| CTRI Number |
CTRI/2024/06/069673 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Family Views and Coping with Caregiver Burden in Cancer Care |
|
Scientific Title of Study
|
A study to assess the family perception regarding End of life care and caregiver burden in terminally ill with oncological illness at Tertiary Hospital AIIMS New Delhi |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NiL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya saikia |
| Designation |
Msc Nursing Student |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Porta Cabin 2, first floor
College Of Nursing,
AIIMS New Delhi, southwest
Porta Cabin 2, first floor
College Of Nursing,
AIIMS New Delhi, southwest
New Delhi
DELHI
110029
India |
| Phone |
8402020822 |
| Fax |
|
| Email |
priyasaikia55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priya saikia |
| Designation |
Msc Nursing Student |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Porta Cabin 2, first floor
College Of Nursing
AIIMS New Delhi, southwest
Porta Cabin 2, first floor
College Of Nursing
AIIMS New Delhi, southwest
New Delhi
DELHI
110029
India |
| Phone |
8402020822 |
| Fax |
|
| Email |
priyasaikia55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Ujjwal Dahiya |
| Designation |
Associate Professor |
| Affiliation |
All India Istitute of Medical Sciences, New Delhi |
| Address |
Room no- 3, first floor
College of Nursing, southwest
AIIMS New Delhi
Room no- 3, first floor
College of Nursing, southwest
AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9899770134 |
| Fax |
|
| Email |
ujjwaldahiya3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.B.R.A-IRCH, Room no-9, first floor Palliative unit department,
Pin- 110029
AIIMS New Delhi |
|
|
Primary Sponsor
|
| Name |
college of nursing AIIMS NEW DELHI |
| Address |
Porta cabin room no -2
first floor
College Of Nursing
AIIMS New Delhi
Pin- 110029
Ansari Nagar, |
| 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 Nishkarsh Gupta |
All india institute of medical sciences, new delhi |
Dr. BRA,IRCH block
Palliative unit department
room no- 9, first floor
south west , delhi
New Delhi
DELHI |
9013310014
drnishkarshgupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Who are terminally ill and survival chance are for 1 year.
family member- who are primary caregiver, can read and write and give consent to participate. |
|
| ExclusionCriteria |
| Details |
patient- lack primary caregiver
family member- illiterate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess family perception and caregiver burden regarding end-of-life care. |
T1- BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find an association between selected demographic & perception of families regrading end-of-life care.
To find an association between selected demographic & caregiver burden regarding end-of-life care. |
After 3 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/08/2024 |
| 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="25"
Months="2"
Days="28" |
|
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
|
’ A study to assess family perception regarding end-of-life care and caregiver burden in terminally ill patient with oncological illness at tertiary hospital, AIIMS New Delhi’
primary objectives-
1. to assess the family perception regarding end-of-life care
2. to assess the care giver burden regarding end-of-life care. secondary objectives-
1. to find an association between selective demographic data and perception regarding end-of-life care. 2. to find an association between selective demographic data and care giver burden regrading end-of-life care. So this study is taken up because according to WHO - Cancer is a leading cause of death for nearly 10 million deaths worldwide , increasing prevalence of cancer among adults the caregiver burden is gradually increasing which has led to the growing interest in improving the quality of end-of-life care for people and till date there is limited reported research evaluating end-of-life care from the perspective of family members.whereas in India end-of life care is a new concept which is often mistaken or misunderstood as a supportive care& there is limited studies are available to address the issues and understand the concept of it .
|