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CTRI Number  CTRI/2025/10/096439 [Registered on: 24/10/2025] Trial Registered Prospectively
Last Modified On: 23/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Understanding Psychological Stress and Financial Challenges Faced by Cancer Patients During Radiotherapy 
Scientific Title of Study   Impact of Psychological Distress Among Cancer Patients Receiving 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  Kumud M Bongale 
Designation  Post Graduate Student, Department of Pharmacy Practice 
Affiliation  KLE College of Pharmacy, Belagavi  
Address  KLE College of Pharmacy, 4th Floor Room No.15, JNMC CAMPUS, Nehru Nagar, Belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9689090977  
Fax    
Email  kumudbongale@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manjula G 
Designation  Assistant Professor 
Affiliation  KLE College of Pharmacy, Belagavi 
Address  KLE College of Pharmacy, 4th Floor Room No.15, JNMC CAMPUS, Nehru Nagar, Belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  7204551475  
Fax    
Email  manjulag@klepharm.edu  
 
Details of Contact Person
Public Query  
Name  Kumud M Bongale 
Designation  Post Graduate Student, Department of Pharmacy Practice 
Affiliation  KLE College of Pharmacy, Belagavi  
Address  KLE College of Pharmacy, 4th Floor Room No.15, JNMC CAMPUS, Nehru Nagar, Belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9689090977  
Fax    
Email  kumudbongale@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  KLE College Of Pharmacy, Belagavi 
Address  JNMC CAMPUS, Nehru Nagar, Belagavi, Karnataka 590010 
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 
Dr Manjula G  KLEs Cancer Hospital, Belagavi  Consultation room 2,Radiotherapy department, G-2 floor, Azam Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA 		 7204551475

manjulag@klepharm.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLECOPBGM ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
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  90.00 Year(s)
Gender  Both 
Details  1.Patients with the age greater then or equal to 18 years and confirmed with cancer.
2.All individuals who were undergoing Radiation Therapy.
3.Patients who are inpatient and outpatients Department are included in this
study  
 
ExclusionCriteria 
Details  1.The patient who are not treated with Radiation Therapy.
2.All patients previously diagnosed with psychiatric condition were excluded
from the study.
3.Patient who are not willing to give Consent are excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To develop and validate a novel scale CaPSY-D for the assessment of psychological distress among cancer patients undergoing radiotherapy.
2.To identify the factors precipitating psychological distress among cancer patients undergoing radiotherapy. 		 Data will be collected once at the completion of radiotherapy (post-radiotherapy stage) approximately after 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To Develop & Validate the scale Life Cost Scale for assessment of Financial
Burden.  		 Data will be collected once at the completion of radiotherapy (post-radiotherapy stage) approximately after 4 weeks 
To assess the level of financial burden experienced by cancer patients
receiving radiotherapy.  		 Data will be collected once at the completion of radiotherapy (post-radiotherapy stage) approximately after 4 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   05/11/2025 
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="7"
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  

This is a cross-sectional, observational study conducted among cancer patients who have completed radiotherapy. The study aims to assess the level of psychological distress and financial toxicity using a newly developed and validated questionnaire designed specifically for this population. Patients will be enrolled at the end of radiotherapy, and data will be collected through direct interviews using the structured scale. The study findings are expected to provide insights into the association between financial burden and psychological well-being, thereby supporting the development of targeted interventions to improve quality of life in cancer patients receiving radiotherapy.

 
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