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CTRI Number  CTRI/2023/12/060895 [Registered on: 28/12/2023] Trial Registered Prospectively
Last Modified On: 01/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   Burden in caregivers of cancer patients undergoing radiotherapy  
Scientific Title of Study   Evaluation of the level of burden on caregivers of cancer patients undergoing radiotherapy: A prospective observational study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Santoshi Wadhwani 
Designation  Executive-Public Relation/ Patient Counsellor 
Affiliation  HCG NCHRI Cancer Centre , Nagpur 
Address  Room number 3, Psycho-oncology Department, Ground Floor, HCG NCHRI Cancer Centre, Khasra No. 50-51, Mouja Wanjari, Bande Nawaz Nagar, near Automotive Square, Kalmana Ring Road, Nagpur

Nagpur
MAHARASHTRA
440026
India 
Phone  7722037495  
Fax    
Email  santoshiwadhwani@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Santoshi Wadhwani 
Designation  Executive-Public Relation/ Patient Counsellor 
Affiliation  HCG NCHRI Cancer Centre , Nagpur 
Address  Room number 3, Psycho-oncology Department, Ground Floor, HCG NCHRI Cancer Centre, Khasra No. 50-51, Mouja Wanjari, Bande Nawaz Nagar, near Automotive Square, Kalmana Ring Road, Nagpur

Nagpur
MAHARASHTRA
440026
India 
Phone  7722037495  
Fax    
Email  santoshiwadhwani@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Santoshi Wadhwani 
Designation  Executive-Public Relation/ Patient Counsellor 
Affiliation  HCG NCHRI Cancer Centre , Nagpur 
Address  Room number 3, Psycho-oncology Department, Ground Floor, HCG NCHRI Cancer Centre, Khasra No. 50-51, Mouja Wanjari, Bande Nawaz Nagar, near Automotive Square, Kalmana Ring Road, Nagpur

Nagpur
MAHARASHTRA
440026
India 
Phone  7722037495  
Fax    
Email  santoshiwadhwani@yahoo.com  
 
Source of Monetary or Material Support  
HCG NCHRI Cancer Center, Nagpur 
 
Primary Sponsor  
Name  HCG NCHRI Cancer Centre  
Address  HCG NCHRI Cancer Centre, Khasra No. 50-51, Mouja Wanjari, Bande Nawaz Nagar, near Automotive Square , Kalmana Ring Road , Nagpur 
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 
Santoshi Wadhwani  HCG NCHRI Cancer Center  Khasra No.50,51, Mouja Wanjri Bande Nawaz Nagar,Near Automotive Square
Nagpur
MAHARASHTRA 
7722037495

santoshiwadhwani@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HCH NCHRI Cancer Center Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Caregivers all types of cancer patients , undergoing radiotherapy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Caregivers of cancer patients who have completed at least 15 radiotherapy fractions
 
 
ExclusionCriteria 
Details  Professional caregivers
Caregivers having psychiatric problems
Caregivers with dementia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of caregiver burden  15 days after starting radiotherapy of cancer patients 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="217"
Sample Size from India="217" 
Final Enrollment numbers achieved (Total)= "217"
Final Enrollment numbers achieved (India)="217" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/01/2024 
Date of Study Completion (India) 13/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  


Introduction:

Cancer patients undergoing radiotherapy often require assistance from family caregivers during and after the treatment. Radiotherapy is time-consuming for cancer patients and their caregivers, requiring multiple hospital visits and it is often supplemented with additional treatments such as chemotherapy. It has been observed that caregivers of cancer patients undergoing radiotherapy experience consistently elevated caregiver burden. [1]

Self-care deficit, sleep disturbance, psychosocial pressures, stress, fatigue, exhaustion, and intensification of depressive and anxious symptoms are identified in family caregivers during radiotherapy.[2] The physical, emotional, and social burden on caregivers may adversely affect their personal lives and lead to emotional instabilities [3] and poor quality of life. [4]

Caregiving for cancer patients creates physical and psychological chronic stress over an extended period. The associated unpredictability and uncontrollability can affect multiple life domains and frequently require high levels of vigilance. The caregiving burden is predominantly overwhelming, particularly in developing countries [5] and those with lower socioeconomic status. [1] Therefore, in the Indian context, there is a need for a better understanding of the psychosocial difficulties caregivers face. Assessing the caregiver burden is critical, as it has implications for their quality of life, physical health, and ability to provide ongoing care to the patient. Identifying the caregiver burden is the first step in planning appropriate interventions designed to address their unmet needs and enhance their psychological well-being.

In vew of this, the present study is undertaken for evaluation of the level of burden on caregivers of cancer patients undergoing radiotherapy at HCG NCHRI Cancer Center, Nagpur.

Objectives:

1. To evaluate the level of burden on caregivers of cancer patients undergoing radiotherapy as measured by Zarit Burden Interview -22.

2. To identify the association of variables like the patient’s type of cancer, caregivers’ age, gender, education, occupation, economic status, and perceived social support with caregiver burden.

Study hypothesis:

Caregivers of cancer patients undergoing radiotherapy would be experiencing significant caregiver burden.

Methodology:

The concept of the study will be explained to the caregivers of cancer patients undergoing radiotherapy. Signatures of eligible caregivers who are willing to participate in the study will be obtained on written informed consent forms. The caregivers’ responses will be recorded by the interview technique by a clinical psychologist. The data collection will take place after the completion of 15 radiotherapy fractions. One primary caregiver of the patients will be assessed.

 

Measures:

Demographic details of the caregivers:

Medical history of the patient

Zarit Burden Interview-22 (ZBI-22)

The Multidimensional Scale of Perceived Social Support (MSPSS)


References:

1. Mutsaers A, Pritchard A, Boldt G, Laba JM. Caregiver Burden for Informal Careers of Patients Undergoing Radiotherapy for Malignancy: A Systematic Review. International Journal of Radiation Oncology, Biology, Physics. 2019 Sep 1;105(1):E603.

2. Pedrosa AO, Rocha DM, Oliveira AC de, Benício CDAV, Ribeiro ÍAP, Nogueira LT. Factors associated with overload in family caregivers in radiotherapy. J Nurs UFPE on line. 2019;13:e241472 DOI: https://doi.org/10.5205/1981- 8963.2019.241472

3. Pedrosa AD, Rocha DD, Oliveira AC, Santos AM, Figueiredo MD, Nogueira LT. Indicators and factors associated with burden in informal caregivers of patients undergoing radiotherapy. Acta Paulista de Enfermagem. 2021 Nov 26;34.

4. Sanjeevani, G., Ramakanth, P., Chaitanya, A. (2022). A cross-sectional study of psychopathology, quality of life and caregiver burden in caregivers of cancer patients. ScienceRise: Medical Science, 5 (50), 57–64. doi: http://doi.org/10.15587/2519-4798.2022.265395

5. Schulz R, Sherwood PR. Physical and mental health effects of family caregiving. Journal of Social Work Education. 2008 Sep 1;44(sup3):105-13.


 
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