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临床试验/CTRI/2026/01/101489
CTRI/2026/01/101489尚未招募不适用

Implementation of Patient-Reported Outcome Measures (PROMs) in Patients Undergoing Oral Cancer Surgery

Tata Memorial Centre Research Administration Council1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1

研究概览

简要总结

India has the highest number of oral cancer cases worldwide, accounting for one-third of the global total. Though better surgical and chemo-radiation protocols have improved disease related outcomes, the debilitating effect of these therapeutic interventions continue to have a negative impact on the patients’ quality of life (QoL) , in terms of altered taste and mastication, swallowing and speech impairment, cosmetic disfigurement, restricted mouth opening, mucositis, weight loss, cachexia, depression and anxiety

Symptom monitoring via patient-reported outcome measures (PROMs) offers an evidence-based approach to detecting symptoms which can provide critical information to clinicians, thereby improving clinical management. PROMs can also be used to foster communication between patients and clinicians, help facilitate an optimal rehabilitative program and improve QoL.

Problem Statement – What we cannot assess, we cannot address.

PROMs are currently being recorded only for patients enrolled in clinical trials at our tertiary cancer centre in Muzaffarpur, Bihar. Early identification of the major concerns our patients are facing through PROMs might improve patient -clinician communication and allow us to provide multidisciplinary interventions if indicated. However, integration of PROMs into our existing system will be resource intensive and may cause additional stress on both patients and clinicians. Therefore, it is essential to establish that all invested partners are on board before implementing the same.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients with histologically proven oral squamous cell carcinoma, with plans for surgery with or without adjuvant therapy for oral cancer.
  • Patients will be enrolled within a month of diagnosis, and the first PROM will be assessed the night before surgery.

排除标准

  • Patients with cognitive impairments to whom the content of questionnaires cannot be adequately explained.

研究者

发起方
Tata Memorial Centre Research Administration Council
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Burhanuddin Qayyumi

Homi Bhabha Cancer Hospital and Research Centre

研究点 (1)

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