| CTRI Number |
CTRI/2013/12/004247 [Registered on: 26/12/2013] Trial Registered Retrospectively |
| Last Modified On: |
24/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Depression in adult patients with advanced cancer in palliative care services |
|
Scientific Title of Study
|
Prevalence of depression in adult patients with advanced cancer newly referred for palliative care services |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayita Deodhar |
| Designation |
Assoc Prof |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room 18
Golden Jubilee Building Basement
Tata Memorial Hospital
Dr E Borges Road
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Rao |
| Designation |
Fellow, Palliative Medicine |
| Affiliation |
Tata Memorial Hospital |
| Address |
c/o Dr. Jayita Deodhar
Room 18
Golden Jubilee Building Basement
Tata Memorial Hospital
Dr E Borges Road
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
raoseema@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayita Deodhar |
| Designation |
Assoc Prof |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room 18
Golden Jubilee Building Basement
Tata Memorial Hospital
Dr E Borges Road
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Road
Parel
Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jayita Deodhar |
Room 115, Main Building Ground Floor, Dept of Palliative Medicine,Tata Memorial Hospital |
Dr. E. Borges Road
Parel
Mumbai 400012
Mumbai
MAHARASHTRA |
02224177000
jukd2000@yahoo.co.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, (2) ICD-10 Condition: C00-D49||Neoplasms, (3) ICD-10 Condition: C00-D49||Neoplasms, Patients with advanced cancer newly referred to palliative care services, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with advanced cancer newly referred to the palliative care services
2 Age 18-65
3 Outpatients
4 Patients able to give informed consent
5 Having an ability to communicate with the physician
6 ECOG performance status Grade 0, 1, 2
7 No previous history of psychotic illness
8 No current psychotic illness
9 No current cognitive deficits
|
|
| ExclusionCriteria |
| Details |
1 Age less than 18 years or above 65 years
2 Inpatients
3 ECOG performance status Grade 3, 4
4 Patients unable or unwilling to communicate with the physician
5 Past history of psychotic disorder
6 Current psychotic disorder
7 Patients with cognitive deficits
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of adult outpatients with advanced cancer newly referred to palliative care services meeting the ICD 10 criteria for Depressive episode or Recurrent depressive disorder |
Analysis at end of cross sectional study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of depressive disorder diagnosed as above with demographic , socioeconomic (socio-economic category, presence or absence of debt, presence/absence of perceived support) and clinical variables (site of cancer, presence/absence of past history of psychiatric illness, presence/absence of family history of psychiatric illness, pain and symptoms scores on Edmonton Symptom Assessment Scale) |
Analysis at end of cross sectional study |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/09/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of the study is to estimate the prevalence of depressive disorder in adult patients with advanced cancer referred to palliative care services, identify the severity of the depressive disorders and socio-demographi and clinical associated with depressive disorders in this group of patients.
We hypothesize that there will be a high rate of depressive disorder in adult patients with advanced cancer on palliative care and certain socio-demographic and clinical factors will affect the presence or absence and severity of depressive disorder in this group of patients.
|