| CTRI Number |
CTRI/2025/07/090833 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nurse led interventions ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How nurses can help lung cancer patients manage their symptoms: A trial comparing two different treatment approaches |
|
Scientific Title of Study
|
Efficacy of nurse led interventions on Symptom Cluster among Lung cancer patients- A Randomised Control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumana Sen |
| Designation |
M.Sc Nursing 1st year student |
| Affiliation |
COLLEGE OF NURSING, AIIMS, RAIPUR |
| Address |
College of Nursing, AIIMS, RAIPUR, Chhatisgarh
AIIMS RAIPUR
Raipur
CHHATTISGARH
492099
India |
| Phone |
07076194738 |
| Fax |
|
| Email |
sumanasen2213@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Veena Verma |
| Designation |
Lecturer/AP |
| Affiliation |
COLLEGE OF NURSING, AIIMS, RAIPUR |
| Address |
College of Nursing, AIIMS, RAIPUR, Chhatisgarh
AIIMS RAIPUR
Raipur
CHHATTISGARH
492099
India |
| Phone |
9977314448 |
| Fax |
|
| Email |
vinujay8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumana Sen |
| Designation |
M.Sc Nursing 1st year student |
| Affiliation |
COLLEGE OF NURSING, AIIMS, RAIPUR |
| Address |
College of Nursing, AIIMS, RAIPUR,Chhatisgarh
AIIMS RAIPUR
Raipur
CHHATTISGARH
492099
India |
| Phone |
07076194738 |
| Fax |
|
| Email |
sumanasen2213@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sumana sen |
| Address |
College of Nursing, AIIMS, Raipur
C.G. |
| Type of Sponsor |
Other [Self Funding] |
|
|
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 |
| Sumana Sen |
AIIMS Hospital, Raipur |
IPD and Day care of Department of Pulmonology of AIIMS, RAIPUR
Raipur
CHHATTISGARH |
07076194738
sumanasen2213@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS, Raipur |
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 interventions |
Diaphragmatic breathing and pursed lip breathing for breathlessness
Sips of water, steam inhalation and huff cough for cough
ROM exercise and Patient tailored exercises (Brisk walking) for fatigue. |
| Comparator Agent |
Standard routine care |
Standard routine care that is provided to all lung cancer patients, that will be provided to the control group |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with confirmed diagnosis of lung cancer (including small cell or non-small cell lung cancer and mesothelioma)
W.H.O. Performance Status 0-2 and are willing to participate |
|
| ExclusionCriteria |
| Details |
Critically ill patients of Lung cancer requiring ICU admissions
Samples who cannot read and write in English and Hindi language |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is to assess the effectiveness of nurse led interventions on Symptom Cluster. |
Follow up will be taken on 3-5 weeks and on 6-8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome is to find out the association between selected demographic variables & baseline levels of cough, breathlessness & fatigue. |
At baseline & at 4-6 weeks & at 6-8 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/11/2025 |
| Date of Study Completion (India) |
12/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
As lung cancer is one of the highest cause of mortality and the main focus is given for chemotherapy an radiation therapy for these patients, they also suffer a lot from breathlessness, cough anf fatigue which worsen their quality of life. Thus certain nurse led interventions will be given to allieviate the suffering of these patients. The study aims to compare the efficacy the nurse led interventions on the symptom cluster of breathlessness, cough and fatigue. A total of 50 participants will be taken (25 in each experimental and control group). The participants will be randomly allocated in experimental and control group by using Block Randomization method and Allocation Concealment will be maintained by SNOSE method. Initially consent will be taken and then patients will be screened using W.H.O Performance Status score and those with score between 0-2 will be taken for the study. The participants will be given a detailed instruction regarding the interventions whereas the control group will be given the standard care. The nurse led interventions include Diaphragmatic and Pursed lip breathing for Breathlessness; Sips of water, Steam inhalation and Huff cough technique for Cough and ROM exercises and Patient tailored exercises(walking) for Fatigue. 3 Standardized tools will be used for collecting the data. (Dyspnoea-12 tool, The Leicester Cough Questionnaire tool and The FACIT-Fatigue version 4 tool). Data will be collected at baseline and ate 3-5 weeks and again at 6-8 weeks of follow-up. Daily telephonic conversations along with a log book will be given to the patients for better compliance. After collection of the data, the data will be analysed by using differential and infereantial statistics. |