ClinicalTrials.gg
RecruitingNCT07517458V-ANXIETYUpdated Apr 8, 2026

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

An observational study in Anxiety, sponsored by Centro di Riferimento Oncologico - Aviano. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Centro di Riferimento Oncologico - Aviano · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
18 Years and older
Sex
All
01

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.

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Conditions studied

  • Anxiety

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03

In context

Anxiety Disorders Unverified

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's planned enrollment of 180 is close to the median of 168 across 977 observational studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Centro di Riferimento Oncologico - Aviano is the lead sponsor of 51 studies on the registry; 36 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Age \< 18 years
  • Diagnosis of cognitive dysfunction and psychiatric disorders, or uncooperative patient
  • Difficulty in understanding the Italian language
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 1 year

  2. 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)

    Time frame: up to 1 year

  3. To assess the reliability of the SAQ translation

    Internal consistency will be measured with Cronbach alpha

    Time frame: up to 1 year

  4. 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

    Time frame: up to 1 year

  5. 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

    Time frame: 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)

    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

    Time frame: up to 1 year

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Study locations

1 of 1 sites recruiting
  • Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
    Aviano, Pordenone 33081, Italy
    Recruiting
    • Cristina Mazzega Fabbro · Contactcristina.mazzega@cro.it · 0432 520922
    • Lucia Cadorin, PhD · Contactlcadorin@cro.it · 0434 659508
    • Cristina Mazzega Fabbro · Principal investigator
    • Lucia Cadorin, PhD · Principal investigator
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07517458
Lead sponsor
Centro di Riferimento Oncologico - Aviano
Responsible party
Sponsor
First posted
Apr 8, 2026
Start date
May 23, 2024
Primary completion
Apr 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Apr 8, 2026

Study contacts

Cristina Mazzega Fabbro
Contact
cristina.mazzega@cro.it
0432 520922 ext. +39
Lucia Cadorin, PhD
Contact
lcadorin@cro.it
0434 659508 ext. +39

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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