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CTRI Number  CTRI/2019/06/019902 [Registered on: 27/06/2019] Trial Registered Prospectively
Last Modified On: 10/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Coping strategies in advanced lung cancer patients referred for specialist palliative care – validation of Brief COPE inventory in Hindi 
Scientific Title of Study   Coping strategies in advanced lung cancer patients referred for specialist palliative care – validation of Brief COPE inventory in Hindi 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jayita Deodhar 
Designation  Adhoc Officer In Charge 
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative Medicine Room number 75 Tata Memorial Hospital Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Shamali poojary  
Designation  Junior resident 
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative Medicine Room number 75 Tata Memorial Hospital Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9769038733  
Fax    
Email  shamalipoojary8@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jayita Deodhar 
Designation  Adhoc OIC 
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative Medicine Room number 75 Tata Memorial Hospital Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  jukd2000@yahoo.co.uk  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, E Borges road, Parel Mumbai 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Hospital E Borges road Parel mumbai 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Jayita Deodhar  Tata Memorial Hospital  Department of Palliative Medicine ,Room 75, Tata Memorial Hospital E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA 
9892358023

jukd2000@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C34||Malignant neoplasm of bronchus andlung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patients with advanced lung cancer
2.Newly referred to Department of Palliative Medicine (outpatients and inpatients) or attending follow up (clinic based or home based)
3.Age above 18 years and willing to participate
4.Able to read and understand the appropriate language (English/Hindi)
5.Able to give written informed consent for face to face or telephonic contact for questionnaire administration 
 
ExclusionCriteria 
Details  1.Unstable medical/psychiatric condition requiring emergency treatment.
2.Communication difficulties .
3.Inability to read the questionnaire due to illiteracy.
4.Inability to read the questionnaire due to cognitive or physical impairment .
5.Patients presenting with acute symptoms requiring immediate medical attention.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Part I and II
Cultural adaptation of English version
Face validity
Translation of the Brief COPE into Hindi
Understandability, language, time to complete, etc of the questionnaire by 10% of the participants

Part III
Reliability of Brief COPE as measured by Cronbach’s alpha
Discriminant validity for construct validity.
Confirmatory Factor analysis 
Only at First visit 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="340"
Sample Size from India="340" 
Final Enrollment numbers achieved (Total)= "340"
Final Enrollment numbers achieved (India)="340" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2019 
Date of Study Completion (India) 09/02/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 09/02/2021 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Lung cancer is the most common cancer worldwide in males and females combined, accounting for 11.6% of the total cancer patients and  the leading cause of cancer death  accounting for 18.4% of the total cancer deaths. It is the expected to be the 6th most common cause of death by 2030. In India, according to GLOBOCAN 2018, approximately 70,000 new cases of lung cancer were estimated in male and female combined with a very high mortality rate.

At every stage of the disease, patients with lung cancer can find themselves dealing with distressing and difficult situations. They can develop various problems like sadness, depression and other psychological symptoms which can even interfere with their daily functioning.

Patients with incurable lung and gastrointestinal cancer who received Early Palliative Care (EPC) showed increased use of approach-oriented coping, associated with better Quality of Life and decreased negative symptoms like depression.

Most of the studies done in the area of coping strategies in advanced lung cancer are from developed countries where the sociodemographic scenarios are different from developing countries. The studies done in India on coping strategies have included advanced cancer patients in general. No studies have addressed coping strategies in advanced lung cancer patients specifically and in specialist palliative care setting, to the best of our knowledge.Also Brief COPE has not been validated in Hindi version for use in this group of patients.

The aim for this study is to validate the Brief COPE in Hindi language to assess the coping strategies of advanced lung cancer patients referred for specialist palliative care, in the context of a tertiary care cancer centre in a developing country.

 
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