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CTRI Number  CTRI/2024/11/076739 [Registered on: 13/11/2024] Trial Registered Prospectively
Last Modified On: 25/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of Cognitive Behaviour Therapy compared to Integrated Cognitive Behaviour and Art Based Therapy on Automatic thought, Distress, Depression, Anxiety and Quality of Life among Children with cancer  
Scientific Title of Study   Comparative study on impact of Cognitive Behavioural Therapy with Integrated Cognitive Behavioural and Art Based Therapy on Distress Cognitive distortions, Depression, Anxiety, Hope and Quality of Life among Children with cancer  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kavitha Dhanaraj 
Designation  PhD Scholar (Part time) 
Affiliation  University of Madras 
Address  Department of Psycho-oncology Cancer Institute (WIA), Adyar 3rd Floor 38, Sardar Patel Road, Nehru Nagar, Chennai

Chennai
TAMIL NADU
600022
India 
Phone  9840244405  
Fax    
Email  kavithadhanaraj@jbascollege.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Kavitha Dhanaraj 
Designation  PhD Scholar Part time 
Affiliation  University of Madras 
Address  Department of Psycho-oncology Cancer Institute (WIA), Adyar 3rd Floor 38, Sardar Patel Road, Nehru Nagar, Chennai

Chennai
TAMIL NADU
600018
India 
Phone  9840244405  
Fax    
Email  kavithadhanaraj@jbascollege.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr V Surendran 
Designation  Professor and Head 
Affiliation  University of Madras 
Address  Department of Psycho-oncology Cancer Institute (WIA), Adyar 3rd Floor 38, Sardar Patel Road, Nehru Nagar, Chennai

Chennai
TAMIL NADU
600022
India 
Phone  9444152231  
Fax    
Email  v.surendran@cancerinstitutewia.org  
 
Source of Monetary or Material Support  
Cancer Institute, Adyar (W.I.A), 38, Sardar Patel Road, Nehru Nagar, Chennai 600022 
 
Primary Sponsor  
Name  Cancer Institute WIA 
Address  Cancer Institute (W.I.A), Adyar,38, Sardar Patel Road, Nehru Nagar,Chennai-600022,Tamilnadu,India 
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 
Prof Dr V Surendran  Cancer Institute (WIA), Adyar  Department of Psycho-oncology Cancer Institute (WIA), Adyar 3rd Floor 38, Sardar Patel Road, Nehru Nagar, Chennai
Chennai
TAMIL NADU 		 9444152231

v.surendran@cancerinstitutewia.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Cancer Institute (WIA) Institutional 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 
Comparator Agent  Cognitive Behavior therapy  6 sessions of Cognitive behavior therapy 40 minutes each session 
Intervention  Integrated Cognitive Behavior and Art Based therapy  6 sessions of Integrated Cognitive Behavior and Art Based therapy 60 minutes each session 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Medical fitness by Oncologist to undergo CBT and Art based therapy
IQ above 90
Distress score 4 and above
Tamil and or English speaking 
 
ExclusionCriteria 
Details  Labelled as Medical unfit by Oncologist to undergo CBT and Art based therapy
IQ below 90
Distress score below 4
Other than Tamil and or English speaking 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the level of Distress, Anxiety, Depression, Automatic thoughts and Quality of life among children with cancer  One week post intervention
One month post intervention
Six months post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
To understand the types of Automatic thoughts among children with cancer with respect to the diagnosis and treatment  One week post intervention
One month post intervention
Six months post intervention 
To understand the relationship between Automatic thoughts, Distress, Anxiety, Depression, and Quality of life among children with cancer  One week post intervention
One month post intervention
Six months post intervention 
To compare the effectiveness of Cognitive Behaviour Therapy with Integrated Cognitive Behaviour and Art based therapy in reducing Automatic thoughts, Distress, Anxiety, Depression and enhancing Quality of life among children with cancer  One week post intervention
One month post intervention
Six months post intervention 
 
Target Sample Size   Total Sample Size="186"
Sample Size from India="186" 
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   Phase 3 
Date of First Enrollment (India)   10/10/2025 
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  
A trained psycho oncologist after obtaining consent, will conduct the first baseline assessment - the level of Distress(using the Paediatric Distress thermometer) experienced by the child (ENGLISH/TAMIL speaking). If the score is 4 and above and IQ above 90 and Medical fitness given by treating Oncologist to undergo Cognitive behavior therapy and or Art based therapy, the other baseline assessments – Automatic thoughts, Anxiety, Depression and Quality of life of the child will be assessed.
The eligible samples are randomly assigned by the Biostatistics department for Intervention. Random assignment of 93 children with cancer in the Intervention Arm – 1 (Cognitive Behavior Therapy - 40 minutes) and 93 children with cancer in the Intervention Arm – 2 (Cognitive Behavior and Art Based Therapy - 20 + 40 minutes with break) alternatively as per the admissions over the period of data collection. 
The CBT module is based on Aaron Beck & Judith Beck Model (derived from Beck model by the Investigator, a clinical psychologist) and Art based Therapy is based on Cathy Malchiodi techniques (helped by Art Therapist to develop the Art based therapy module ). Each child is given 6 intervention sessions lasting for 40 to 60 minutes one-to-one over a period of 1 month.
Post intervention, after a week, the Psycho-oncologist will do the post assessment of distress, Automatic thoughts, Anxiety, Depression and Quality of life. One month and 6 months post intervention a follow-up assessment is done along with focus group discussion. 
 
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