| 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
|
|
|
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
|
|
|
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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