Validation of the PNQ for CIPN Patients.

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773379
• Other study ID #: DUThrace
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: February 2021
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pediatric patients

• Preexisting neurological condition

• Patients already under chemotherapy treatment

• Patients unable to communicate with personnel

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
Greece	General Hospital of Rhodes	Rhodes	Dodekanese

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in CIPN symptoms on the PNQ at the 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).	Baseline (1st chemotherapy treatment session) and up to 1 month (2nd chemotherapy treatment session).
Primary	Change from the 2nd chemotherapy treatment session in CIPN symptoms on the PNQ at the 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).	2nd chemotherapy treatment session and up to 2 months (4th chemotherapy treatment session).
Primary	Change from the 4th chemotherapy treatment session in CIPN symptoms on the PNQ at the 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).	4th chemotherapy treatment session and up to 2 months (6th chemotherapy treatment session).