| CTRI Number |
CTRI/2023/09/057755 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
15/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
Psychosocial Impact of Childhood Cancer on the Siblings of Childhood Cancer Survivors |
|
Scientific Title of Study
|
Hidden Cost of Pediatric Cancer: Effect of Childhood Cancer on Siblings Psychological Well-being |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishesh Jain |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
4007 Pediatric Surgery AIIMS New Delhi
DELHI
110029
India
DELHI
110029
India |
| Phone |
8860080432 |
| Fax |
|
| Email |
dr.vishesh79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishesh Jain |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
4007 Pediatric Surgery AIIMS New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
8860080432 |
| Fax |
|
| Email |
dr.vishesh79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishesh Jain |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
4007 Pediatric Surgery AIIMS New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
8860080432 |
| Fax |
|
| Email |
dr.vishesh79@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Vishesh Jain |
| Address |
4007 Pediatric Surgery AIIMS New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Vishesh Jain |
All India Institute of Medical Science |
7th floor, Mother and Child block, AIIMS, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI |
8860080432
dr.vishesh79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Siblings of children currently dealing with cancer |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Siblings of children with extracranial solid tumor who have been diagnosed with tumor and are undergoing treatment for at least three months
2. Sibling must have been born prior to the time cancer was diagnosed in their brother or sister
3. Siblings who have been living with the patient continuously since the diagnosis of the tumor
4. Siblings who do not have any chronic medical or neurological disease
|
|
| ExclusionCriteria |
| Details |
1. Siblings who were sent to live with relatives or were sent to boarding school after the diagnosis of the tumor
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Detailed assessment of self-concept, resilience, coping, & emotional intelligence of siblings of children currently dealing with cancer. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any association between experiences of siblings of children currently dealing with cancer with their self-concept, resilience, coping, & emotional intelligence. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/09/2023 |
| 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
|
Research has shown that cancer has psycho-social impacts not only on cancer patients but also on their family members. Moreover, numerous studies have been conducted on the role of primary caregivers and the experiences of providing care. However, because siblings’ significance in caregiving is recognised much less than the parent-child relationship, there is an even limited understanding of what siblings’ experiences are. The purpose of this study is to thus assess the emotional intelligence, resilience, self-concept and coping of siblings of children currently dealing with cancer. |