| CTRI Number |
CTRI/2024/07/071204 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Profile of Behavioral problems in children with cancer other than than Brain cancers |
|
Scientific Title of Study
|
Profile of Behavioral problems in Children with Non Central Nervous System Malignancies |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MONISHA R |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Ward 19B, Department of Pediatrics, Maulana Azad Medical College and Lok Nayak Hospital
2,Bahadurshah Zafar Marg , New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9606229791 |
| Fax |
|
| Email |
monisha3.1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Mishra |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Department of Pediatrics, Maulana Azad Medical College and Lok Nayak Hospital
2,Bahadurshah Zafar Marg , New Delhi
New Delhi
DELHI
110002
India |
| Phone |
23233400 |
| Fax |
|
| Email |
drdmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devendra Mishra |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Department of Pediatrics, Maulana Azad Medical College and Lok Nayak Hospital
2,Bahadurshah Zafar Marg , New Delhi
DELHI
110002
India |
| Phone |
23233400 |
| Fax |
|
| Email |
drdmishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Lok Nayak Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
2,Bahadurshah Zafar Marg, New Delhi -02 |
| Type of Sponsor |
Government medical college |
|
|
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 R MONISHA |
Lok Nayak Hospital |
Room no 517,Pediatric Medicine OPD,Fifth Floor,OPD building,Lok Nayak Hospital,New Delhi
New Delhi
DELHI |
9606229791
monisha3.1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITAL Lok Nayak, G.I.P.M.E.R, Guru Nanak Eye Centre, New Delhi – 110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
NIL |
NIL
|
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 2 years to 12 years
2.Children started on Chemotherapy and planning to continue the same from the department of paediatrics at Lok Nayak Hospital, New Delhi. |
|
| ExclusionCriteria |
| Details |
1. children with pre existing diagnosed psychological illness
2. children with any neuromotor impairment at the time of assessment for behavioral problems |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of children developing behavioural problems within 6 weeks after diagnosis as per SDQ scale. |
Within 6 weeks after diagnosis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Number of children developing behavioural problems within 6 weeks after diagnosis as per CBCL
2.Number of children developing behavioural problems at 3 months after diagnosis as per CBCL and SDQ scale
3.Profile of behavioural problems and time interval from enrolment to onset of behavioural problems |
1.Within 6 weeks
2.Within 3 Months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2024 |
| Date of Study Completion (India) |
20/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
According to a recent National Cancer Registry Programme (NCRP) report in India, childhood cancers (0–14 year age group) accounted for 4.0% of all cancers. The age-adjusted cancer incidence rate in children is 203.1 per million in boys and 125.4 per millions in girls. Survival rate for childhood malignancies, specifically acute lymphoblastic leukemia (ALL), has improved during the past two decades with the introduction of new treatment modalities and chemotherapeutic agents. Chemotherapy for ALL has a significant impact on the psychological status of both patients and their parents, with high prevalence of low self-esteem in patients and high degree of psychological stress in their parents. Failure in school performance, restricted group activity and less social relations have been shown to be significantly higher in children with ALL. The patients have to cope up with illness, medication and its influence on their development. Consequently, large number of them have emotional disorders that influence the course and outcome of physical disorder. In a prominent hospital based study, it was found that 90%children with ALL had emotional disorders. All the disorders were mild to moderate in intensity and were perceived to be easily treatable . Children with CNS malignancies experience depression , anxiety , psychosocioal problems due to the brain tumour , chemotherapy , radiation and intrathecal methotrexate . The impact on behavioral development in children with malignancies, leads to behavioral and psychosocial problems in adulthood. There are limited studies regarding behavioral complications in children with non central nervous system malignancies. This study aims to determine the behavioural problems at an early stage followed by early intervention and treatment.
There is paucity of literature on the profile of behavioral problems in children with non-central nervous system malignancies, especially from India. This, Descriptive Cohort Study, will contribute in assessing the profile of behavioural problems in Children with Non central nervous system malignancies. |