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CTRI Number  CTRI/2022/02/040075 [Registered on: 07/02/2022] Trial Registered Prospectively
Last Modified On: 03/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational Qualitative Study 
Study Design  Other 
Public Title of Study   Understanding the financial burden in patients with advanced cancer on palliative care 
Scientific Title of Study   Understanding the experience of financial toxicity in patients with metastatic cancers referred to specialist palliative care in India – A qualitative study 
Trial Acronym   
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  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative Medicine Main Building Ground Floor 75, Tata Memorial Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  241770007148  
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jayita Deodhar 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative Medicine Main Building Ground Floor 75, Tata Memorial Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  241770007148  
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Dr Sachin Gunde 
Designation  Junior resident 
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative Medicine Main Building Ground Floor 75, Tata Memorial Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  8108663782  
Fax    
Email  gundesachin@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Dr. Ernest 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  Tata Memorial Hospital  Department of Palliative Medicine, Main Building, Ground floor, Room No. 75, Parel, Mumbai.
Mumbai
MAHARASHTRA 
241770007148

jukd2000@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Indian patients with metastatic cancers of lung, Head & neck and Gynecological origin, either on disease modifying treatment or best supportive care, who are referred to or receiving specialist palliative care services in the hospital.
2. Patients who had registered under general or private categories, who may be availing any Government scheme or support, at the time of enrollment for cancer treatment at our hospital.
3. Patients ≥ 18 years of age.
4. Patients who have received cancer directed treatment for at least 6 months.
5. Patients who are willing to participate in the study and can sign informed consent form.
6. Patient who are able to communicate in Hindi/Marathi/English.
 
 
ExclusionCriteria 
Details  1. Patients with communication difficulties,
2. Patients with intellectual disability and cognitive impairment (as assessed clinically).
3. Patients with any distressing severe symptoms at the time of presentation requiring emergency medical management.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Exploring the experience of financial toxicity in patients with metastatic
cancers. 
Baseline at evaluation 
 
Secondary Outcome  
Outcome  TimePoints 
Understanding the demographic and socio-economic factors associated with
financial toxicity in metastatic cancer patients.
 
Baseline at evaluation 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   10/02/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Will be published after thesis submission and approval. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Cancer is the leading cause of morbidity and incresaed mmortality worldwide. The incidence is increasing with aging population. 
While, huge research and developmnet initiatives are underway to improve the existing cancer care infrastructure, the disease continues to takle heavy toll on ptaient’s lives.
With the advent of technological advances, newer diagnostic and therapeutic options have become available in last two decades. Although, thses new drugs are more effective, the affordibility is a huge challenge.
In medicine , the term financial toxicity (FT) is used to describe problems  a patient experiences in relation to cost of medical care. FT is an unintended outcome- an adverse event of cancer care given the cost of treatment. It has two key components- 1) Objective financial burden, in the form of cost of vtreatment patient has to pay, and 2) Subjective financial distress- which is reflected in form of worry, anxiety, loss od assets and savings.
FT affects patient’s quality of life and access to medical care. To cope with financial burden, patients take less than prescribed medicine, or may at times completely avoid to purchase them. They compromise leisure activity, may spoend less on food and clothings, have to work for longer hours, just to meet increased financial expenses.  Patients with metastatic disease, experience reduction in quality of life domains including- physical, social, spiritual, and emotional well being. Same is true for adult survivors of childhood cancers.
Lesser knowledge and awareness of available healthcare benefit options, insurance schemes sontributes to some extents towards financial stress during treatment. 
We note that the concept of financial toxicity, though well reported in literature, has not been so well reported in Indain cancer patients. In developing country like India, the effects of economic aspects of cancer care are far more reaching with long term effects on patients and their families.  So we wish to explore and report the experience related to financial toxicityin Indian cancer patients. 
This study aims to understand the financial toxicity as experiencxed by the patients with metastatic cancers referred to specialist palliative care. It will help to add information on fianancial domain of cancer care in Indian population and will help in making future strategies to tackle financial stress of cancer care. 
 
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