| CTRI Number |
CTRI/2024/02/062824 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
fever with low blood cell (neutrophil) count |
|
Scientific Title of Study
|
Effect of nurse directed intervention (NDI) on prevention of febrile neutropenia among selected cancer patients receiving chemotherapy in a tertiary care center in Bhubaneswar. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali |
| Designation |
Msc Nursing Student |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
College of Nursing, AIIMS Bhubaneswar, Sijua, Patrapada, Odisha
College of Nursing, AIIMS Bhubaneswar, Sijua, Patrapada, Odisha
Khordha
ORISSA
751019
India |
| Phone |
9870360139 |
| Fax |
|
| Email |
anj301k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mariamma V George |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
College of Nursing, AIIMS Bhubaneswar, Sijua, Patrapada, Odisha
College of Nursing, AIIMS Bhubaneswar, Sijua, Patrapada, Odisha
Khordha
ORISSA
751019
India |
| Phone |
9924861579 |
| Fax |
|
| Email |
nurs_mariamma@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mariamma V George |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
College of Nursing, AIIMS Bhubaneswar, Sijua, Patrapada, Odisha
College of Nursing, AIIMS Bhubaneswar, Sijua, Patrapada, Odisha
Khordha
ORISSA
751019
India |
| Phone |
9870360139 |
| Fax |
|
| Email |
nurs_mariamma@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| Post graduate thesis, investigation was done, investigator is following up the routine investigation done for the patients, undergoing chemotherapy in selected outpatient departments of AIIMS Bhubneswar, so their is no budgetary expenditure in this study, the that will be collected by the investigator |
|
|
Primary Sponsor
|
| Name |
Anjali |
| Address |
College of Nursing, AIIMS Bhubaneswar, sijua, Patrapada, Odisha, 751019 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mariamma V George |
College of Nursing, AIIMS Bhubaneswar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mariamma V George |
AIIMS Bhubaneswar |
1. G Block, Medical oncology Daycare
2. H Block, Radiation Oncology daycare
3. First floor, Block A, Room no. 115, 116, 117.118 Heametology Daycare
4. First Floor, I Block Medical oncology Ward
Khordha
ORISSA |
9924861579
nurs_mariamma@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse- Directed intervention for prevention of febrile Neutropenia |
This will be 30-minute teaching session with an information booklet on the prevention of febrile neutropenia. This will cover topics of personal hygiene, food hygiene, environmental and hand hygiene, and there will be a reinforcement session of 10 minutes on subsequent follow-up. |
| Comparator Agent |
Routine care |
This will be no teaching session with an information booklet on the prevention of febrile neutropenia.
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Aged 15 or above
2. Diagnosed with selected cancer and receiving chemotherapy
3. Able to speak and understand Hindi or Odia
4. Patients who are due for at least 4 months of chemotherapy |
|
| ExclusionCriteria |
| Details |
1. In-patient
2. Visual or hearing impaired;
3. Known cognitive impairment;
4. Known psychiatric illness,
5. Eastern Cooperative Oncology Group (ECOG) performance status score greater than two. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence Febrile Neutropenia |
After 14/21 days (In 1st , 2nd and 3rd follow-up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Knowledge, Self-care practice and Hand-wash competency |
3rd follow-up or After the 2 months of intervention |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
26/02/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a Pretest-posttest control group design to assess the Effect of Nurse-Directed Intervention (NDI) on prevention of febrile neutropenia among selected cancer patients receiving chemotherapy in a tertiary care center in Bhubaneswar.The intervention given with the information booklet consists of a 30-minute individual teaching session on the prevention of febrile neutropenia and a reinforcement session of 10 minutes on subsequent follow-up. There will be three follow-ups with gaps of 14/21 days. Post-test is conducted on the 3rd follow-up. The primary outcome study is the incidence of febrile neutropenia, and the secondary outcome is knowledge, self-care behaviour and hand wash competency.
|