AnxietyV-ANXIETYNCT07517458
The Assessment of Preoperative Anxiety in Cancer Patients: Validation, Observational, Descriptive Study.
An observational study of Anxiety, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 23 May 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with oncological pathology who will have to undergo surgery at IRCCS-CRO Aviano
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Diagnosis of cognitive dysfunction and psychiatric disorders, or uncooperative patient
- Difficulty in understanding the Italian language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
Aviano, Pordenone, 33081
Cristina Mazzega Fabbro, 0432 520922 ext. +39, cristina.mazzega@cro.it
Lucia Cadorin, PhD, 0434 659508 ext. +39, lcadorin@cro.it
About this 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.
Read more
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.
- Conditions
- Anxiety
- Medical subject headings
- Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: up to 1 year
To assess the reliability of the SAQ translation
Internal consistency will be measured with Cronbach alpha
Measured: 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
Measured: 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
Measured: 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
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start23 May 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517458
- Sponsor's protocol ID
- CRO-2023-118
- Acronym
- V-ANXIETY
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Preoperative Anxiety in Cancer Patients: Validation, Observational, Descriptive Study.
- ClinicalTrials.gov ID
- NCT07517458
- Acronym / sponsor ID
- V-ANXIETY / CRO-2023-118
- Conditions
- Anxiety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with oncological pathology who will have to undergo surgery at IRCCS-CRO Aviano
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 18 years
- Diagnosis of cognitive dysfunction and psychiatric disorders, or uncooperative patient
- Difficulty in understanding the Italian language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
To assess the reliability of the SAQ translation
Time frame: up to 1 year
Internal consistency will be measured with Cronbach alpha
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
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Mazzega Fabbro (0432 520922 ext. +39, cristina.mazzega@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the content validity of the SAQ translation (time frame: up to 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.