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
|
|
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
|
|
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
|
|
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. |