| CTRI Number |
CTRI/2026/03/106141 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Designing a Mobile App to Provide Information and Support for Families of Children in Palliative Care. |
|
Scientific Title of Study
|
Developing a Mobile Application to Provide Comprehensive Information and Support
for Families Navigating Pediatric Palliative Care. |
| 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 Shamali Poojary |
| Designation |
Assistant Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Palliative Medicine, Room no. 75, Main Building, Tata Memorial Hospital, Parel, Mumbai.
Tata Memorial Hospital, Dr. E. Borges road, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224174271 |
| Fax |
02224174271 |
| Email |
shamalipoojary8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shamali Poojary |
| Designation |
Assistant Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Palliative Medicine, Room no. 75, Main Building, Tata Memorial Hospital, Parel, Mumbai.
Tata Memorial Hospital, Dr. E. Borges road, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224174271 |
| Fax |
02224174271 |
| Email |
shamalipoojary8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shamali Poojary |
| Designation |
Assistant Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Palliative Medicine, Room no. 75, Main Building, Tata Memorial Hospital, Parel, Mumbai.
Tata Memorial Hospital, Dr. E. Borges road, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224174271 |
| Fax |
02224174271 |
| Email |
shamalipoojary8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr. E. Borges road, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, Dr. E. Borges road Parel, Mumbai- 400012. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shamali Poojary |
Tata Memorial Hospital |
Department of Palliative Medicine, Room no. 75, Main Building, Tata Memorial Hospital, Parel, Mumbai.
Tata Memorial Hospital, Dr. E. Borges road, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA |
02224174271
shamalipoojary8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - II ,Tata Memorial Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z515||Encounter for palliative care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Pediatric Palliative Care Support App |
Development and pilot testing of a mobile app to enhance communication and support for pediatric palliative care.
The frequency and duration of an intervention will be bi-weekly for 2 months. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Stage 1: Inclusion Criteria
1.Pediatric oncologists, pediatrician and PPC team members willing to participate
2.Parent of children or children with advanced cancer able to read and understand the appropriate language (English/Hindi)
Stage 2 : Inclusion Criteria
1.Patient diagnosed with advanced malignancy.
2.Patients Referred to Pediatric Palliative Care (PPC)
3.Age up to 18 years of age.
4.Access to smartphone and internet
|
|
| ExclusionCriteria |
| Details |
Stage 1 and 2 Exclusion Criteria
1.Not willing to participate.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of phone follow-ups or teleconsultations done by PPC team within 24/72 hours of the child filling the assessment form measured by descriptive statistics |
Within 24/72 hours of the child filling the assessment form |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Determine the number of Children who filled out the symptom assessment form measured by descriptive statistics. |
Time Point 1: Initial assessment (when the first form is filled out).
Time Point 2: 1 month after pilot launch (during the 2-month testing phase).
Time Point 3: 2 months after pilot launch (end of pilot phase). |
| 2.To analyze the number of times the symptom assessment forms have been filled. |
Time Point 1: First form submission (baseline).
Time Point 2: 1 month after pilot testing begins (to monitor ongoing form completions).
Time Point 3: 2 months after pilot testing begins (final number of forms completed by the end of the pilot phase). |
| 3.To Monitor Emergency Contact call trends. |
Bi-weekly for 2 months after app use begins. |
| 4.To track engagement with educational Materials. |
Time point 1 : Immediately after the educational content is made available on the app.
Time point 2 : 1 month after pilot testing begins (measuring continued engagement)
Time Point 3 :2 months after pilot testing begins( final measure of engagement during the 2 month period) |
| 5.Number of Children who filled out the symptom assessment form. |
End of 2 months after enrollment. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
09/06/2026 |
| 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 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
|
At Tata Memorial Hospital (TMH), we offer a range of Pediatric Palliative Care (PPC) services, including outpatient clinics, in-patient consultations, home-based care, and respite care. These services are designed to help children with cancer and their families manage symptoms and provide support. However, many children come from far-off places and cannot easily return to TMH for ongoing care. This makes it difficult to maintain effective communication and support once they return home. To address this challenge, we are developing a mobile application to assist families of children with advanced cancer. This app will allow parents and children to easily report symptoms, follow up with medical experts, and access peer support. By making it easier to communicate their needs and manage their care, the app aims to improve the quality of life for these children and their families, even when they are far from the hospital.
Our Project will be conducted in two stages - Stage 1: We will gather input from stakeholders—including children, parents, and healthcare professionals—about what features the app should include. This feedback will help us design the app to meet users’ needs.
Stage 2: A software developer will create the app based on the finalized content. We will pilot test the app with 10 children from Mumbai, assessing its ease of use and effectiveness in providing timely help and support.
Expected Outcomes
We hope the app will: - Improve communication between the PPC team and families.
- Enhance symptom management and support.
- Increase engagement with educational resources.
The app will help ensure that children who need intensive symptom management can receive timely care and support from their medical team, even from a distance. All data will be handled with strict confidentiality, and personal information will be securely stored and anonymized. This innovative approach aims to empower families and improve the quality of palliative care for children with advanced cancer, making it easier for them to stay connected and supported, no matter where they are. |