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CTRI Number  CTRI/2025/09/094049 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Making the Head and Neck Cancer-specific Patient Concerns Inventory (PCI-HN) available and reliable for patients who speak Hindi, Marathi, and Bengali. 
Scientific Title of Study   Translation and validation of Head and Neck cancer-specific Patient Concerns Inventory (PCI-HN) in Indian vernacular languages Hindi, Marathi and Bengali. 
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 Sandeep Guarv 
Designation  Professor  
Affiliation  Tata Memorial Hospital 
Address  Dental and Prosthetic Surgery, Tata Memorial Hospital, Dr. E. Borges Marg, Parel Mumbai -400012

Mumbai
MAHARASHTRA
400012
India 
Phone  919769387712  
Fax    
Email  drsandeepgurav@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Guarv 
Designation  Professor  
Affiliation  Tata Memorial Hospital 
Address  Dental and Prosthetic Surgery, Tata Memorial Hospital, Dr. E. Borges Marg, Parel Mumbai -400012

Mumbai
MAHARASHTRA
400012
India 
Phone  919769387712  
Fax    
Email  drsandeepgurav@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sandeep Guarv 
Designation  Professor  
Affiliation  Tata Memorial Hospital 
Address  Dental and Prosthetic Surgery, Tata Memorial Hospital, Dr. E. Borges Marg, Parel Mumbai -400012

Mumbai
MAHARASHTRA
400012
India 
Phone  919769387712  
Fax    
Email  drsandeepgurav@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr. Ernest Borges Rd, Parel East, Parel, Mumbai, Maharashtra 400012 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Sandeep Gurav  Tata Memorial Hospital  Dental and Prosthetic Surgery, Tata Memorial Hospital, Dr. E. Borges Marg, Parel Mumbai -400012
Mumbai
MAHARASHTRA 
9769387712

drsandeepgurav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  89.00 Year(s)
Gender  Both 
Details  All eligible consenting adult Head and neck cancer patients who have completed their curative treatment are on regular hospital follow-up.Disease free patients following head and neck cancer treatment, who are attending their routine clinic consultation.
Patients who can read, write and understand Hindi / Marathi/ Bengali language by themselves. 
 
ExclusionCriteria 
Details  Patients with cognitive impairment, psychiatric illness.Illiterate patients or visually impaired patients who cannot read by themselves.
Patients who have been treated for thyroid and skull-based cancers. (PCI-HN).Patients on any form of palliative treatment for head and neck cancer (PCI-HN). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To perform translation of PCI-HN will be carried out in the native Indian population speaking Hindi, Marathi and Bengali.
To test the translated version psychometrically through measures of statistical reliability (internal consistency and test-retest reliability).
To find association between demographic factors and PCI-HN domains. 
The translated PCI checklist will be given to each person just once, and their answers will be recorded on that day. There is no need for any follow-up visits afterwards 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="840"
Sample Size from India="840" 
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)   15/09/2025 
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="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  

Head and neck cancer (HNC) covers a group of cancers affecting areas like the mouth, throat, and sinuses. There has been significant progress in HNC treatment over the last few decades, resulting in improved survival rates. However, despite these advancements, individuals diagnosed and treated for HNC continue to deal with a variety of challenging issues, encompassing both psychosocial and physical domains. Unfortunately, these issues often remain unacknowledged and unmet. In this context, the Patient Concern Inventory (PCI) assumes a pivotal role. It serves as a means through which patients can articulate their unique needs, concerns, and preferences to their healthcare providers. It fosters a collaborative patient-clinician dialogue, ultimately aiming to improve shared decision-making and, consequently, patient outcomes. A challenge arises, however, in that the PCI is presently available only in English. Given the linguistic diversity of India, it is imperative to adapt and validate this instrument in Hindi, Marathi, and Bengali, rendering it accessible to a broader patient demographic. Thus, the purpose of our study is to undertake the translation and validation of the PCI for these Indian vernacular languages to make it available to clinicians and the scientific community who work with patients who speak Hindi, Marathi, or Bengali to be used in research and practice.

 
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