| CTRI Number |
CTRI/2017/06/008920 [Registered on: 28/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
19/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
A survey to assess the knowledge and practice followed by nurses during administration of chemotherapy |
|
Scientific Title of Study
|
A Study to assess the knowledge and practice followed by nurses during administration of chemotherapy at tertiary cancer care centre, Mumbai |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1801 Date 23/12/2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Swapna Joshi |
| Designation |
Nursing superintendent cum professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Nursing Administration Office E Borges Marg Tata Memorial Hospital Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177007256 |
| Fax |
|
| Email |
jswapna96@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Swapna Joshi |
| Designation |
Nursing superintendent cum professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Nursing Administration Office E Borges Marg Tata Memorial Hospital Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177007256 |
| Fax |
|
| Email |
jswapna96@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Hardiljeet Kaur |
| Designation |
PG Student |
| Affiliation |
Tata Memorial Hospital |
| Address |
Golden jublee building,6th floor, Room no. 608, Tata Memorial Hospital,Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9579079292 |
| Fax |
|
| Email |
hardiljeet.kaur@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Marg Parel Mumbai |
| 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 |
| Swapna S Joshi |
Tata Memorial Hospital |
General day care Private day care Chemotherapy ward 12th floor main building and chemotherapy ward on 7th and 9th floor of HBB Block
Mumbai
MAHARASHTRA |
02224177007256
jswapna96@yahoo.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 |
Participants selected for the present study are healthy nurses who are administering chemotherapy |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
26.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Nurses who are working in chemotherapy administration areas - Day care Wards OPD casualty for more than one year. Nurses who are willing to participate. |
|
| ExclusionCriteria |
| Details |
Nurses who are not permanent staff of Tata Memorial Hospital |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome will be in the form of score of knowledge and practice that will be measured.
For knowledge above 75 percent will be regarded as good knowledge 50-75 percent will be regarded as average knowledge and less than 50 percent will be regarded as poor knowledge.
For practice less than 50 percent poor practice 51- 60 percent will be fair practice 61-70 good practice 71- 80 percent very good practice 81-90 percent excellant practice and more than 90 percent outstanding practice |
primary outcome is assessed on single time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Based on the primary outcome nurses may have good or bad knowledge and practice. |
Secondary outcome will be assessed only at single point of time. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
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)?
|
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Brief Summary
|
Purpose: The puprose of the study is to assess the level of knowledge and practices of nurses administering chemotherapy drugs at Tata Memorial Hospital. It has been undertaken so to evaluate the implementation of standard operating procedure for chemotherapy administration and also to determine the knowledge nurses have regarding chemotherapy drug preparation and administration. To assess the knowledge structured questionnaire has been prepared and to observe the practice checklist of the procedure has been prepared. Both are validated by 11 subject experts.Data collection period will be six weeks.Informed consent will be taken as per the suggestion of Institutional review board.Anonymity will be maintained during observation of the procedure.Data will be presented in the form of frequency and percentages.
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