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Validation of the PNQ for CIPN Patients.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04773379
Enrollment
100
Registered
2021-02-26
Start date
2019-04-01
Completion date
2020-10-31
Last updated
2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

chemotherapy, peripheral neuropathy, questionnaire

Brief 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.

Interventions

None listed

Sponsors

Democritus University of Thrace
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in CIPN symptoms on the PNQ at the 2nd chemotherapy treatment session.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 2nd chemotherapy treatment session in CIPN symptoms on the PNQ at the 4th chemotherapy treatment session.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).
Change from the 4th chemotherapy treatment session in CIPN symptoms on the PNQ at the 6th chemotherapy treatment session.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).

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026