| CTRI Number |
CTRI/2024/10/074943 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Palliative Care Needs and Quality of Life in Children with Cancer |
|
Scientific Title of Study
|
Screening for Palliative Care needs and exploring its association with Quality of Life in Children with Cancer |
| 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 Vani Verma |
| Designation |
PhD Scholar |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pediatric Hematology and Oncology, Kasturba Medical College Manipal, Manipal Academy of Higher Education
Madhav Nagar, Eshwar Nagar, Manipal, Udupi.
Udupi
KARNATAKA
576104
India |
| Phone |
07760180781 |
| Fax |
|
| Email |
vani.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasudeva Bhat K |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pediatric Hematology and Oncology, Kasturba Medical College Manipal, Manipal Academy of Higher Education
Madhav Nagar, Eshwar Nagar, Manipal, Udupi.
Udupi
KARNATAKA
576104
India |
| Phone |
9619114703 |
| Fax |
|
| Email |
vasudev.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasudeva Bhat K |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pediatric Hematology and Oncology, Kasturba Medical College Manipal, Manipal Academy of Higher Education
Madhav Nagar, Eshwar Nagar, Manipal, Udupi.
Udupi
KARNATAKA
576104
India |
| Phone |
9619114703 |
| Fax |
|
| Email |
vasudev.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
Department of Pediatric Hematology and Oncology,
Kasturba Medical College, Manipal,
Manipal Academy of Higher Education,
Madhav Nagar, Eshwar Nagar, Manipal,
Udupi-district,
Karnataka,
India.
PIN-576104 |
|
|
Primary Sponsor
|
| Name |
Dr Vani Verma |
| Address |
Department of Pediatric Hematology and Oncology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Madhav Nagar, Eshwar Nagar, Manipal, Udupi |
| Type of Sponsor |
Other [Self] |
|
|
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 Vani Verma |
Kasturba Medical College |
Department of Pediatric Hematology and Oncology,
Manipal Academy of Higher Education,
Madhav Nagar, Eshwar Nagar,
Manipal,
Karnataka, India.
PIN 576104
Udupi
KARNATAKA |
7760180781
vani.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Caregivers |
| Patients |
(1) ICD-10 Condition: C81-C96||Malignant neoplasms of lymphoid, hematopoietic and related tissue, (2) ICD-10 Condition: C40-C41||Malignant neoplasms of bone and articular cartilage, (3) ICD-10 Condition: C64||Malignant neoplasm of kidney, except renal pelvis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
For Children 1. Children are diagnosed with cancer, aged 2-18 years. 2. At least one month after the cancer diagnosis. 3. Able to communicate and read in either the local language, Kannada or English. For Caregivers: 1. Primary caregivers include father and/or mother, and if parents are not available, grandparents who provide care to children with cancer for a period exceeding one month. 2. Unpaid family caregivers of children with cancer. 3. Aged 18 years or older. 4. Able to communicate and read in either the local language, Kannada or English. |
|
| ExclusionCriteria |
| Details |
For Children: 1. Children with severe cognitive impairments affecting their ability to participate in the study 2. Being unwilling to give informed consent For Caregivers: 1. Severe
cognitive impairments affecting their ability to participate in the study 2. Not being able to communicate verbally or orally 3. Being unwilling to give informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore the association of Palliative Care needs with Quality of Life in Children with Cancer. |
24-30 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. To assess the Quality of Life in children with Cancer using PedsQLTM Cancer Module 3.0.
b. To assess the Palliative Care needs in Children with Cancer using PaPaS scale.
c. To measure the Caregiver Burden using “The Caregiving Burden Scale for Family Caregivers of Children with Cancers (CBSFC-CC)†in a pediatric oncology setting |
18-24 months to assess the Quality of Life in children with Cancer using PedsQLTM Cancer Module 3.0 and to assess the Palliative Care needs in Children with Cancer using PaPaS scale.
24-30 months to measure the Caregiver Burden using “The Caregiving Burden Scale for Family Caregivers of Children with Cancers (CBSFC-CC)†in a pediatric oncology setting |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
15/10/2024 |
| 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="3"
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
|
Summary of Background & Purpose of Trial Palliative care is essential in improving the well-being of terminally ill patients in India, particularly children with cancer. Despite advancements in community programs, there is a significant shortage of specialized palliative care professionals and a high burden on caregivers, especially in low- and middle-income countries. Research indicates that palliative care enhances the quality of life for pediatric cancer patients by addressing their physical, psychosocial, and spiritual needs. However, the integration of palliative care remains low, and there is a lack of research on effective symptom management and the long-term impact of caregiving on parents. Purpose of the Trial: This trial aims to explore the association between palliative care needs and the quality of life in children with cancer. It also seeks to assess the quality of life using the PedsQLâ„¢ Cancer Module 3.0, evaluate palliative care needs with the Pediatric Palliative Screening Scale (PaPaS), and measure caregiver burden using the Caregiving Burden Scale for Family Caregivers of Children with Cancers (CBSFC-CC). The expected outcomes include a detailed assessment of quality of life, identification of areas for targeted interventions, quantification of caregiver burden, and validation of these assessment tools for future research and clinical practice.
|