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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C34||Malignant neoplasm of bronchus andlung, |
|
Intervention / Comparator Agent
|
|
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
|
|
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. |