| CTRI Number |
CTRI/2025/07/090800 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Process of Care Changes
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Testing a Palliative and Supportive Care Program for Children with Cancer to Improve Their Comfort and Quality of Life |
|
Scientific Title of Study
|
Embedded Model of Integrated Paediatric Palliative Care in Paediatric Oncology:
Development and Testing its Effectiveness. (EMANCIPATION Study) |
| Trial Acronym |
NIL |
|
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 University |
| Address |
Department of Palliative Medicine and supportive care,Room no. 4 Kasturba Medical College, Manipal, Manipal Academy of Higher
education, 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 University |
| Address |
Department of Palliative Medicine and Supportive care, Room no. 4, Kasturba Medical College, Manipal, Manipal Academy of Higher
education, 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 University |
| Address |
Department of Palliative Medicine and Supportive Care, Room no. 4, Kasturba Medical College, Manipal, Manipal Academy of Higher Education
education, 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 |
Department of Palliative and supportive care, room no.1 Acharya Donde Marg,
Parel, Mumbai, 400014
Mumbai
Mumbai
MAHARASHTRA |
9971839244
verodinand@gmail.com |
| Dr Naveen Salins |
Kasturba Medical College and Kasturba Hospital, Manipal |
Department of Palliative Medicine and supportive care,Room no. 4 Kasturba Medical College, Manipal, Manipal Academy of Higher
576104
Udupi
KARNATAKA |
08202922221
naveensalins@gmail.co m |
| Dr Gayatri Palat |
MNJ Institute of Oncology and Regional cancer Centre |
Department of Pain and Palliative, Room no. 34, MNJ cancer hospital op buiding,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 |
| Institutional Ethics Committee 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 |
Paediatric specific palliative care model |
A structured pediatric palliative care model embedded into oncology workflows delivered by a palliative nurse and psychologist in coordination with the oncology team. It includes assessments using PQ-MSAS and PedsQL 3.0 at baseline 4 weeks and 8 weeks with tailored symptom and psychosocial interventions provided
Duration 1 month intervention phase as part of a 6 week monitored period |
| Comparator Agent |
Standard Pediatric Oncology Care |
Standard pediatric oncology care without structured palliative care integration or assessments.
Duration 2 month baseline period preintervention, with follow up continuing post intervention for outcome comparison.
Total duration 6 months, 2 months baseline + 1 month intervention + 2 months follow-up with data collection at 3 time points |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Intervention Group 1 Children aged 2 to 18 years with cancer 2 Receiving care at participating hospitals 3 Eligible for palliative care as per treating team 4 Primary caregiver willing to consent and participate 5 Able to complete assessments at baseline 4 and 8 weeks Comparator Group 1 Children aged 2-18 years with cancer 2 Receiving routine oncology care without palliative care 3 Caregiver willing to participate and complete follow up |
|
| ExclusionCriteria |
| Details |
Intervention Group 1. Severe cognitive or developmental issues 2. Expected survival less then 4 weeks 3. Language barriers preventing tool use 4. Caregiver unwilling to consent or follow-up. 1. Already receiving structured palliative care 2. Cognitive limitations 3. Language or logistical barriers 4. Caregiver not consenting or non-adherent to follow-up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasibility and preliminary impact of a structured pediatric palliative care intervention on symptom burden and health-related quality of life in children with cancer |
Outcomes will be assessed at three time points baseline preintervention 4 weeks mid intervention and 8 weeks post intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
04/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
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 sub-study WP9 aims to
evaluate the feasibility and preliminary impact of integrating a structured
pediatric palliative care intervention into routine oncology care for children
with cancer. Using a non randomized controlled design with an interrupted time
series approach, the study compares standard oncology care with an intervention
comprising symptom management by a palliative nurse psychosocial support by a
psychologist and use of validated assessment tools PQ MSAS and PedsQL 3.0 at
baseline 4 weeks and 8 weeks. |