| CTRI Number |
CTRI/2024/03/064160 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study comparing the performance status assessments reported by clinician versus patients themselves.
|
|
Scientific Title of Study
|
Is patients self-reported performance status comparable to the clinician-reported performance status in predicting 30-day morbidity - a prospective comparative study from a tertiary cancer center in south India. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandini Devi R |
| Designation |
Assistant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
Room number 7
Division of Medical Oncology
Department of Clinical Hematology and Medical Oncology
Malabar Cancer Centre
Moozhikkara. P.O
Thalassery
Kannur
KERALA
670103
India |
| Phone |
04902399255 |
| Fax |
|
| Email |
drnandiniamutha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandini Devi R |
| Designation |
Assistant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
Room number 7
Division of Medical Oncology
Department of Clinical Hematology and Medical Oncology
Malabar Cancer Centre
Moozhikkara.P.O
Thalassery
Kannur
KERALA
670103
India |
| Phone |
04902399255 |
| Fax |
|
| Email |
drnandiniamutha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandini Devi R |
| Designation |
Assistant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
Room number 7
Division of Medical Oncology
Department of Clinical Hematology and Medical Oncology
Malabar Cancer Centre
Moozhikkara.P.O
Thalassery
Kannur
KERALA
670103
India |
| Phone |
04902399255 |
| Fax |
|
| Email |
drnandiniamutha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Malabar cancer Center
Moozhikkara Post office
Kodiyeri , Thalassery
Kannur
Kerala
Pin - 670103 |
|
|
Primary Sponsor
|
| Name |
Dr Nandini Devi R |
| Address |
Department of Medical Oncology
Malabar Cancer Center
Moozhikkara Post office
Kodiyeri, Thalassery
Kannur
Kerala
Pin 670103 |
| 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 |
| Dr Nandini Devi R |
Malabar Cancer Center |
Room no:7
Division of Medical Oncology
Department of Clinical Hematology and Medical Oncology
Kannur
KERALA |
9496369909
drnandiniamutha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Malabar Cancer Centre, Thalassery , Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
98.00 Year(s) |
| Gender |
Both |
| Details |
All patients who are planned for first cycle of cytotoxic chemotherapy |
|
| ExclusionCriteria |
| Details |
Those who cannot read,comprehend and answer the study questionnaire |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| level of agreement between patient-assessed and clinician-assessed performance status and compare the odds of these assessments in predicting 30-day morbidity |
Day 1 and Day-30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of Performance status assessments with 30-day morbidity |
30-day morbidity |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
Final Enrollment numbers achieved (Total)= "215"
Final Enrollment numbers achieved (India)="215" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2024 |
| Date of Study Completion (India) |
31/08/2024 |
| Date of First Enrollment (Global) |
25/03/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
|