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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07517458
Acronym
V-ANXIETY
Enrollment
180
Registered
2026-04-08
Start date
2024-05-23
Completion date
2026-12-01
Last updated
2026-04-08

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

Conditions

Anxiety

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.

Interventions

None listed

Sponsors

Centro di Riferimento Oncologico - Aviano
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
To assess the content validity of the SAQ translationup to 1 yearThe 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 translationup to 1 yearCriterion 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 translationup to 1 yearInternal consistency will be measured with Cronbach alpha
To assess the construct validity of the SAQ translationup to 1 yearConfirmatory Factor Analysis will be carried out to assess construct validity. Factor loadings, eigenvalues and explained variance will be reported

Secondary

MeasureTime frameDescription
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 yearLevel 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

Countries

Italy

Contacts

CONTACTCristina Mazzega Fabbro
cristina.mazzega@cro.it0432 520922
CONTACTLucia Cadorin, PhD
lcadorin@cro.it0434 659508

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026