| CTRI Number |
CTRI/2025/05/086745 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating The Impact Of Parent Child Integrated Palliative Care Model On Parental Well Being And Paediatrics Cancer Patient Outcome |
|
Scientific Title of Study
|
A Study To Assess Effectiveness Of Parent Child Integrated Palliative Care Model On Parental Quality Of Life, Symptom Burden And Quality Of Life Among Pediatrics Cancer Patients In AIIMS DELHI . |
| Trial Acronym |
N/A |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavita Yadav |
| Designation |
MSc nursing student |
| Affiliation |
|
| Address |
Porta cabin- 2 college of nursing ,All India Institute of Medical sciences
South
DELHI
110029
India |
| Phone |
7018227591 |
| Fax |
|
| Email |
ky8547000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ujjwal Dahiya |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical sciences |
| Address |
Room no. 3, 2nd floor ,college of nursing ,All India Institute of Medical sciences
South
DELHI
110029
India |
| Phone |
9899770134 |
| Fax |
|
| Email |
ujjwaldahiya3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ujjwal Dahiya |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical sciences |
| Address |
room no. 3, 2nd floor ,College of nursing, All India Institute of Medical Sciences
South
DELHI
110029
India |
| Phone |
9899770134 |
| Fax |
|
| Email |
ujjwaldahiya3@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Nursing All India Institute Of Medical Sciences New Delhi India 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences New Delhi |
| Address |
Porta Cabin -2,College of Nursing All India Institute Of Medical Sciences New Delhi |
| 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 Ujjwal Dahiya |
All India Institute Of Medical Sciences New Delhi |
IRCH Room no 4 Medical Oncology OPD GROUND FLOOR ,All India Institute Of Medical Sciences New Delhi
South
DELHI |
9899770134
ujjwaldahiya3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH , ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI 11OO29 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C801||Malignant (primary) neoplasm, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
booklet of parent child integrated palliative care model |
relaxation technique , yoga therapy , cancer narration |
| Comparator Agent |
standardized care only |
standardized care |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Pediatric patient diagnosed with cancer.
2. Have advanced cancer, at least 2 week history of progressive, recurrent or non responsive cancer of any type or any brain stem tumor or grade 4 cancer or decision not to pursue further cancer directed therapy. Patient undergoing palliative care or in need of symptom management.
3. parental consent, assent for participation in the study.
4. Patient who can communicate their symptoms.
5. Willingness of both the patient and family to participate in the study.
6. For eligible parents, one of the parents with cancer patients.
7. For eligible parents able to communicate. |
|
| ExclusionCriteria |
| Details |
1.Children with non-malignant diseases.
2.Children less than 2 years
3.Patients or parents with severe cognitive or developmental impairments that would prevent the collection of reliable data on symptom burden or quality of life.
4.Children whose family members are unable to participate in the study due to language barriers or other logistical reasons.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To reduce symptom burden among paediatric cancer patients .
2.To improve quality of life among paediatrics cancer patients .
3.To improve parental quality of life |
10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. to determine relationship between symptom burden and quality of life among paediatric cancer patients .
2. To find out association of parental quality of life ,symptom burden and quality of life among paediatric cancer patients with selected variables including demographic and clinical variables .
3. To evaluate the user level of satisfaction with "PCIPCM" among intervention group |
10 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
29/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/12/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A RCT is conducted with the aim to improve parental quality of life , reduce symptom burden and improve quality of life among paediatrics cancer patients receiving parent child integrated palliative care model .Sample population for the study is solid tumour patients age between 5-18 years receiving treatment at IRCH ,AIIMS DELHI .Sampling technique is consecutive sampling with random allocation by computer generated random numbers. Data will be collected by administering demographic datasheet to collect demographic data then assess the symptom burden through memorial symptom assessment scale and quality of life assess through paediatric quality of life scale and parental quality of assess through famiy impact core module . Data will be analysed through descriptive and inferential statistics |