| CTRI Number |
CTRI/2019/07/020280 [Registered on: 19/07/2019] Trial Registered Prospectively |
| Last Modified On: |
15/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Phenomenological study |
| Study Design |
Other |
|
Public Title of Study
|
Explore live experiences of caregivers of cancer patients |
|
Scientific Title of Study
|
A phenomenological study to explore lived experiences of caregivers of cancer patients receiving palliative care at hospice, U.T. Chandigarh 2018-20 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayushi Sood |
| Designation |
M.Sc Nursing Student |
| Affiliation |
National institute of nursing education PGIMER Chandigarh |
| Address |
National institute of nursing education PGIMER Chandigarh
Room No. 208 at department NINE
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9129811264 |
| Fax |
|
| Email |
aayushisood000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti |
| Designation |
Lecturer |
| Affiliation |
PGIMER Chandigarh |
| Address |
National Institute of nursing education PGIMER Chandigarh
Nursing department NNE
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437748011 |
| Fax |
|
| Email |
shrutipgi2011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti |
| Designation |
Lecturer |
| Affiliation |
PGIMER Chandigarh |
| Address |
National Institute of nursing education PGIMER Chandigarh
Nursing department NINE
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437748011 |
| Fax |
|
| Email |
shrutipgi2011@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Administration Deapartment |
| Address |
Post graduate institute of medical education and research Chandigarh Sector 12 |
| 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 |
| Ayushi Sood |
Post graduate institute of medical education and research Chandigarh |
Room No. 5 Hospice department
Chandigarh
CHANDIGARH |
9129811264
aayushisood000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee PGIMER Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Without any mental disability |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The caregivers included who are willing to participate and can communicate in Hindi English and Punjabi and involved in routine care |
|
| ExclusionCriteria |
| Details |
Caregivers are excluded who have any cognitive dysfunctions and who are paid. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know in depth about feelings of caregivers who are involved in routine care of cancer patients |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explain the physical, emotional, financial impact of care giving on caregivers |
1 year |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
20/07/2019 |
| 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
|
This study will be published in thesis and article will be published in a good journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is conducted to explore the experiences of caregivers involved in routine care of cancer patients admitted in hospice Chandigarh for palliative care. This study will help the nurses to know in depth about the feelings of caregivers. The participants will be selected by purposive sampling technique and data will be collected through interview guide which include patient related factors, care demands, physical burden, emotional burden, financial burden, coping, future outlook. Pilot study will be done in the month of July 2019 and final data will be collected in August and September 2019. |