| CTRI Number |
CTRI/2024/09/073463 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Association of Financial Burden with Survival Status and Quality of Life of Cancer patients |
|
Scientific Title of Study
|
To evaluate the economic burden of cancer on cancer patients and society |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajneesh Singh |
| Designation |
Principal Investigator |
| Affiliation |
Banasthali Vidyapith |
| Address |
Department of Statistics
Banasthali Vidyapith
Vanasthali Rd, Aliyabad, Radha Kishnpura, Rajasthan 304022
Tonk
RAJASTHAN
304022
India |
| Phone |
8860215963 |
| Fax |
|
| Email |
Rajneeshyog@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. H. S Singh |
| Designation |
Physician |
| Affiliation |
Swami Harshankaranand Ji Hospital & Research Cente |
| Address |
Swami Harshankaranand Ji- Hospital & Research Center,
Bhikaripur Crossing,
Opposite Union Bank Of India, B.H.U Road
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8860215963 |
| Fax |
|
| Email |
inference.infinity@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajneesh Singh |
| Designation |
Principal Investigator |
| Affiliation |
Banasthali Vidyapith |
| Address |
Banasthali Vidyapith
Department of Statistics
Vanasthali Rd, Aliyabad, Radha Kishnpura, Rajasthan 304022
Tonk
RAJASTHAN
304022
India |
| Phone |
8860215963 |
| Fax |
|
| Email |
rajneeshyog@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankhya Incorpoartion
276, DSR Ridge, 6th Cross Rd, Domlur I Stage, 1st Stage, Domlur, Bengaluru, Karnataka, 560071
India |
|
|
Primary Sponsor
|
| Name |
RAJNEESH SINGH |
| Address |
Domlur 2nd Stage Road.
Building Name - MC House / 276
City- Bengaluru
State - Karnataka
Pin Code- 560071
Country - India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| RAJNEESH |
Charak Hospital |
OPD- General Physician Ward. (Room No. 100)
Jehangirabad, Old Nav Bharat Press Building ,
Bhopal - 462001
Madhya Pradesh
Bhopal
MADHYA PRADESH |
8860215963
rajneeshyog@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee – CHARAK HOPITAL ECR/1562/INST/MP/2021 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D||Radiation Therapy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients can able to read the informed consent.
Having a ID Proof for the Age and other details.
|
|
| ExclusionCriteria |
| Details |
No minor participants will be enrolled. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Quality of Life of Cancer Patients |
After - 3 months, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the association of financial stress and QoL |
3, 6 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
16/09/2024 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
One important indicator of a cancer diagnosis is quality of life (QoL). The length of the therapy, the severity of the condition, and the cost of the new medication are some of the variables that affect the direct and indirect costs of cancer care. As a result, this study presents the relationship between financial expenses and quality of life in cancer patients. |