| CTRI Number |
CTRI/2024/01/062149 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to determine whether radiation to older cancer patients have any side effects to their health both physical and mental |
|
Scientific Title of Study
|
Comprehensive Geriatric Assessment And Quality Of Life Assessment In Older Adults With Cancer: Pre And Post Radiation Therapy |
| 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 Rashi Agrawal |
| Designation |
Principal consultant |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality hospital, Radiation oncology department, tower 1, -2 basement
W-3, Sector -1, Vaishali, Ghaziabad
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9891483550 |
| Fax |
|
| Email |
drrashi.ag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashi Agrawal |
| Designation |
Principal consultant |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality hospital, Radiation oncologist department, Tower 1-,2 basement
W-3, Sector -1, Vaishali, Ghaziabad
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9891483550 |
| Fax |
|
| Email |
drrashi.ag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashi Agrawal |
| Designation |
Principal consultant |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality hospital, Radiation oncology department, Tower 1, -2 basement
W-3, Sector -1, Vaishali, Ghaziabad
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9891483550 |
| Fax |
|
| Email |
drrashi.ag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality hospital, pushpanjali, vaishali, Ghaziabad 201012 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| DrMonasweeta bhowmick |
Max super specilaity hospital |
Max super speciality hospital, Radiation oncology department, Tower 1, -2 basement ,W-3, Sector 1, vaishali
Ghaziabad
UTTAR PRADESH |
8240532920
monasweeta1916@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient above 60 years.
Patient Undergoing radiation therapy with curative intent
Diagnosed case of carcinoma |
|
| ExclusionCriteria |
| Details |
Patient undergoing radiation therapy with palliative intent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life and geriatric assessment of older cancer patients 12 weeks after radiation using questionnaire tools like EORTC QLQ 30, 14, SCOPE -C 30 QUESTIONNAIRE ANS LAWTON BRODY I.A.D.L AND GDS SCALE |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NO SECONDARY OUTCOME MEASURED IN THIS STUDY |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/02/2024 |
| 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="0"
Months="4"
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
|
It is a prospective observational study on diagnosed case of carcinoma patients above 60 years old undergoing radiation therapy with curative intent to determine their quality of life and geriatric assessment pre and post radiation, which is based on questionaries |