| CTRI Number |
CTRI/2022/03/040714 [Registered on: 02/03/2022] Trial Registered Prospectively |
| Last Modified On: |
25/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing Why Do Cancer Patients Seek health Care late and Its Implication In Patient Care |
|
Scientific Title of Study
|
To Assess The Factors Responsible For Delayed Presentation Of Cancer Patients To Tertiary Centre and Its Implication in Patient Care |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Sushma Bhatnagar |
| Designation |
HOD, Dept Of ONCO-ANAESTHESIA AND PALLIATIVE MEDICINE |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room no.243 , Dept of Oncoanesthesia and palliative medicine.
BRAIRCH, AIIMS New Delhi
Aurobindo Marg .
Ansari Nagar
New Delhi-110029
New Delhi
DELHI
110016
India |
| Phone |
9811326453 |
| Fax |
|
| Email |
sushmabhatnagar1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Bhatnagar |
| Designation |
HOD Dept.of ONCO-ANAESTHESIA AND PALLIATIVE MEDICINE |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room no.243
Dept of Oncoanesthesia and palliative medicine
BRAIRCH, AIIMS New Delhi
Aurobindo Marg
Ansari Nagar
New Delhi 110029
New Delhi
DELHI
110016
India |
| Phone |
9811326453 |
| Fax |
|
| Email |
sushmabhatnagar1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushma Bhatnagar |
| Designation |
HOD, Dept. Of ONCO-ANAESTHESIA AND PALLIATIVE MEDICINE |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room no.243
Dept of Oncoanesthesia and palliative medicine
BRAIRCH, AIIMS New Delhi
Aurobindo Marg
Ansari Nagar
New Delhi 110029
New Delhi
DELHI
110016
India |
| Phone |
9811326453 |
| Fax |
|
| Email |
sushmabhatnagar1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
Aurobindo Marg, Ansari nagar
New Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS NEW DELHI |
Aurobindo Marg, Ansari Nagar
New Delhi 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ARKANIL GAIN |
AIIMS, NEW DELHI |
Room no.243
Dept of Oncoanesthesia and palliative medicine
BRAIRCH, AIIMS New Delhi
Aurobindo Marg
Ansari Nagar
New Delhi 110029
New Delhi
DELHI |
9609464613
docgainarkanil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
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 |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Age more than or equal to 18 years.
2 Patients diagnosed with stage III and stage IV malignancy.
3. Any metastatic malignancy.
4. Patient directly presenting to palliative medicine OPD.
5. Patients giving informed consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1.Patients with malignancy who have been diagnosed and treated previously.
2. Patients with early-stage disease (stage I and stage II disease).
3.Patients not giving consent to participate in the study.
4 . Patient with impaired cognitive function
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The cause of delay which can be ignorance, transport issues, stigma, fear .
|
At Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess how the intervention of palliative medicine helped in the course of the patient.
To assess how the intervention of palliative medicine helped in the course of the patient.
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/03/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
THE PATIENTS PRESENTING WITH ADVANCED C=MALIGNANCY FOR THE FIRST TIME IN OUR OPD, AHO DIDNT GET ANY PRIOR CURATIVE TREATMENT WILL BE ASKED ABOUT THE CAUSES OF LATE PRESENTATION. OVER THE 18 MONTHS WE WILL TRY TO ASSESS THE CAUSES AND THE IMPACT PALLIATIVE MEDICINE’S INTERVENTION IN THE PATIENT’S CONDITION WILL HAVE. WE WILL USE A SEMI- STRUCTURED QUESTIONNARE TO ASSESS THE CAUSES. WE WILL ASSESSS THE IMPACT PALLIATIVE MEDICINE HAD ON THE CARE IN THE SUBSEQUENT FOLLOWUPS AFTER 4 WEEKS , |