The Assessment of Preoperative Anxiety in Cancer Patients: Validation, Observational, Descriptive Study.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Anxiety. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- To assess the content validity of the SAQ translation [Time frame: up to 1 year]
- To assess criterion validity of the SAQ translation [Time frame: up to 1 year]
- To assess the reliability of the SAQ translation [Time frame: up to 1 year]
- To assess the construct validity of the SAQ translation [Time frame: up to 1 year]
- To assess the construct validity of the SAQ translation [Time frame: up to 1 year]
Secondary outcome measures (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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS — Aviano
Identifiers
NCT: NCT07517458 · CRO-2023-118