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Recruiting Observational

The Assessment of Preoperative Anxiety in Cancer Patients: Validation, Observational, Descriptive Study.

NCT07517458 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-05-23
Last updated
2026-04-08

Condition(s) studied

Anxiety

Study summary

The study stems from the need to have available effective tools for detecting the anxiety of the cancer patient who has to undergo surgery.

The period leading up to surgery, is characterized by strong emotions that create an upheaval in the work, family and social life of the patient as well as concern about the unknown.

It would be crucial to ensure a personalized nursing care by having scales of assessment specific to the clinical-surgical oncology setting in order to collect the patient's emotions, concerns and fears.

Despite the numerous scales available, many of them have limitations concerning the issues they go to investigate but also concerning the timeframes for compilation, which are often long and laborious so they are difficult to apply.

The study aims to validate in the Italian context the Surgical Anxiety Questionnaire (SAQ) questionnaire, already translated and validated in multiple languages, to detect which factors are the most influential in increasing preoperative anxiety, with the aim of implementing education of the patient and implement strategies and interventions that can reduce anxiety.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * In ordinary hospitalization, day surgery, day hospital * Age ≥ 18 years * Signature of consent participation in the study and personal data collection and processing * Good understanding of the Italian language Exclusion Criteria: * Age \< 18 years * Diagnosis of cognitive dysfunction and psychiatric disorders, or uncooperative patient * Difficulty in understanding the Italian language

Primary outcome measure(s)

  • To assess the content validity of the SAQ translation — up to 1 year
    The content validity will be assessed by a panel of 5 experts and rated on a Content Validity Index (CVI). A CVI score \>=0.78 will indicate excellent content validity
  • To assess criterion validity of the SAQ translation — up to 1 year
    Criterion validity will be assessed by calculating the correlation between the translated SAQ total score and a validated Hamilton Rating for Anxiety (HAM-A)
  • To assess the reliability of the SAQ translation — up to 1 year
    Internal consistency will be measured with Cronbach alpha
  • To assess the construct validity of the SAQ translation — up to 1 year
    Confirmatory Factor Analysis will be carried out to assess construct validity. Factor loadings, eigenvalues and explained variance will be reported
  • To assess the construct validity of the SAQ translation — up to 1 year
    Exploratory Factor Analysis will be carried out to assess construct validity. Factor loadings, eigenvalues and explained variance will be reported

Trial sites (1)

FacilityCityRegionStatus
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS Aviano Pordenone Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07517458 on ClinicalTrials.gov ↗ ← All trials in Italy