| 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
|
|
|
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
|
|
|
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. |