| CTRI Number |
CTRI/2018/07/014912 [Registered on: 17/07/2018] Trial Registered Prospectively |
| Last Modified On: |
16/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
To provide nursing education to the cancer patients so that chemotherapy related side effects can be minimised. |
|
Scientific Title of Study
|
A randomized Controlled Trial to evaluate the effectiveness of a “nursing intervention protocol†on prevention, early detection and management of Chemotherapy induced Neutropenic complications among the patients admitted/attending selected oncology units, PGIMER,2017-19. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pramod Kumar Nagar |
| Designation |
Master of Nursing |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Room no.132,National Institute of Nursing Education,PGIMER,Chandigarh-160014
Chandigarh
CHANDIGARH
160014
India |
| Phone |
8727802011 |
| Fax |
|
| Email |
nagarp2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rupunder Kaur |
| Designation |
Nursing Tutor |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Room no. 132, National Institute of Nursing Education,PGIMER, Chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09878033748 |
| Fax |
|
| Email |
drsukhpalkaur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pramod Kumar Nagar |
| Designation |
Master of Nursing |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Room no. 132, National Institute of Nursing Education,PGIMER,Chandigarh-160014
Chandigarh
CHANDIGARH
160014
India |
| Phone |
8727802011 |
| Fax |
|
| Email |
nagarp2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pramod Kumar Nagar,# 300, Greenvalley ,Sarangpur, Chandigarh-160014 Mobile no. 8727802011 Email ID: nagarp2@gmail.com |
|
|
Primary Sponsor
|
| Name |
Pramod Kumar Nagar |
| Address |
#300 GreenValley, Sarangpur, chandigarh-160014 |
| Type of Sponsor |
Other [Pramod Kumar Nagar (Self)] |
|
|
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 |
| Pramod Kumar Nagar |
Postgraduate Institute of Medical Education and Research, Chandigarhchandigarh |
Department of Radiotherapy, Day care of Radiotherapy, Room no. 505, Haemato-oncology unit of Advanced paediatric centre 4th floor Room no. 404,Advanced paediatric centre day care Room no. 410
Chandigarh
CHANDIGARH |
8727802011
nagarp2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients on chemotherapy , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nursing intervention protocol |
Nursing Intervention Protocol in terms of information provided in the form of booklet.Patients will register in my study as they come for chemotherapy for first time and than follow up after each cycle up to three cycle of chemotherapy which may be weekly, two weekly or any other. |
| Comparator Agent |
routine care |
routine information |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
patients equal to less than 16 years of age |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the Prevalence of manifestations of neutropenia:
Fever
Fatigue
Nausea/vomiting
Diarrhoea
Anorexia
Weight loss
Alopecia
Oral mucositis
|
15 July 2018 to 30 September 2018
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Decreased hospital admission due to chemotherapy induced neutropenia and
reduced the cost of treatment |
After completion of 1 ,2 ,3 cycle of chemotherapy.15 July 2018 to 30 September 2018 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
25/07/2018 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"none yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Randomized Controlled Trial to evaluate the effectiveness of a “Nursing Intervention Protocol†on prevention, early detection and management of Chemotherapy Induced Neutropenic Complications among the patients admitted/attending selected oncology units, PGIMER, Chandigarh 2017-19. this is postgraduate thesis for the patients who are on chemotherapy and to prevent the neutopenia in patients and we will provide information to caregivers and nurses so that they can help the child for the prevention and early detection of neutropenia |