| 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
|
|
|
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
|
|
|
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. |