| CTRI Number |
CTRI/2017/12/010971 [Registered on: 26/12/2017] Trial Registered Prospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the experiences of adult family caregivers caring for patients with wounds caused by head and neck cancer in India |
|
Scientific Title of Study
|
Exploring the lived experiences of the adult family caregivers caring for patients with malignant fungating wounds in head and neck cancer in India: An Interpretative Phenomenological Analysis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naveen Salins |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Palliative Medicine
Dr. Ernest Borges Road
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
naveensalins@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Rao |
| Designation |
Senior Medical Officer |
| Affiliation |
Tata Memorial Hospital |
| Address |
Palliative Respite Care Facility
Department of Palliative Medicine
Dr. Ernest Borges Road
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
uskpsy69@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Rao |
| Designation |
Senior Medical Officer |
| Affiliation |
Tata Memorial Hospital |
| Address |
Palliative Respite Care Facility
Department of Palliative Medicine
Dr. Ernest Borges Road
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
uskpsy69@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr. Ernest Borges Road
Parel
Mumbai-400012 |
| 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 Naveen Salins |
Tata Memorial Hospital |
Room No;75, Main Building
Department of Palliative Medicine
Dr. Ernest Borges Road
Parel
Mumbai
Mumbai
MAHARASHTRA |
9969683669
naveensalins@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adult family caregivers caring for patients with malignant fungating wounds |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate in the study
Able to speak Hindi, Marathi and English
Family caregivers caring for patients with malignant fungating wounds in head and neck cancer for 3 months or more |
|
| ExclusionCriteria |
| Details |
Unable or unwilling to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To record the experiences of adult family caregivers as interview transcripts
To develop codes and themes from the interview transcripts
|
May 31, 2018 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the quality of the study |
August 31, 2018 |
|
|
Target Sample Size
|
Total Sample Size="8"
Sample Size from India="8"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="8" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2018 |
| Date of Study Completion (India) |
30/06/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a qualitative study using interpretative phenomenological analysis methodology that aims to explore the lived experiences of adult family caregivers caring for patients with malignant fungating wounds in head and neck cancer in India. The study aims to recruit 8 patients and study their experiences in detail. |