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CTRI Number  CTRI/2025/09/094429 [Registered on: 09/09/2025] Trial Registered Prospectively
Last Modified On: 08/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Study of Psychological distress in Children with Leukemia and Their Parents During Diagnosis and Treatment in India" 
Scientific Title of Study   A Prospective Study on Psychological Distress at Diagnosis and During Treatment in Pediatric Acute Lymphoblastic Leukemia Patients and Their Parents in India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Maharshi Trivedi 
Designation  Associate Professor, Pediatric Oncology 
Affiliation  Gujarat Cancer and Research Institute 
Address  OPD no 102, A wing, Pediatric Oncology Department, Division of Medical Oncology Department, Gujarat Cancer and Research Institute, M. P. Shah Cancer Hospital Campus, New Civil Hospital Road, Asarwa, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  07922688000  
Fax    
Email  dr.maharshi@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Maharshi Trivedi 
Designation  Associate Professor, Pediatric Oncology 
Affiliation  Gujarat Cancer and Research Institute 
Address  OPD no 102, A wing, Pediatric Oncology Department, Division of Medical Oncology, Gujarat Cancer and Research Institute, M. P. Shah Cancer Hospital Campus, New Civil Hospital Road, Asarwa, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  07922688000  
Fax    
Email  dr.maharshi@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Maharshi Trivedi 
Designation  Associate Professor, Pediatric Oncology 
Affiliation  Gujarat Cancer and Research Institute 
Address  OPD no 102, A wing, Pediatric Oncology Department, Division of Medical Oncology, Gujarat Cancer and Research Institute, M. P. Shah Cancer Hospital Campus, New Civil Hospital Road, Asarwa, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  07922688000  
Fax    
Email  dr.maharshi@yahoo.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Maharshi Trivedi 
Address  OPD no 102, Pediatric Oncology OPD, A wing, Gujarat Cancer and Research Institute, M. P. Shah Cancer Hospital Campus, New Civil Hospital Road, Asarwa, Ahmedabad 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Anand Shah  Community Oncology department, Gujarat Cancer and Research Institute, M. P. Shah Cancer Hospital Campus, New Civil Hospital Road, Asarwa, Ahmedabad 
Dr Helie Raval  OPD no 102, A wing, Gujarat Cancer and Research Institute, M. P. Shah Cancer Hospital Campus, New Civil Hospital Road, Asarwa, Ahmedabad 
Dr Priti Sanghavi  Deputy Director office, Gujarat Cancer and Research Institute, M. P. Shah Cancer Hospital Campus, New Civil Hospital Road, Asarwa, Ahmedabad 
Mr Shivam Thakur  Cankids Office, Gujarat Cancer and Research Institute, M. P. Shah Cancer Hospital Campus, New Civil Hospital Road, Asarwa, Ahmedabad 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Maharshi Trivedi  The Gujarat Cancer and Research Institute  OPD no 102, A wing, Pediatric Oncology Department, Division of Medical Oncology, Gujarat Cancer and Research Institute, M. P. Shah Cancer Hospital Campus, New Civil Hospital Road, Asarwa, Ahmedabad
Ahmadabad
GUJARAT 		 9408716111

dr.maharshi@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GCRI/GCS Ethics Committee  Approved 
 
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  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Pediatric patients aged 5–18 years, newly diagnosed with Acute Lymphoblastic Leukemia admitted at Pediatric oncology unit.
2. Child and parent or caregiver must be able to understand and respond to assessment tools in the provided languages.
 
 
ExclusionCriteria 
Details  1. Children previously diagnosed with known pre-existing psychiatric illness/developmental delay/genetic disorder.
2. Caregiver previously diagnosed with known pre-existing psychiatric illness/mood disorders/genetic disorders/1st degree relative with psychiatric illness
3. Children requiring intensive treatment in intensive care unit at the time of diagnosis.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quality of life of patients newly diagnosed with ALL (PedsQLTM scores – total and each in different domains) at diagnosis and after one month of treatment completion with their correlation.   At the time of diagnosis and after one month of treatment completion  
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life of parents/caregivers of patients with ALL (WHOQOL-BREF scores – total & each in different domains) at diagnosis & after one month of treatment completion with their correlation.
Correlation of psychological distress & quality of life measured by PedsQLTM & WHOQOL-BREF scores with clinical/sociodemographic factors.
Correlation of PedsQLTM score with WHOQOL-BREF score measured at diagnosis & after one month of treatment completion.
 		 At the time of diagnosis & after one month of treatment completion  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   22/09/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 focuses on children aged 5 to 18 years newly diagnosed with acute lymphoblastic leukemia and their parents in India. It aims to assess psychological distress and quality of life at diagnosis and one month after starting treatment. Using standard tools like PedsQL questionnaire for pediatric patients and WHOQOL-BREF questionnaire for parents/caregivers of patients, the study will measure emotional and social impacts, identify related sociodemographic factors, and evaluate changes over time of one month of starting treatment. Conducted at Gujarat Cancer and Research Institute over 12 months, the research involves 100 child-caregiver pairs and uses statistical analysis to understand correlations between patient and caregiver well being. 

 
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