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临床试验/NCT06457594
NCT06457594已完成不适用

Prospective Cohort Analysis - the Role of General and Specific Patient Reported Outcome and Experience Measures Among Head and Neck Cancer Patients

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Questionnaire scores

研究概览

简要总结

Importance:

Patient reported outcome and experience measures (PROM and PREM) constitute a cornerstone of the collective efforts to improve and personalize healthcare systems. The EORTC quality of life (QOL) group developed instruments evaluating general and disease specific oncology QOL questionnaires, and the quality of information received. Implementation of PREM and relevant PROM is essential for equity, better resources utility, accessibility and patient centered treatment.

Objectives:

The investigators describe the EORTC INFO 25 translation process followed by investigation of subpopulation where action is most needed. The investigators investigate which QOL questionnaire better reflects clinical parameters among head and neck cancer (HNC) patients.

Design:

A prospective cohort. Setting Tertiary, referral, head and neck dedicated surgical service.

Participants:

Consecutive head and neck cancer adult patients, surgically treated, recruited between January to December 2022.

Exposures:

The investigators prospectively analyzed the new EORTC INFO 25 Hebrew questionnaire together with previously established Arabic translated version and the general (QLQ-C30) and specific (QLQ - H&N43) oncology QOL questionnaires.

Main Outcomes and Measures:

Analyzing the quality of information provided and desired in diverse HNC subgroup of patients.

Analyzing which of PROM questionnaire better reflects HNC patients' disease and treatment parameters, which in turn, may predict poorer QOL.

Results:

The investigators recruited 60 patients, consisting of equal female: male ratio, of which 16.66% were native Arabic speaking. Validated INFO 25 scores (median 62.6±17.5) were not associated with patients' age, sex, education status, disease, and treatment parameters. Yet, the Arabic spoken sub-population had significantly lower scores (p<0.001).

In contrast to QLQ-C30, clinical imperative associations were demonstrated between QLQ - H&N43 and patients' disease stage (P<0.001), admission days (p<0.0001), free flap reconstruction (P<0.001) and adjuvant radiotherapy (P<0.001).

Conclusions and relevance:

The final version of the native EORTC INFO25 translation was approved by the EORTC. The investigators demonstrate lower INFO25 scores among the Arabic speaking population, suggesting frail equity and accessibility. In order to improve patients' centered treatment and resource utilization, the investigators reveal a strong association between disease severity and treatment aggressiveness and poor quality of life on specific, HNC oriented, EORTC QLQ - H&N43 questionnaire that was not validated on EORTC QLQ-C30, which can be omitted.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Questionnaire scores

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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