| CTRI Number |
CTRI/2025/12/099732 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Psychosocial Intervention] |
| Study Design |
Other |
|
Public Title of Study
|
A support program to help care givers of children with cancer to feel and live better |
|
Scientific Title of Study
|
Effectiveness of Psychosocial Intervention Package on Psychological Problems and Quality of Life of Primary Care Givers of Children with Cancer in a Selected Hospitals at Mangalore,
India. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| YEC2/2025/164 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SrJubymol C John |
| Designation |
PhD Scholar |
| Affiliation |
|
| Address |
Yenepoya Nursing College Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8762601908 |
| Fax |
|
| Email |
sranjanarosesd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SrJubymol C John |
| Designation |
PhD Scholar |
| Affiliation |
|
| Address |
Yenepoya Nursing College Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8762601908 |
| Fax |
|
| Email |
sranjanarosesd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SrJubymol C John |
| Designation |
PhD Scholar |
| Affiliation |
|
| Address |
Yenepoya Nursing College Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8762601908 |
| Fax |
|
| Email |
sranjanarosesd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Study sites are Zulekha Yenepoya Institute of Oncology, Yenepoya Medical College Hospital Deralakatte Mangalore 575018 |
|
|
Primary Sponsor
|
| Name |
Sr Jubymol C John |
| Address |
FatherMuller College of NUrsing Kankanady Mangalore |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
FatherMuller College of NUrsing Kankanady Mangalore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Binsha Pappachan C |
Zulekha Yenepoya Institute of Oncology and Yenepoya Medical College Hospital |
Yenepoya Medical College Deralakatte Mangaluru 575018
Dakshina Kannada
KARNATAKA |
996434078
binshadennis@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Psychosocial Intervention |
face-to-face interaction teaching telephonic interactions relaxation techniques and printed
informational material which will be delivered to primary care givers of children with cancer during a specific period of time |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Primary caregivers between 18-65 years
Caregiver of a child (0–18 years) with a confirmed diagnosis of cancer
Able to understand and communicate English, Kannada and Malayalam
Able to access WhatsApp message/information
Willing and able to provide written informed consent and to attend intervention sessions and follow-up assessments |
|
| ExclusionCriteria |
| Details |
Caregivers diagnosed with severe mental health disorders
Hearing/Visual Impairment
Caregivers who decline to participate in in-depth interviews |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Standardized tools like Beck Anxiety Scale Kingston Caregiver Stress Scale Zarit burden scale Multidimensional Scale of Perceived Social Support and WHO QOL - BREF scale will be administered to assess the psychological problems such as anxiety caregiver burden caregiver stress perceived social support and quality of life.The intervention’s effectiveness will be evaluated by 15th day 3rd month and 6th month with the same tool used in the pretest |
15th day 3rd month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Standardized tools like Beck Anxiety Scale Kingston Caregiver Stress Scale Zarit burden scale Multidimensional Scale of Perceived Social Support and WHO QOL - BREF scale will be administered to assess the psychological problems such as anxiety caregiver burden caregiver stress perceived social support and quality of life.The intervention’s effectiveness will be evaluated by 15th day 3rd month and 6th month with the same tool used in the pretest |
15th day 3rd month and 6th month |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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)
|
06/01/2026 |
| 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
|
This study is a mixed methods study to evaluate the effectiveness of psychosocial intervention package on psychological problems and quality of life of primary caregivers of children with cancer. The study will explore the psychosocial problems and quality of life of primary caregivers of children with cancer. It will be conducted in Zulekha Yenepoya Institute of Oncology and Yenepoya Medical College Hospital. Standardized tools like Beck Anxiety Scale Kingston Caregiver Stress Scale Zarit burden scale Multidimensional Scale of Perceived Social Support and WHO QOL BREF scale which will be administered to assess the psychological problems such as anxiety caregiver burden caregiver stress perceived social support and quality of life. The primary outcome measures will be calculated by using the intervention’s effectiveness which will be evaluated by the above mentioned scales applied at 15th day 3rd month and 6th month. . . |