| CTRI Number |
CTRI/2021/04/033117 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
25/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Patterns of End of Life Care in Cancer children |
|
Scientific Title of Study
|
Patterns of End of Life Care in Children with Cancer in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Latha M S |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pediatrics
Division of Pediatric Hemato Oncology
E1, Udayar Block
Sri Ramachandra Hospital
No.1, Ramachandra Nagar
Porur
chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
09952579525 |
| Fax |
|
| Email |
drmslatha@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Latha M S |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pediatrics
Division of Pediatric Hemato Oncology
E1, Udayar block
Sri Ramachandra Hospital
No.1, Ramachandra Nagar
Porur
chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
09952579525 |
| Fax |
|
| Email |
drmslatha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Latha M S |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pediatircs
Division of Pediatric Hemato Oncology
Sri Ramachandra Hospital
No.1, Ramachandra Nagar
Porur
chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
09952579525 |
| Fax |
|
| Email |
drmslatha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr Latha M.S. |
| Sri Ramachandra Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Latha MS |
| Address |
No.1, Ramachandra Nagar
Porur
Chennai |
| Type of Sponsor |
Other [] |
|
|
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 Latha MS |
Sri Ramachandra Hospital |
Department of Pediatrics
Division of Pediatric Hematology and Oncology
E1, Udayar Block
No.1, Ramachandra Nagar
Porur
Chennai
Chennai
TAMIL NADU |
09952579525
drmslatha@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional ethics committee |
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 |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All children with oncological diagnosis on palliative care |
|
| ExclusionCriteria |
| Details |
children with oncological diagnosis on curative intent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| describe the pattern of care of children with poor prognostic cancers who die at hospital |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to describe how the patterns of care vary by type of healthcare facility |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
03/05/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All children with oncological diagnosis, declared to be on palliative care and admitted in hospital for the end of life care would be included in the study |