| CTRI Number |
CTRI/2023/12/060697 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
19/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Development and exploring the effect of Paediatric Palliative Care services embedded within the Paediatric Oncology care setting
|
|
Scientific Title of Study
|
Embedded Model of Integrated Paediatric Palliative Care in Paediatric Oncology:
Development and Testing its Effectiveness. (EMANCIPATION Study)
|
| Trial Acronym |
EMANCIPATION |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naveen Salins |
| Designation |
Professor and Head of Department |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher education, Manipal |
| Address |
Department of Palliative Medicine and Supportive care, Room no 4, Manipal Comprehensive cancer care centre, Shirdi Sai Cancer Block, Kasturba Hospital, Eshwar Nagar,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922221 |
| Fax |
|
| Email |
naveensalins@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveen Salins |
| Designation |
Professor and Head of Department |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher education, Manipal |
| Address |
Department of Palliative Medicine and Supportive care, Room no 4, Manipal Comprehensive cancer care centre, Shirdi Sai Cancer Block, Kasturba Hospital, Eshwar Nagar,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922221 |
| Fax |
|
| Email |
naveensalins@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen Salins |
| Designation |
Professor and Head of Department |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher education, Manipal |
| Address |
Department of Palliative Medicine and Supportive care, Room no 4, Manipal Comprehensive cancer care centre, Shirdi Sai Cancer Block, Kasturba Hospital, Eshwar Nagar,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922221 |
| Fax |
|
| Email |
naveensalins@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research,New Delhi |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Veronique Dinand |
Bai Jerbai wadia Hospital for Children |
Acharya Donde Marg, Parel, Mumbai, 400014
Mumbai
MAHARASHTRA |
9971839244
verodinand@gmail.com |
| Dr Naveen Salins |
Kasturba Medical College and Kasturba Hospital, Manipal |
Eshwar Nagar, Manipal, 576104
Udupi
KARNATAKA |
08202922221
naveensalins@gmail.com |
| Dr Gayatri Palat |
MNJ Institute of Oncology and Regional cancer Centre |
11-5, 399red hills, Red Hills, Lakdikapul, Hyderabad 500004
Hyderabad
TELANGANA |
9985480614
gpalat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Bai Jerbai Wadia Childrens Hospital |
Approved |
| Kasturba Medical College and Kasturba Hospital, Institutional Ethics Committee |
Approved |
| MNJ Institute of Oncology and Regional Cancer Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1) All children age of 18 years and below, 2) Children diagnosed with cancer, 3)New or Follow up cases of Childhood cancer patients, 4) Children with cancer in both IPD & OPD setting.
|
|
| ExclusionCriteria |
| Details |
1) Children following up with pediatric oncology services, in cancer remission.
2) Refusal of consent from parents and assent from adolescent children. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identifying Palliative care needs in children with cancer using Paediatric Palliative Care Scale (PaPaS) screening tool. Score |
1 baseline visit (T0) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identifying the symptom burden in children with cancer at presentation to paediatric oncology |
1 baseline visit (t0) |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
31/12/2023 |
| 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
|
Annually world-wide 300,000 children are detected with cancer, 90% of them live in low and middle-income countries. Children in low-income countries have a cure rate of 30-50%. Around 4.2 million children need palliative care in India, but only small percentage of children are referred and often referred late. Palliative care in a paediatric oncology setting is known to improve pain, symptoms, quality of life and end of life support. According to the studies conducted by Brock 2021, Farooki 2021 and Falk 2021 (all USA), the embedded paediatric palliative oncology models demonstrated a higher number of children accessing palliative care, longer stay with the palliative care service before death, and fewer days in the hospital during the last three months of their lives and enabled better acceptance of paediatric palliative care by the paediatric oncologists. However, this model is never tested outside of United States and considering the dismal rate of palliative care access to children in India (<0.5%), the results of this study might influence future policy and practice. The key expected outcome is to identify the palliative care needs in children with cancer in a paediatric oncology care setting.
|