| 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
|
|
|
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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
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. |