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CTRI Number  CTRI/2023/03/050624 [Registered on: 13/03/2023] Trial Registered Prospectively
Last Modified On: 06/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A cross-sectional study of burden of care and psychiatric disorder found in caregiver of patient diagnosed with cancer in private hospital setting 
Scientific Title of Study   A study of psychiatric morbidity and burden of care in caregivers of cancer patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vartika Mishra 
Designation  PG student 
Affiliation  PACIFIC MEDICAL COLLEGE AND HOSPITAL 
Address  room no 7, department of psychiatry PMCH campus, Bhillon ka bedla, Udaipur
department of psychiatry, Pacific medical college and hospital, bhillon ka bedla, udaipur
Udaipur
RAJASTHAN
313001
India 
Phone  9022564555  
Fax    
Email  vartikamishra503@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suresh kumar Mehta 
Designation  Professor and HOD, MD (psychiatry) 
Affiliation  PACIFIC MEDICAL COLLEGE AND HOSPITAL 
Address  room no 1, department of psychiatry, PMCH campus, Bhillon ka bedla, Udaipur
department of Psychiatry,Pacific medical college and hospital, bhillon ka bedla, udaipur
Udaipur
RAJASTHAN
313001
India 
Phone  9116476422  
Fax    
Email  drsureshmehta@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Vartika Mishra 
Designation  PG student 
Affiliation  PACIFIC MEDICAL COLLEGE AND HOSPITAL 
Address  room no 7, department of psychiatry, PMCH campus, Bhillon ka bedla, Udaipur
department of psychiatry, Pacific medical college and hospital, bhillon ka bedla, udaipur
Udaipur
RAJASTHAN
313001
India 
Phone  9022564555  
Fax    
Email  vartikamishra503@gmail.com  
 
Source of Monetary or Material Support  
Pacific medical college and hospital, bhillon ka bedla, udaipur, rajasthan 
 
Primary Sponsor  
Name  NONE 
Address  NONE 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NONE 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
VARTIKA MISHRA  pacific medical college and hospital  department of psychiatry, PMCH CAMPUS, BHILLON KA BEDLA, UDAIPUR, RAJASTHAN
Udaipur
RAJASTHAN 
9022564555

vartikamishra503@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Pacific Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Relatives of the cancer patients. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  •For cancer patients-
Patients attending Oncology and Onco surgery OPD/IPD
Having a histopathological diagnosis of cancer.
Who gave Consent to their care givers to participate in the study.

•For Caregivers-
Caregivers living together with the patient for minimum duration of 1 year.
Age group between 18 to 55 years, both genders
Who will give consent to participate in the study

 
 
ExclusionCriteria 
Details  For Patient-
Who did not give consent to their caregivers to participate in study.

For care givers-
Those who have a history of major psychiatric disorder (including substance use disorder).
History of significant head injury or major medical illness

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
burden of care  baseline 
 
Secondary Outcome  
Outcome  TimePoints 
psychiatric morbidity  baseline 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   15/03/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Expected outcome & Application Based on literature, significant burden of care and psychiatric morbidity is expected to be found in the study subjects, with co-relations between advanced stages of cancer and the psychological impact on caregivers. The most commonly detected morbidity is expected to be depression and anxiety. This study will help in diagnosing overt or covert psychological manifestations of caregiving in family members/ caregivers of cancer patients. Timely detection and interventions to address the same would amplify the quality of their caregiving role. Also, understanding the multifaceted nature of burden of care in caregivers will help in formulating the treatment plan for patients more comprehensively.

 Research question(s):  

What are the psychiatric morbidities experienced by care givers of cancer patients?

What is the perceived burden of caregiving in care givers of cancer patients?

Aim and objectives: 

  • To study Psychiatric morbidities in caregivers of cancer patients.
  • To assess the severity of depressive symptoms in caregivers of cancer patients.
  • To assess the severity of anxiety symptoms in caregivers of cancer patients.
  • To assess Burden of care in caregivers of cancer patients.
  • To study the correlation between caregiver burden and study variables.

 Inclusion criteria: 

  For cancer patients-

 

  Patients attending Oncology and Onco surgery OPD/IPD

  Having a histopathological diagnosis of cancer.

  Who gave Consent to their care givers to participate in the study.


 For Caregivers-

 Caregivers living together with the patient for minimum duration of 1 year.

Age group between 18 to 55 years, both genders

Who will give consent to participate in the study

Exclusion criteria: 

 For Patient-

 

 Who did not give consent to their caregivers to participate in study.


For care givers-

 

  Those who have a history of major psychiatric disorder (including  substance use disorder)

 History of significant head injury or major medical illness.



STUDY INSTRUMENTS:

 

 

1.     ZARIT BURDEN INTERVIEW – ZBI was developed to measure subjective burden amongst caregivers. Items were generated based on clinical experiences with caregiver and prior studies resulting in a 22- item self- report inventory, that examine the burden associated with functional/behavioural  impairment and the homecare situation. Each question is scored on a 5 point like scale ranging from- never to nearly always present. Total scores range from 0 to 88

 

2.     BECK’S ANXIETY INVENTORY-  BAI measures the common symptoms of anxiety and they ask the subject to define the presence,  absence and severity of their symptoms in last month. The 21 question on the inventory are scored on a scale value of 0-3 and score ranges from 0 to 63.

 

3.     BECK’S DEPRESSION INVENTORY- BDI is a 21 question multiple choice self report inventory, one of the most widely used instrument to measure the severity of depression. A value of 0-3 is assigned to each answer and score ranges from 0 to 63.

 

4.     DSM CROSS CUTTING LEVEL I AND II – The DSM 5  cross-cutting symptom measure is intended to help clinician identify additional area of inquiry that may have significant impact on individual treatment and prognosis. This adult version of measure consists of 23 questions that assess 13 psychiatric domains.

 

 

 

 
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