The Assessment of Preoperative Anxiety in Cancer Patients: Validation, Observational, Descriptive Study.
V-ANXIETY
1 other identifier
observational
180
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2024
CompletedFirst Submitted
Initial submission to the registry
March 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedFirst Posted
Study publicly available on registry
April 8, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedApril 8, 2026
April 1, 2026
1.9 years
March 20, 2026
April 1, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (1)
Measuring the level of preoperative anxiety in patients undergoing surgery at the Centro di Oncology Reference Center-IRCCS of Aviano (IRCCSCRO Aviano)
up to 1 year
Eligibility Criteria
Patients with oncological pathology who will have to undergo surgery at IRCCS-CRO Aviano
You may qualify if:
- 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
You may not qualify if:
- Age \< 18 years
- Diagnosis of cognitive dysfunction and psychiatric disorders, or uncooperative patient
- Difficulty in understanding the Italian language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
Aviano, Pordenone, 33081, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2026
First Posted
April 8, 2026
Study Start
May 23, 2024
Primary Completion
April 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 8, 2026
Record last verified: 2026-04