| CTRI Number |
CTRI/2025/08/092366 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to develop and test a tool to improve the professional skills of nurses working in cancer chemotherapy units in Mumbai. |
|
Scientific Title of Study
|
Development of a Nursing professional excellency tool for Nursing officers in chemotherapy units at a tertiary cancer care center, Mumbai. |
| Trial Acronym |
NPET |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4743 . Version 1.2 Date - 14/6/25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prathepa Jagdish |
| Designation |
Professor |
| Affiliation |
Department Of Nursing,Tata Memorial Hospital, Mumbai |
| Address |
Department of Nursing,Room No.1311, 13th Floor,Homi Bhabha Building ,Tata Memorial Hospital,
Dr.E.Borges Marg Parel.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869220441 |
| Fax |
|
| Email |
prathepa_jagadish@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prathepa Jagdish |
| Designation |
Professor |
| Affiliation |
Department Of Nursing,Tata Memorial Hospital, Mumbai |
| Address |
Department of Nursing, Room No.1311, 13th Floor,Homi Bhabha Building ,Tata Memorial Hospital,
Dr.E.Borges Marg Parel.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869220441 |
| Fax |
|
| Email |
prathepa_jagadish@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priya Dadarao Kale |
| Designation |
Final year M.Sc.Nursing student |
| Affiliation |
Department Of Nursing,Tata Memorial Hospital, Mumbai |
| Address |
Department of Nursing,Room No.1311, 13th Floor, Homi Bhabha Building ,Tata Memorial Hospital,
Dr.E.Borges Marg Parel.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9096173442 |
| Fax |
|
| Email |
priyakale2695@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr.E.Borges Marg Parel,Mumbai,Maharashtra.Pin Code-400012, India
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prathepa Jagdish |
ACTREC |
Sector 22, Utsav Chowk- CISF road, Owe, Camp, Kharghar, Navi Mumbai, Maharashtra, 410210, India
Raigarh
MAHARASHTRA |
09869220441
prathepa_jagadish@rediffmail.com |
| Dr Prathepa Jagdish |
Tata Memorial Hospital |
Annex Building, Tata Memorial Hospital,E Borges Road, Parel Mumbai- 400012, Maharashtra, India
Mumbai
MAHARASHTRA |
09869220441
prathepa_jagadish@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee I , 3rd Floor Main Building , Tata Memorial Hospital, Parel, Mumbai. |
Approved |
| Institutional Ethics Committee I , 3rd Floor Main Building , Tata Memorial Hospital, Parel, Mumbai. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NOT APPLICABLE ( AS THERE IS NO MEDICAL / CLINICAL CONDITION BEING STUDIED) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Nurses who are working at Tata Memorial Center, for more than one year of experience
as a permanent staff. Both Male and female Nursing officers.
2. Qualification as GNM/ Post basic/ BSc Nursing/ MSc Nursing
3. Working in chemotherapy areas- CT, CR, injection room ,day
care.
4. Those who are able to follow English.
|
|
| ExclusionCriteria |
| Details |
1. Nurses who are in surgical, radiation therapy, operation theatre, OPD.
2. Unwilling or unavailable to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To develop a nursing professional excellency tool for nursing officers at a tertiary cancer care
center |
At the time of tool development and content validation (one-time activity, estimated within 2 months of enrollment).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To check the reliability of the tool on nursing staff |
After tool development, during field testing on 60 nursing officers (within 2 months of validation).
|
2.To find out the association between demographic data and nursing professional excellency
tool. |
At the time of questionnaire administration (cross-sectional, during final data collection phase). |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
13/08/2025 |
| 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="2"
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
|
The professional excellency tool, which will be developed, includes clinical judgment,
communication, professionalism, values, and evidence-based practice, which will enhance the nurse’s
overall skills, keep them updated with best practices, and ensure professional growth. The nursing
professional excellency focuses on professional responsibilities, decision-making and advocacy,
professional practice and leadership, self-motivation, therapeutic relationships with patients, confidence, and teaching and coaching peers.
The traditional methods of nursing used earlier were fulfilling and ensured nurses basic skills, knowledge, and regulatory requirements for clinical practice. The methods used were checklists,
written exams, and limited use of technology. It focuses on a nurse’s individual excellency in
routine tasks, which ensures safe, standardized care and adherence to protocols and policies. It only
prepares nurses to meet basic job requirements, whereas the professional excellency tool enhances
advanced nursing practice, efficiency, and innovation beyond basic competence. It aims for
continuous improvement and innovation, improves efficiency, reduces errors, and helps nurses to
develop leadership skills, specialize, and adapt to future healthcare trends.
The study aims to develop a new professional excellency tool for nursing officers in
chemotherapy units at a tertiary cancer care center in Mumbai. The tool consists of the
characteristics and the domains that are essential to reduce mistakes, improve patient care, and
assure compliance with hospital and regulatory requirements. It helps in the accreditation process,
making guidelines and improving SOPs. The development of the tool was done, and it was given to 15
experts for the content validation of the tool. The refined tool will be used to check the reliability
of the tool on 60 nursing officers by the purposive sampling method. Collection of data will be for 2
months. This tool will also find out the association between demographic data and the professional excellency tool. |