FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/088836 [Registered on: 13/06/2025] Trial Registered Prospectively
Last Modified On: 13/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Pediatric Education Discharge Support Services (PEDSS) on managing symptoms and complications in children with blood cancer at a specialized hospital 
Scientific Title of Study   Effectiveness of Pediatric Education Discharge Support Services (PEDSS) on management of symptoms and complications for children with Hematological cancer in a tertiary care centre 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VANITA 
Designation  Tutor/Clinical instructor 
Affiliation  All india institute of medical sciences 
Address  Tutor room no 1 , Building 45, Centre of excellence in Nursing education and research, All india institute of medical sciences, RISHIKESH

Dehradun
UTTARANCHAL
249203
India 
Phone  09555393272  
Fax    
Email  vanitakumari94@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  VANITA 
Designation  Tutor/Clinical instructor 
Affiliation  All india institute of medical sciences 
Address  Tutor room no 1 , Building 45, Centre of excellence in Nursing education and research, All india institute of medical sciences, RISHIKESH


UTTARANCHAL
249203
India 
Phone  09555393272  
Fax    
Email  vanitakumari94@gmail.com  
 
Details of Contact Person
Public Query  
Name  VANITA 
Designation  Tutor/Clinical instructor 
Affiliation  All india institute of medical sciences 
Address  Tutor room no 1 , Building 45, Centre of excellence in Nursing education and research, All india institute of medical sciences, RISHIKESH


UTTARANCHAL
249203
India 
Phone  09555393272  
Fax    
Email  vanitakumari94@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Vanita 
Address  Tutor room no 1, Building 45, Centre of Education in Nursing Education and Research, All India Institute of Medical Sciences, Rishikesh, Uttarakhand 249203  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Uttam Nath Singh  All india institute of medical sciences, RISHIKESH  Medical hematology opd, room no 4, level 3, OPD Block, AIIMS Rishikesh
Dehradun
UTTARANCHAL 		 9555393272

vanitakumari94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], (2) ICD-10 Condition: C920||Acute myeloblastic leukemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pediatric education discharge support services.  Content: Video assisted discharge education on management of symptoms and complications: Education on common symptoms such as nausea, pain, weight gain or loss, fatigue, sleep, infection prevention etc. Interactive discharge checklist: It facilitates two-way communication and participation between nurse and patient. Its interactive version allows for real-time engagement, updates, and customization based on the patients specific needs. Checklist will include questions related to medicines, follow up care, home care instructions, diet, nutrition etc. Pamphlet for child and caregiver: Bullet points for what to do and not to do during symptoms and complication emergence. Peer support group connect: Physical meeting during hospital stays and what’s app group for sharing of common problems, feelings, and emotion. Emergency contact: Telephonic reach for caregivers during emergency. Delivery: • Provided by pediatric oncology nurses trained in standardized PEDSS delivery. • Initial session at the time of first discharge post-diagnosis; reinforced during home visits or telephonic follow-up at 1- and 2-weeks post-discharge. Materials: Video, Interactive discharge checklist, Pamphlet for child and caregiver, peer support group connect and emergency contact info. Target Population: Parents/caregivers of children aged 3–17 years newly diagnosed with hematologic malignancies, discharged from hospital. Primary Aim: Improve caregiver ability to detect and manage common post-discharge symptoms and Complications at home. Outcomes: • Symptom burden (pain, nausea, fatigue, sleep, appetite) measured via validated caregiver-reported scales. • Healthcare utilization: number of unscheduled clinic visits, ER visits, readmissions. • Caregiver coping, preparedness, and satisfaction assessed via validated instruments.  
Comparator Agent  Routine discharge education  Content: A routine structured nurse-led session focusing on discharge education according to discharge summary. Delivery & Materials: • Delivered by the same trained nurses at the same timepoints (discharge, 1- and 2-week follow-up), using discharge summary. • Target Population: Same as the intervention arm for direct comparison. Primary Aim: Improve caregiver ability to detect and manage common post-discharge symptoms and Complications at home. Outcomes: • Symptom burden (pain, nausea, fatigue, sleep, appetite) measured via validated caregiver-reported scales. • Healthcare utilization: number of unscheduled clinic visits, ER visits, readmissions. • Caregiver coping, preparedness, and satisfaction assessed via validated instruments.  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Children aged 3 -18 years and diagnosed with hematological cancer
2. Parent, caregiver, legal guardian aged over 18 years of selected child.
3. Parent needed to speak Hindi or English.
4. Diagnosed at least 1 month before or within 5 years after the diagnosis., treatment initiated, admitted at least once prior.
 
 
ExclusionCriteria 
Details  1. Children with cognitive disabilities.
2. Parent, legal guardian, or caregiver who is having any psychiatric illness.
3. Children, parent, legal guardian, or caregiver who are not willing to participate in study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluate the effectiveness of PEDSS on management of symptoms and complications at home for children with hematological cancer.  1. At discharge
2. 1 months from discharge
3. 2 months from discharge 
 
Secondary Outcome  
Outcome  TimePoints 
1. To explore the problems faced by children and parents at home related to management of symptoms and complications for children with hematological cancer.
2. Development and validation of Paediatric Education Discharge Support Services (PEDSS) for children with hematological cancer.
3. Compare PEDSS with standard discharge teaching on management of symptoms and complications at home for children with hematological cancer.
4. To assess the parental perception and feasibility of PEDSS for children with hematological cancer.
 		 1. At discharge
2. 1 months from discharge
3. 2 months from discharge 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/08/2025 
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="0"
Months="9"
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 randomized controlled trial at AIIMS Rishikesh will assess the effectiveness of Pediatric Education Discharge Support Services (PEDSS) in managing symptoms and complications in children with hematological cancer.

Study Design

Approach: Quantitative

Setting: Hemat-oncology clinic & pediatric hematology ward

Population: Children (3-18 years) with hematological cancer & their parents

Sample: 100 participants (50 control, 50 experimental)

Sampling: Convenient sampling with random allocation

Blinding: Statistician blinded

Variables

Independent: PEDSS

Dependent: Symptom management, unplanned service use, parental perception & satisfaction

Extraneous: Demographic & clinical factors

Eligibility Criteria

Inclusion: 

1. Newly diagnosed children (3-18 years) & their parents who speak Hindi/English.
Exclusion: 

1. Children with cognitive disabilities, parents with psychiatric illness, unwilling participants

Intervention (PEDSS)

A nurse-led education program to improve home management:

  1. Video education on symptom management (nausea, pain, fatigue, infections, etc.)
  2. Interactive checklist for medication, follow-up, home care, nutrition
  3. Pamphlets with simple instructions & visuals
  4. Peer support group (in-person & WhatsApp)
  5. Emergency contact support for caregivers

Implementation

Teaching strategies: Video, discussions, teach-back method, role modeling

Validation: By experts in pediatric nursing, oncology, and nutrition

Training process: Informal discussions, interactive demonstrations, correction & reteaching as needed

Emergency support: Telephonic assistance for urgent queries

 
Close