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CTRI Number  CTRI/2025/05/087368 [Registered on: 22/05/2025] Trial Registered Prospectively
Last Modified On: 21/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Psycho-social Problems and the Mental Wellbeing of Childhood Cancer Survivors and Healthy children: A Cross-Sectional Comparative study from a Tertiary Cancer Centre.  
Scientific Title of Study   Psycho-social Problems and the Mental Wellbeing of Childhood Cancer Survivors and Healthy children: A Cross-Sectional Comparative study from a Tertiary Cancer Centre.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jisha Abraham 
Designation  Lecturer, Psycho-oncology  
Affiliation  Malabar Cancer Centre  
Address  Malabar Cancer Centre (Post Graduate Institute of Oncology Sciences & Research), Moozhikkara (P.O), Thalassery, Kannur District, Kerala, India-670103

Kannur
KERALA
670103
India 
Phone  04902399268  
Fax    
Email  maria2201chacko@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jisha Abraham 
Designation  Lecturer, Psycho-oncology  
Affiliation  Malabar Cancer Centre  
Address  Malabar Cancer Centre (Post Graduate Institute of Oncology Sciences & Research), Moozhikkara (P.O), Thalassery, Kannur District, Kerala,India-670103

Kannur
KERALA
670103
India 
Phone  04902399268  
Fax    
Email  maria2201chacko@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Maria Puthumana Chacko 
Designation  Fellow in Oncology Social Work  
Affiliation  Malabar Cancer Centre  
Address  Malabar Cancer Centre (Post Graduate Institute of Oncology Sciences & Research), Moozhikkara (P.O), Thalassery, Kannur District, Kerala,India-670103

Kannur
KERALA
670103
India 
Phone  9748853557  
Fax    
Email  maria2201chacko@gmail.com  
 
Source of Monetary or Material Support  
Malabar Cancer Centre, Thalassery, Kannur, Kerala  
 
Primary Sponsor  
Name  Malabar Cancer Centre  
Address  Malabar Cancer Centre, Thalassery, Kannur Kerala  
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 
Jisha Abraham   Malabar Cancer Centre   Division of Psycho-oncology, Malabar Cancer Centre, Kannur, Kerala Kannur KERALA
Kannur
KERALA 
04902399268

jishasarah@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee, Malabar Cancer Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy children of the age group 11 - 17 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Inclusion Criteria for Survivors:
1.Childhood cancer survivors currently in the age group of 11 years and 17 years.
2.Survivors must have completed 6 months after their treatment from Malabar Cancer Centre.
3.At least one parent is alive and is staying with the survivor.
4.Survivors and legal guardian who can read, write, and understand Malayalam or English.

Inclusion Criteria for Healthy children:
1.Children in the age group of 11 years and 17 years.
2.At least one parent is alive and is staying with the child.
3.Children and legal guardian who can read, write and understand English or Malayalam.
 
 
ExclusionCriteria 
Details  Exclusion Criteria:
1.Survivors and healthy children with history of any known psychiatric or psychological conditions or psycho-social interventions.
2.Survivors and healthy children with a known history of sensory impairment or congenital physical disabilities or Intellectual Disability or cardiac or neurological diseases.
3.Survivors who have been diagnosed with brain tumours.
4.Survivors who have underwent Stem cell transplant treatment.
5.Survivors with relapse/recurrence/second primary at follow up.
6.Healthy children with known comorbidities or history of other health conditions.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To find the prevalence of psycho-social problems and mental wellbeing among childhood cancer survivors.   NA  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the psycho-social problems and mental wellbeing of the childhood cancer survivors and the healthy children.   Baseline  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   02/06/2025 
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="6"
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  

The research protocol examines the psycho-social problems and mental wellbeing of childhood cancer survivors compared to healthy children, using a cross-sectional comparative study at the Malabar Cancer Centre, Kerala.

Advances in medical science have improved childhood cancer survival rates, but survivors often face significant psycho-social challenges due to long-term physical, emotional, and cognitive effects of treatment. Existing studies indicate higher rates of depression, anxiety, and social difficulties among survivors compared to their healthy peers, though data from India remains sparse. This research seeks to bridge this gap by exploring these issues and identifying targeted interventions.

The study’s primary goal is to assess the prevalence of psycho-social problems and mental wellbeing among childhood cancer survivors. Secondary objectives include comparing these aspects between survivors and healthy children, analysing relationships between psycho-social problems and mental wellbeing, and exploring how survivor-related factors influence these outcomes.

The study uses a comparative cross-sectional design, enrolling 60 childhood cancer survivors aged 11-17 and an equal number of healthy children matched by age and demographics. Purposive sampling will be employed, with inclusion criteria ensuring that participants are free of psychiatric conditions and other health complications. The survivors must be six months post-treatment, and data will be collected using validated tools like the Strengths and Difficulties Questionnaire (SDQ) and the WHO-5 Wellbeing Index. Data collection is scheduled for December 2024 to June 2025.

The SDQ assesses emotional, behavioural, and social domains, while the WHO-5 evaluates mental wellbeing. Both tools are available in English and Malayalam, ensuring accessibility. Data will be statistically analysed using SPSS software. The study ensures ethical compliance, with approvals from institutional committees and informed consent from participants and guardians. Participant confidentiality is maintained, and any identified psychological needs will lead to referrals without disrupting the study.

This research could inform psycho-social support strategies for childhood cancer survivors in India, highlighting the importance of addressing emotional and behavioural health alongside physical recovery. Findings will be disseminated through academic publications and conferences.

The study underscores the critical need for comprehensive survivor care, emphasizing holistic approaches that promote long-term wellbeing.

 
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