跳至主要内容
临床试验/CTRI/2025/09/094049
CTRI/2025/09/094049尚未招募不适用

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

未提供1 个研究点 分布在 1 个国家目标入组 840 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
840
试验地点
1
主要终点
To perform translation of PCI-HN will be carried out in the native Indian population speaking Hindi, Marathi and Bengali.

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 89.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

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

时间窗: 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).

时间窗: 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.

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Sandeep Guarv

Tata Memorial Hospital

研究点 (1)

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