The Assessment of Preoperative Anxiety in Cancer Patients: Validation, Observational, Descriptive Study. (V-ANXIETY)

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Cristina Mazzega Fabbro; Phone Number: +39 0432 520922; Email: cristina.mazzega@cro.it
• Study Contact Backup: Name: Lucia Cadorin, PhD; Phone Number: +39 0434 659508; Email: lcadorin@cro.it

Study Locations

• Italy
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Recruiting
      • Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
      • Principal Investigator: Lucia Cadorin, PhD
      • Contact: Cristina Mazzega Fabbro; Phone Number: +39 0432 520922; Email: cristina.mazzega@cro.it
      • Contact: Lucia Cadorin, PhD; Phone Number: +39 0434 659508; Email: lcadorin@cro.it
      • Principal Investigator: Cristina Mazzega Fabbro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with oncological pathology who will have to undergo surgery at IRCCS-CRO Aviano

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the content validity of the SAQ translation	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	up to 1 year
To assess criterion validity of the SAQ translation	Criterion validity will be assessed by calculating the correlation between the translated SAQ total score and a validated Hamilton Rating for Anxiety (HAM-A)	up to 1 year
To assess the reliability of the SAQ translation	Internal consistency will be measured with Cronbach alpha	up to 1 year
To assess the construct validity of the SAQ translation	Confirmatory Factor Analysis will be carried out to assess construct validity. Factor loadings, eigenvalues and explained variance will be reported	up to 1 year
To assess the construct validity of the SAQ translation	Exploratory Factor Analysis will be carried out to assess construct validity. Factor loadings, eigenvalues and explained variance will be reported	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring the level of preoperative anxiety in patients undergoing surgery at the Centro di Oncology Reference Center-IRCCS of Aviano (IRCCSCRO Aviano)	Level of preoperative anxiety will be measured with the validated SAQ questionnaire. Score will be reported as mean and standard deviation. The score range is 17-85, with higher scores indicating worst anxiety	up to 1 year

Collaborators and Investigators

• Sponsor: Centro di Riferimento Oncologico - Aviano

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: CRO-2023-118

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No