|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
CTRI |
|
Last refreshed on:
|
21 November 2022 |
|
Main ID: |
CTRI/2014/12/005248 |
|
Date of registration:
|
04-12-2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Psychological Issues And Quality Of Life In Patients
With Low Grade Gliomas
|
|
Scientific title:
|
Prospective Psychiatric, Cognitive And Quality Of Life Evaluation In Patients
With Low Grade Gliomas
|
|
Date of first enrolment:
|
26-12-2013 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Completed |
|
URL:
|
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8145 |
|
Study type:
|
Observational |
|
Study design:
|
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
India
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr Ajita Nayak
|
|
Address:
|
Dept of Psychiatry
Seth GS Medical College and KEM Hospital
Parel
Mumbai
400012
Mumbai, MAHARASHTRA
India |
|
Telephone:
|
02224107492 |
|
Email:
|
ajitanayak@rediffmail.com |
|
Affiliation:
|
Seth GS Medical College and KEM Hosptial |
|
|
Name:
|
Dr Jayita Deodhar
|
|
Address:
|
Room 18 Golden Jubilee Building Basement
Tata Memorial Hospital
Dr. E. Borges Road
Parel
Mumbai
400012
Mumbai, MAHARASHTRA
India |
|
Telephone:
|
02224107492 |
|
Email:
|
ajitanayak@rediffmail.com |
|
Affiliation:
|
Seth GS Medical College and KEM Hosptial |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1) Age group: 18-65 yrs
2) Definitive histopathological diagnosis of low grade glioma
3) Karnofsky Performance Status Scale (KPS) >70
4) Radiation treatment naïve patient
Exclusion criteria: 1) Patient not willing to give informed consent
2) Patient non compliant to psychiatric/cognitive assessment.
3) Patients with inability to communicate.
4) High grade glioma- Grade: III/IV
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
|
Health Condition 1: null- Low grade gliomas post-operative
Health Condition 2: C719- Malignant neoplasm of brain, unspecified
|
|
Primary Outcome(s)
|
1. Psychiatric morbidity (depression and anxiety)
2. Cognitive deficits
Timepoint: Baseline, 3 months and 6 months
|
|
Secondary Outcome(s)
|
1. Quality of life
2. Demographic dataTimepoint: 1. Quality of life - Baseline, 3 months and 6 months
2. Demographic data - Baseline
|
|
Source(s) of Monetary Support
|
|
Tata Memorial Hospital
Dr E Borges Road
Parel
Mumbai 400012
|
|
Ethics review
|
Status: Approved
Approval date: 26/11/2013
Contact:
Institutional Review Board, Tata Memorial Hospital
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|