Skip to main content
Clinical Trials/CTRI/2025/09/094049
CTRI/2025/09/094049
Not yet recruiting
Not Applicable

Translation and validation of Head and Neck cancer-specific Patient Concerns Inventory (PCI-HN) in Indian vernacular languages Hindi, Marathi and Bengali.

Not provided1 site in 1 country840 target enrollmentStarted: September 15, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
840
Locations
1
Primary Endpoint
To perform translation of PCI-HN will be carried out in the native Indian population speaking Hindi, Marathi and Bengali.

Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 89.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

To perform translation of PCI-HN will be carried out in the native Indian population speaking Hindi, Marathi and Bengali.

Time Frame: 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

To test the translated version psychometrically through measures of statistical reliability (internal consistency and test-retest reliability).

Time Frame: 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

To find association between demographic factors and PCI-HN domains.

Time Frame: 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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
Not provided
Responsible Party
Principal Investigator
Principal Investigator

Dr Sandeep Guarv

Tata Memorial Hospital

Study Sites (1)

Loading locations...

Similar Trials