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CTRI Number  CTRI/2025/12/098495 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 03/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Qualitative study 
Study Design  Other 
Public Title of Study   Exploring the perspectives of children labelled cancer survivors to understand their participation and inclusion in their communities in South India 
Scientific Title of Study   Reframing occupational participation and social inclusion of children labelled cancer survivors in South India: A participatory ethnography 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Leni Grace Mathew 
Designation  Senior Professor 
Affiliation  Christian Medical College 
Address  Department of Pediatric Hematology-Oncology, Child Health Unit I Office, 5th Floor, ISSCC Building Christian Medical College Town Campus, Ida Scudder Road

Vellore
TAMIL NADU
632004
India 
Phone  9500921016  
Fax    
Email  lenimathew@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Leni Grace Mathew 
Designation  Senior Professor 
Affiliation  Christian Medical College 
Address  Department of Pediatric Hematology-Oncology, Child Health Unit I Office, 5th Floor, ISSCC Building Christian Medical College Town Campus, Ida Scudder Road


TAMIL NADU
632004
India 
Phone  9500921016  
Fax    
Email  lenimathew@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Leni Grace Mathew 
Designation  Senior Professor 
Affiliation  Christian Medical College 
Address  Department of Pediatric Hematology-Oncology, Child Health Unit I Office, 5th Floor, ISSCC Building Christian Medical College Town Campus, Ida Scudder Road


TAMIL NADU
632004
India 
Phone  9500921016  
Fax    
Email  lenimathew@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Christian Medical College 
Address  Christian Medical College Ida Scudder Road Vellore,Tamil Nadu 632004 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Leni Grace Mathew  Christian Medical College  Department of Pediatric Hematology-Oncology, Child Health Unit I Office, 5th Floor, ISSCC Building Christian Medical College Town Campus, Ida Scudder Road
Vellore
TAMIL NADU 		 9500921016

lenimathew@cmcvellore.ac.in 
Sooraj S  Prajaahita Foundation  12/133 Gas Godown Road Palappuram Ottapalam 679103
Palakkad
KERALA 		 9746691997

soorajs@prajaahita.org 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Review Board,Christian Medical College,Vellore  Approved 
Prajaahita Foundation  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Children regardless of their cancer category who were diagnosed with cancer in the year 2021 or after (to provide recency in reflecting on their experiences).
2. Age 12-18 years. The minimum age of 12 is to capture the breadth of life experience they would possess and the maximum age of 18 is according to the legal definition of children according to the Juvenile Justice (Care and Protection of Children) Act 2015 issued by the Government of India (Ministry of Women &Child Development, 2024)
3. Children who are aware of the diagnosis as reported by the caregiver or parent will only be recruited.
4. Children who completed their intensive biomedical treatment in the hospital returned to their own homes and restarted participation in the community including schooling.
5. Children who are receiving (e.g. in the maintenance phase of chemotherapy requiring no long-stay hospital admission or attending yearly follow-up) or have received care from CMC.
6. Children from Kerala or Tamil Nadu who can speak English Tamil or Malayalam will be recruited.  
 
ExclusionCriteria 
Details  1. If the healthcare professional and or or caregiver or parent suggest that participation in the study poses a potential risk (e.g. psychological or emotional disturbances) to the child.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To obtain knowledge about occupational
participation and social inclusion of children labelled cancer survivors in South India through their perspectives. 		 At one year after initiation of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
To obtain knowledge about children & childhoods and
rethinking equitable & justice oriented health services & inclusion policies for children labelled cancer survivors in India 		 One year after initiation of treatment 
 
Target Sample Size   Total Sample Size="8"
Sample Size from India="8" 
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)   15/12/2025 
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="0"
Months="8"
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 study is a participatory ethnography that seeks to understand the occupational participation and social inclusion of children labelled cancer survivors through their perspectives to construct a situated and contextualized knowledge about their childhoods. The study aims to advance the knowledge about children labelled cancer survivors and their childhoods in India through the following research questions: 1) How do children labelled cancer survivors construct and negotiate their identities as children and cancer survivors in and through their occupational participation? 2) How is occupational participation related to the experience of social inclusion in children labelled cancer survivors?

 
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