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CTRI Number  CTRI/2025/02/080729 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Burden, and Quality of Life of the Informal Caregiver and Its Relationship with Distress, Depression, and Anxiety of Cancer Patients Undergoing Chemotherapy in a Tertiary Cancer Centre: A Comparative Cross-Sectional Study. 
Scientific Title of Study   Burden, and Quality of Life of the Informal Caregiver and Its Relationship with Distress, Depression, and Anxiety of Cancer Patients Undergoing Chemotherapy in a Tertiary Cancer Centre: A Comparative Cross-Sectional Study. 
Trial Acronym  CB Study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jisha Abraham 
Designation  Lecture, Psycho-Oncologist 
Affiliation  Malabar Cancer Centre 
Address  MALABAR CANCER CENTRE (POST GRADUATE INSTITUTE OF ONCOLOGY SCIENCES & RESEARCH), Moozhikkara (P.O), Thalassery, Kannur District, Kerala,India-670103

Kannur
KERALA
670103
India 
Phone  04902399268  
Fax    
Email  jishasarah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jisha Abraham 
Designation  Lecture, Psycho-Oncologist 
Affiliation  Malabar Cancer Centre 
Address  MALABAR CANCER CENTRE (POST GRADUATE INSTITUTE OF ONCOLOGY SCIENCES & RESEARCH), Moozhikkara (P.O), Thalassery, Kannur District, Kerala,India-670103

Kannur
KERALA
670103
India 
Phone  04902399268  
Fax    
Email  jishasarah@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Amritha Jacob 
Designation  Fellow in Psycho-oncology 
Affiliation  Malabar Cancer Centre 
Address  MALABAR CANCER CENTRE (POST GRADUATE INSTITUTE OF ONCOLOGY SCIENCES & RESEARCH), Moozhikkara (P.O), Thalassery, Kannur District, Kerala,India-670103

Kannur
KERALA
670103
India 
Phone  8129538108  
Fax    
Email  amrithamjacob@gmail.com  
 
Source of Monetary or Material Support  
Malabar Cancer Centre, Thalassery, Kannur, Kerala  
 
Primary Sponsor  
Name  Malabar Cancer Centre 
Address  Malabar Cancer Centre, Thalassery, Kannur Kerala  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Jisha Abraham   Malabar Cancer Centre   Division of Psycho-oncology, Malabar Cancer Centre, Kannur, Kerala
Kannur
KERALA 
04902399268

jishasarah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee, Malabar Cancer Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Informal caregivers of cancer patients 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion Criteria for Patients
1. Individuals diagnosed with a diagnosis of malignancy for one month at least and is undergoing chemotherapy at Malabar Cancer Centre as day care or inpatient.
2. Patient is aware of the diagnosis and treatment.
3. Patients who can read, write, and understand Malayalam or English.
4. Patients who are undergoing curative or first-line palliative intent treatment.
5. An informal caregiver is present with the patient as bystander during chemotherapy.
Inclusion Criteria for Caregivers
1. Informal caregiver is aware of the diagnosis and treatment.
2. Informal caregiver who can read, write, and understand English or Malayalam.
3. Informal caregiver is supporting the patient for atleast one month.
 
 
ExclusionCriteria 
Details  Exclusion Criteria:
1. Patient or informal caregiver with any known psychiatric or psychological conditions.
2.Patient or informal caregiver has not diagnosed with a neurological disorder, Alzheimer’s or brain tumour.
3. Patient or informal caregiver with a known history of sensory impairment or physical disabilities or Intellectual Disability.
Patient or informal caregiver with a history of alcohol or tobacco use for the last two weeks.
4.Patients with relapse/recurrence/second primary.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find the CB, and CQoL of the informal caregivers of the cancer patients undergoing chemotherapy in the hospital.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To find the relationship of CB, & CQoL of the informal caregivers with the distress, depression, & anxiety among cancer patients undergoing chemotherapy in the hospital.  baseline 
 
Target Sample Size   Total Sample Size="188"
Sample Size from India="188" 
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)   20/02/2025 
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="6"
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  

In India, research on caregiver burden remains limited. This study will explore caregiver burden, quality of life, and its relationship with distress, depression, anxiety, and stress among cancer patients undergoing chemotherapy.

The study aims to find the Caregiver Burden (CB), and Caregiver Quality of Life (CQoL) of the informal caregivers and its relationship with distress, depression, and anxiety among cancer patients undergoing chemotherapy in the hospital. The primary objective of the study is to find the CB, and CQoL of the informal caregivers of the cancer patients undergoing chemotherapy in the hospital. The study sample will consist of atleast 94 caregivers and their 94 patients who are undergoing chemotherapy at Malabar Cancer Centre between the age of 18 and 70.

The inclusion criteria for patients are individuals diagnosed with malignancy for at least one month, undergoing chemotherapy at Malabar Cancer Centre, aware of their diagnosis and treatment, able to read and understand Malayalam or English, undergoing curative or first-line palliative treatment, and accompanied by an informal caregiver during chemotherapy. For caregivers, the inclusion criteria are awareness of the patient’s diagnosis and treatment, proficiency in Malayalam or English, and providing support for at least one month. The exclusion criteria for both patients and caregivers include any known psychiatric or psychological conditions, neurological disorders, brain tumors, sensory impairments, physical or intellectual disabilities, or a recent history of alcohol or tobacco use. Additionally, patients with relapse, recurrence, or a second primary are excluded.

Data will be analyzed using SPSS version 29, with descriptive statistics (frequencies, percentages, mean, median, SD, range), t-tests, ANOVA, correlation, and Chi-square tests to assess relationships and associations between variables. If applicable, logistic regression will be used to estimate the impact of caregiver burden on the patient’s psychological outcomes.

 
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