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CTRI Number  CTRI/2013/11/004128 [Registered on: 04/11/2013] Trial Registered Retrospectively
Last Modified On: 03/11/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Standard palliative care]  
Study Design  Other 
Public Title of Study   Early palliative care in patients with advanced lung cancer 
Scientific Title of Study   A study to assess the feasibility of introducing early palliative care in ambulatory patients with advanced lung cancer 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jayita Deodhar 
Designation  Assoc Prof 
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital Dr. E. Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jayita Deodhar 
Designation  Assoc Prof 
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital Dr. E. Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Dr Jayita Deodhar 
Designation  Assoc Prof 
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital Dr. E. Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax    
Email  jukd2000@yahoo.co.uk  
 
Source of Monetary or Material Support  
Tata Memorial Hospital 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr. E. Borges Road Parel Mumbai 400012 
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 
Dr Jayita Deodhar  Room 115 Dept of Palliative Medicine Tata Memorial Hospital  Dr E Borges Road Parel Mumbai 400012
Mumbai
MAHARASHTRA 
02224177000

jukd2000@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Tata Memorial Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Ambulatory patients with advanced lung cancer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Standard palliative care  Pain and symptom management and patient counselling The patients meet the palliative care team on the day of referral and then every month thereafter for 6 months." 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Advanced Lung cancer patients (Stage IV)
2. ECOG 0, 1 and 2
3. Patient who can adhere to followup schedule at tata Memorial Hospital
4. Age more than 18 years
5. Written informed consent
 
 
ExclusionCriteria 
Details  1. ECOG > 2
2. Expected survival <4 weeks
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Greater than 60% of the referred patients have met the palliative care team
Greater tha 50% of the referred patients have completed the EORTC QLQ 30 and LC 13 and ESAS
 
Baseline, monthly thereafter till 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To check the symptom burden at baseline and at follow up using ESAS
To check the quality of life of patients using EORTC QLQ 30 and LC 13 at baseline and at follow up. 
Baseline, monthly thereafter till 6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   21/09/2013 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Brief Summary   Currently lung cancer is the fourth largest cause of cancer mortality in India, accounting for almost 8% of all cancer related deaths in the country. Majority of patients with advanced lung cancer have significant physical and psychological distress through the treatment period, maximum severity being three months prior to death. Thus, they are a population requiring early maximum palliation for symptom alleviation and addressing family caregiver needs of more information and communication and psychosocial support. 

The purpose of the study is to assess the feasibility of early palliative care in ambulatory patients with advanced lung cancer and to determine the symptom burden (using Edmonton Symptom Assessment Scale) and quality of life (using EORTC QLQ C30 and Lung Cancer version EORTC QLQ-LC13 at baseline and follow up over 6 months period.

The study hypothesis is that at least 60% of ambulatory patients with advanced lung cancer enrolled for the study will be able to complete the planned palliative care visits and at least 50% will be able to complete the EORTC QLQ C30 and LC 13.
 
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