| CTRI Number |
CTRI/2025/07/091756 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational therapy ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Fun Therapeutic Activities Boost thinking skills and Life Skills in Kids with Cancer |
|
Scientific Title of Study
|
Effectiveness of an Activity based Cognitive Intervention on cognitive function and occupational participation in children with cancer.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
THANGAPUSHPAM K |
| Designation |
Post graduate student |
| Affiliation |
KMCH COLLEGE OF OCCUPATIONAL THERAPY |
| Address |
KMCH College of Occupational therapy, SF No. 259,267, Kalapatti post, Coimbatore - 641048.
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9489378812 |
| Fax |
|
| Email |
pushpa10296692@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sujata Missal |
| Designation |
Director of KMCH College of Occupational therapy. |
| Affiliation |
KMCH COLLEGE OF OCCUPATIONAL THERAPY |
| Address |
KMCH College of Occupational therapy, SF No. 259,267, Kalapatti post, Coimbatore - 641048.
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9894167948 |
| Fax |
|
| Email |
sujatamissal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
THANGAPUSHPAM K |
| Designation |
Post graduate student |
| Affiliation |
KMCH COLLEGE OF OCCUPATIONAL THERAPY |
| Address |
KMCH College of Occupational therapy, SF No. 259,267, Kalapatti post, Coimbatore - 641048.
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9489378812 |
| Fax |
|
| Email |
pushpa10296692@gmail.com |
|
|
Source of Monetary or Material Support
|
| KMCH College of Occupational therapy. |
|
|
Primary Sponsor
|
| Name |
Dr Sujata Missal |
| Address |
KMCH College of Occupational therapy, No. 259,267, Kalapatti post, Coimbatore - 641048. |
| 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 Sujata Missal |
Kovai Medical Center and hospital |
Room no. 003, Ground floor, No.99, Avinashi Road, peelamedu- pudur main road,civil aerodrome post, Coimbatore- 641014
Coimbatore
TAMIL NADU |
9894167948
sujatamissal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical Committee KMCH Institute of Allied health sceinces |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], (2) ICD-10 Condition: C920||Acute myeloblastic leukemia, (3) ICD-10 Condition: C642||Malignant neoplasm of left kidney,except renal pelvis, (4) ICD-10 Condition: C844||Peripheral T-cell lymphoma, not classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Activity based cognitive intervention |
Occupational therapy play activities and games will be given as intervention to improve cognitive function in children with cancer.
Duration 5 weeks. |
| Comparator Agent |
Computerized cognitive training |
Application based cognitive interventions will be given to children in tablets to improvebtheir cognitive function. Duration 5 weeks. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with cancer
Medically stable
Age 6 to 12 years
Male, female
Having Score between 11 to 30 in Modified Child Mini Mental Status Examination MMSE
Treatment phase maintenance therapy
Cancer survivors
Both normal school going and special school going children
Treatment type allopathy alone. |
|
| ExclusionCriteria |
| Details |
Children in palliative care
Children with mental,developmental disability
Children with brain tumours |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved cognitive function in children with cancer. The expected outcome is improved scores in the Dynamic occupational therapy cognitive assessment scores after the intervention. |
5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved Occupational participation in children with cancer. Increase in the scores of Child Engagement in Daily Life Measure Version 2 after intervention. |
Baseline, after 5 weeks. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/08/2025 |
| 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="18" |
|
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
|
This project is about helping children who have had a cancer improve their cognitive function, occupational participation. All children in this study will receive cognitive retraining. One group (Control) will receive computerized cognitive training, while another group (Experimental) will receive an activity based cognitive intervention. At the end of study, both groups will be compared to see the effectiveness of activity based cognitive intervention on cognitive function and occupational participation. |