| CTRI Number |
CTRI/2024/03/064546 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral
Other (Specify) [NURSE LED INTERVENTIONS BREATHING EXERCISE] |
| Study Design |
Other |
|
Public Title of Study
|
NURSE LED INTERVENTIONS ON CLINICAL AND
PSYCHOLOGICAL PARAMETERS OF
PATIENTS SUFFERING WITH LUNG
CANCER |
|
Scientific Title of Study
|
EFFECTIVENESS OF NURSE LED
INTERVENTIONS ON CLINICAL AND
PSYCHOLOGICAL PARAMETERS OF
PATIENTS SUFFERING WITH LUNG
CANCER |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SRIDHAR A |
| Designation |
Ph D SCHOLAR |
| Affiliation |
KLES INSTITUTE OF NURSING SCIENCES |
| Address |
MEDICAL SURGICAL NURSING DEPARTMENT
KLES INSTITUTE OF NURSING SCIENCES
HUBBALLI
Dharwad
KARNATAKA
5830031
India |
| Phone |
8867998603 |
| Fax |
|
| Email |
srinithin21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJAY M PEERAPUR |
| Designation |
PRINCIPAL CUM PROFESSOR AND HOD DEPT. OF MEDICAL SURGICAL NURSING |
| Affiliation |
KLES INSTITUTE OF NURSING SCIENCES |
| Address |
KLES INSTITUTE OF NURSING SCIENCES
VIDYANAGAR
HUBBALLI TQ
Dharwad
KARNATAKA
5830031
India |
| Phone |
9945076768 |
| Fax |
|
| Email |
sanjupeerapur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANJAY M PEERAPUR |
| Designation |
PRINCIPAL CUM PROFESSOR AND HOD DEPT. OF MEDICAL SURGICAL NURSING |
| Affiliation |
KLES INSTITUTE OF NURSING SCIENCES |
| Address |
KLES INSTITUTE OF NURSING SCIENCES
VIDYANAGAR
HUBBALLI TQ
Dharwad
KARNATAKA
5830031
India |
| Phone |
9945076768 |
| Fax |
|
| Email |
sanjupeerapur@gmail.com |
|
|
Source of Monetary or Material Support
|
| HCG NMR CANCER CENTRE HUBBALLI |
| KARNATAKA CANCER THERAPY AND REASEARCH INSTITUTION HUBBALLI |
| KLES SUCHIRAYU HOSPITAL HUBBALLI |
| RADON CANCER CENTRE HUBBALLI |
|
|
Primary Sponsor
|
| Name |
SRIDHAR A |
| Address |
Ph D SCHOLAR
MEDICAL SURGICAL NURSING DEPARTMENT
KLES INSTITUTE OF NURSING SCIENCES
HUBBALLI |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SRIDHAR A |
HCG NMR CANCER CENTRE |
DESHPANDE NAGAR
HUBBALLI
Dharwad
KARNATAKA |
8867998603
srinithin21@gmail.com |
| SRIDHAR A |
KARNATAKA CANCER THERAPY AND RESEARCH INSTITUTION |
NAVANAGAR
HUBBALLI
Dharwad
KARNATAKA |
8867998603
srinithin21@gmail.com |
| SRIDHAR A |
KLES SUCHIRAYU HOSPITAL |
GOKUL ROAD
HUBBALLI
Dharwad
KARNATAKA |
8867998603
srinithin21@gmail.com |
| SRIDHAR A |
RADON CANCER CENTRE |
OFF GOKUL ROAD
HUBBALLI
Dharwad
KARNATAKA |
8867998603
srinithin21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLES INSTITUTE OF NURSING SCIENCES ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NURSE LED INTERVENTION OF HEALTH ASSESSMENT COUNSELLING |
Counselling and behavioral techniques 5 minutes for managing anxiety,
depression and improving quality of life.
duration will be 5 minutes. |
| Intervention |
NURSE LED INTERVENTION on HEALTH AWARENESS CANCER |
Health awareness cancer teaching programme of 30 minutes duration on lung
cancer, risk factors, clinical features, staging, diagnostic tests, treatment
modalities and nonphormacological interventions.
Duration will be 30 minutes. |
| Intervention |
NURSE LED INTERVENTIONS OF BREATHING EXERCISE |
Demonstrations and teaching of breathing exercises of 15 minutes are
included, diaphragmatic breathing exercise, balloon blowing exercise and
exercise with spirometer. It will be recorded details of the breathing exercise
including types of exercise, setting of exercise, level of supervision as well as
patient treatment status and details of exercise prescription including frequency,
duration, intensity, sessions and adherence rate
duration will be 15 minutes |
| Intervention |
NURSE LED INTERVENTIONS OF INDIVIDUAL EDUCATIONAL INTERVENTIONS |
Individual Educational Intervention of 10 minutes for reducing fatigue and pain
management.
Duration will be 10 minutes |
| Comparator Agent |
standard care |
As per Hospital Policy |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering with lung cancer who are
Aged 20 years and above
Are willing to participate in the study.
Are available at the time of data collection.
Can understand Kannada and English |
|
| ExclusionCriteria |
| Details |
Patients suffering with lung cancer who are
Critically ill or in end stage of life.
Having visual and hearing disability |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Nurse led interventions will be effective and enhance the clinical and
psychological parameters of patients suffering with lung cancer and
empower them to participate more effectively in the treatment and selfcare |
Enhance clinical and psychological parameters
1. pre intervention assessment
2. post intervention assessment
3. followed by 4 assessments and 4 interventions for consecutively 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Nurse led interventions will be effective & enhance the clinical and
psychological parameters of patients suffering with lung cancer. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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/ Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="1"
Months="0"
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
|
The Nurse led interventions will be effective and enhance the clinical and psychological parameters of patients suffering with lung cancer and empower them to participate more effectively in the treatment and self care |