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CTRI Number  CTRI/2025/11/097301 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 12/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of Psychological Distress in Cancer patients undergoing surgery using Distress Thermometer 
Scientific Title of Study   Assessment of Psychological Distress in patients undergoing Oncological surgeries using Distress Thermometer 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhijeet Rathore 
Designation  Junior Resident 
Affiliation  Command Hospital, Lucknow 
Address  Department of Surgery, Command Hospital, Cantonment Rd, Sadar Bazaar, Cantonment, Lucknow

Lucknow
UTTAR PRADESH
226002
India 
Phone  09001640007  
Fax    
Email  abhi.doc.007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr R Saranga Bharathi  
Designation  Professor  
Affiliation  Command Hospital, Lucknow 
Address  Department of Surgery, Command Hospital, Cantonment Rd, Sadar Bazaar, Cantonment, Lucknow

Lucknow
UTTAR PRADESH
226002
India 
Phone  08554061554  
Fax    
Email  sarangabharathi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr R Saranga Bharathi  
Designation  Professor 
Affiliation  Command Hospital, Lucknow 
Address  Department of Surgery, Command Hospital, Cantonment Rd, Sadar Bazaar, Cantonment, Lucknow


UTTAR PRADESH
226002
India 
Phone  08554061554  
Fax    
Email  sarangabharathi@gmail.com  
 
Source of Monetary or Material Support  
Command Hospital, Lucknow  
 
Primary Sponsor  
Name  Dr Abhijeet Rathore 
Address  Command Hospital,Cantonment Rd, Sadar Bazaar, Cantonment, Lucknow, Uttar Pradesh 226002  
Type of Sponsor  Other [Self] 
 
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 Abhijeet Rathore  Command Hospital  Cantonment Rd, Sadar Bazaar, Cantonment, Lucknow
Lucknow
UTTAR PRADESH 
09001640007

abhi.doc.007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Command Hospital Central Command Lucknow  Approved 
Institutional Ethics Committee Command Hospital Central Command Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (2) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (3) ICD-10 Condition: C050||Malignant neoplasm of hard palate, (4) ICD-10 Condition: C021||Malignant neoplasm of border of tongue, (5) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, (6) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, (7) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (8) ICD-10 Condition: C20||Malignant neoplasm of rectum, (9) ICD-10 Condition: C218||Malignant neoplasm of overlappingsites of rectum, anus and anal canal, (10) ICD-10 Condition: C220||Liver cell carcinoma, (11) ICD-10 Condition: C250||Malignant neoplasm of head of pancreas, (12) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (13) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, (14) ICD-10 Condition: C472||Malignant neoplasm of peripheral nerves of lower limb, including hip, (15) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, (16) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (17) ICD-10 Condition: C649||Malignant neoplasm of unspecifiedkidney, except renal pelvis, (18) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified, (19) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (20) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, (21) ICD-10 Condition: C482||Malignant neoplasm of peritoneum,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients of newly diagnosed malignancies including pediatric patients capable of responding to DT. 
 
ExclusionCriteria 
Details  1.Patients previously diagnosed as a case of Psychiatric illness.
2.Patients with metastatic disease.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To screen out patients with high psychological distress (DT score 4 or more), and provide them appropriate psychological support.  02 years (Jan 2024 – Dec 2025) 
 
Secondary Outcome  
Outcome  TimePoints 
To use and validate DT for assessment of psychological distress in first-degree caregivers  02 years (Jan 2024 – Dec 2025) 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   30/11/2025 
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="1"
Months="0"
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  

1.   Psychological distress is well known in patients undergoing oncological surgeries for gastro-intestinal, urological, head and neck, gynecological, neurological (CNS tumors) malignancies and other cancers like breast cancer, skin cancer like malignant melanoma. It adversely affects the quality of life and cancer care. Distress is associated with depression, anxiety, missed appointments, and adverse outcomes. The NCCN distress thermometer (DT) is a validated tool for its assessment. However, the same has not been documented much in Indian population. This study aims to fulfill the above paucity. The DT is a one-item,11-point Likert scale represented on a visual graphic of a thermometer that ranges from 0 (no distress) to 10 (extreme distress). Patients are asked to indicate the number that best describes how much distress they have experienced over the past week, on a scale of 0 to 10. Further patients are prompted to choose problems which are causing them distress from the NCCN Problem list depicted on the right side of the tool. The NCCN Problem List for patients is a 43 - item supplemental list of potential sources of distress including physical, emotional, practical, social problems as well as spiritual/religious concerns. The established cutoff score for further screening is a 4.  Patients with a score of 4 or more, needs to be referred for further evaluation and management. Referrals can include psychologists, religious counsellors, and social workers.

 
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