ernest Borges Road Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9324088226  
Fax    
Email  manasipedia@gmail.com  
 
Source of Monetary or Material Support  
TATA MEMORIAL HOSPITAL, Dr Ernest Borges Rd, Parel East, Parel, Mumbai, Maharashtra 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  Dr. Ernest Borges Road, Parel Mumbai 400012 
Type of Sponsor  Research institution and hospital 
 
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  Department of Palliative Medicine, Main Building Ground Floor, OPD 75, Dr. Ernest Borges Road, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA 		 241770007148

jukd2000@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Tata Memorial Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Parents of children with advanced cancer 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Parents of children under 18 referred to the department of palliative medicine, TMH. Inclusion Criteria
1. Can understand Hindi.
2. Should be able to visit/contact the paediatric palliative care clinic, for at least one follow-up.
3. Parents who have cared for their child diagnosed with advanced cancer for at least 3 months.
4. Parents whose children who are on Oral Metronomic Chemotherapy and are following up at or after 3
months in the Paediatric Oncology OPD. 
 
ExclusionCriteria 
Details  1. Children whose prognosis is very poor with a survival time of not more than 15 days.
2. Caregivers with any previous psychiatric conditions or those who are cognitively impaired. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Using the validated CBS, calculation of the mean score to assess the level of caregiver
burden (mild, moderate, or severe). 		 3 months or more 
 
Secondary Outcome  
Outcome  TimePoints 
Reliability of Caregiver Burden Scale using Chronbachs alpha  once 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/02/2023 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Caregiver-burden is important, as the health and well-being of caregivers of patients suffering from cancer or long-term illnesses is shown to directly affect the patient’s and quality of care. There are very few available instruments (like the Zarith Burden Scale, Care of my child with advanced cancer or the Caregiver Difficulties Scale) to measure the caregiver burden of the parents of children with chronic illness or advanced cancer. There is a need to develop scales that are context-appropriate, validated in the local languages and reliable for parents of children with advanced cancer. This study seeks to validate the Caregiver Burden Scale in the local language (Hindi) and assess its applicability to the Indian context. The validated scale will be used to measure caregiver burden in parents of Paediatric patients referred to Paediatric Palliative Unit at TMH.

This study aims to benefit researchers in Paediatric Palliative Care for the planning of and investment into interventions that will prove useful in decreasing caregiver burden and fatigue.

 
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