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临床试验/NCT04773379
NCT04773379已完成不适用

Validation of the Patient Neurotoxicity Questionnaire for Patients Suffering From Chemotherapy Induced Peripheral Neuropathy in Greek.

Democritus University of Thrace1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年4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
100
试验地点
1
主要终点
Change from baseline in CIPN symptoms on the PNQ at the 2nd chemotherapy treatment session.

研究概览

简要总结

The Patient Neurotoxicity Questionnaire (PNQ) represents a diagnostic tool concerning patients with Chemotherapy Induced Peripheral Neuropathy (CIPN). Application of such a tool in the Greek clinical praxis requires validation.

Validation consists of three stages: translation, reverse translation, and patient application. 100 oncologic patients were assessed by comparing the PNQ to the NCI-CTCAE at the chemotherapy onset and 2nd, 4th, and 6th sessions. Specific requirements of the diagnostic tool (compliance, validity, concordance, sensitivity, specificity, reliability) were statistically evaluated.

Differences between translated texts and between the reverse translation and the original were considered negligible. At the 2nd, 4th and 6th session compliance was 98%, 95% and 93% while Cronbach's α was 0,57 0,69 and 0,81 respectively. Cohen's weighted κ was 0,67 and 0,58, Spearman's ρ was 0,7 and 0,98 while AUC of the ROC was 1 and 0,9 for the sensory and the motor part respectively. The variance's linear regression analysis confirmed CIPN worsening over time (p-value<0,0001).

The Greek version remains close to the original. Compliance rates reflect easy PNQ application. Cohen's κ values highlight the physicians' tension to underestimate the patients' condition. Spearman's ρ, Cronbach's α and AUC values reflect good validity, reliability and specificity of the PNQ respectively. Finally, the linear analysis confirmed the PNQ sensitivity over time.

The PNQ validation in Greek adds a crucial tool in the physicians' armory. It can now draw the necessary information to modify the chemotherapy and analgesic treatment schemes at both preventive and acute levels.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 and under 80 years of age
  • Patients that undergo chemotherapy for the first time
  • Patients regardless of cancer type
  • Patients regardless of social and education underground
  • Patients able to communicate with personnel

排除标准

  • Pediatric patients
  • Preexisting neurological condition
  • Patients already under chemotherapy treatment
  • Patients unable to communicate with personnel

结局指标

主要结局

Change from baseline in CIPN symptoms on the PNQ at the 2nd chemotherapy treatment session.

时间窗: Baseline (1st chemotherapy treatment session) and up to 1 month (2nd chemotherapy treatment session).

The PNQ is a self reported instrument assessing CIPN symptoms (sensory and motor) over time. Possible scores range from A(none) to E(severe).

Change from the 4th chemotherapy treatment session in CIPN symptoms on the PNQ at the 6th chemotherapy treatment session.

时间窗: 4th chemotherapy treatment session and up to 2 months (6th chemotherapy treatment session).

The PNQ is a self reported instrument assessing CIPN symptoms (sensory and motor) over time. Possible scores range from A(none) to E(severe).

Change from the 2nd chemotherapy treatment session in CIPN symptoms on the PNQ at the 4th chemotherapy treatment session.

时间窗: 2nd chemotherapy treatment session and up to 2 months (4th chemotherapy treatment session).

The PNQ is a self reported instrument assessing CIPN symptoms (sensory and motor) over time. Possible scores range from A(none) to E(severe).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Theofilos Tsoleridis

Principal Investigator

Democritus University of Thrace

研究点 (1)

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