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NCT Number: NCT07517458

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Aviano, Pordenone, 33081, Italy

Location status: Recruiting

Location contact

Cristina Mazzega Fabbro

CONTACT

[email protected]

0432 520922 ext. +39

Cristina Mazzega Fabbro

PRINCIPAL_INVESTIGATOR

Lucia Cadorin, PhD

CONTACT

[email protected]

0434 659508 ext. +39

Lucia Cadorin, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To assess the content validity of the SAQ translation

    Time frame: 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

  2. To assess criterion validity of the SAQ translation

    Time frame: 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)

  3. To assess the reliability of the SAQ translation

    Time frame: up to 1 year

    Internal consistency will be measured with Cronbach alpha

  4. To assess the construct validity of the SAQ translation

    Time frame: up to 1 year

    Confirmatory Factor Analysis will be carried out to assess construct validity. Factor loadings, eigenvalues and explained variance will be reported

  5. To assess the construct validity of the SAQ translation

    Time frame: up to 1 year

    Exploratory Factor Analysis will be carried out to assess construct validity. Factor loadings, eigenvalues and explained variance will be reported

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)

    Time frame: up to 1 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Mazzega Fabbro

CONTACT

[email protected]

0432 520922 ext. +39

Lucia Cadorin, PhD

CONTACT

[email protected]

0434 659508 ext. +39

Sponsors and collaborators

Lead sponsor

Centro di Riferimento Oncologico - Aviano

Other

Registry information

Acronym: V-ANXIETY

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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