Clinical trial NCT04773379: Validation of the PNQ for CIPN Patients.
Official title: Validation of the Patient Neurotoxicity Questionnaire for Patients Suffering From Chemotherapy Induced Peripheral Neuropathy in Greek.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: chemotherapy
peripheral neuropathy
questionnaire
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 100 male or female patients from the oncology clinic of the General Hospital of Rhodes, Greece, regardless of cancer type

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in CIPN symptoms on the PNQ at the 2nd chemotherapy treatment session.
timeFrame: Baseline (1st chemotherapy treatment session) and up to 1 month (2nd chemotherapy treatment session).
measure: Change from the 2nd chemotherapy treatment session in CIPN symptoms on the PNQ at the 4th chemotherapy treatment session.
timeFrame: 2nd chemotherapy treatment session and up to 2 months (4th chemotherapy treatment session).
measure: Change from the 4th chemotherapy treatment session in CIPN symptoms on the PNQ at the 6th chemotherapy treatment session.
timeFrame: 4th chemotherapy treatment session and up to 2 months (6th chemotherapy treatment session).
Secondary outcomes:
Other outcomes:
Locations:
city: Rhodes
country: Greece
facility: General Hospital of Rhodes
state: Dodekanese
Study officials:
References: