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Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4): Italian version validation.

O Di Bella1, R A Cocchiara1, A De Luca2

  • 1Department of Public Health and Infectious Diseases, Sapienza University, Rome.

La Clinica Terapeutica
|August 29, 2018
PubMed
Summary

This study confirms that the Italian version of the FACT-B+4 questionnaire is a reliable and consistent tool for measuring the quality of life in breast cancer patients, matching the performance of versions in other languages.

Keywords:
Breast cancerFACT-BQuality of LifeQuestionnaireValidationpsychometric validationbreast cancer survivorspatient-reported outcomesclinical oncology assessment

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Area of Science:

  • Oncology outcomes research within Functional Assessment of Cancer Therapy validation
  • Psychometric evaluation in clinical health psychology

Background:

Prior research has shown that advancements in oncology care have significantly raised survival rates for patients. This shift forces medical systems to address long-term patient well-being beyond initial disease management. Clinicians now prioritize monitoring health-related quality of life after a primary diagnosis. However, standardized tools for assessing these outcomes must be linguistically and culturally adapted for diverse populations. No prior work had resolved the need for a validated Italian instrument tailored to breast cancer survivors. That uncertainty drove the current effort to adapt existing international standards for local clinical use. The lack of such validated metrics hinders consistent monitoring of patient experiences across different healthcare settings. This gap motivated the formal assessment of a specific questionnaire designed to capture these complex patient-reported outcomes.

Purpose Of The Study:

The aim of this study was to validate the Italian version of the FACT-B+4 questionnaire and evaluate its reliability. Researchers sought to address the lack of culturally adapted tools for Italian breast cancer survivors. The project focused on ensuring that the translated instrument accurately captures patient-reported quality of life. By testing the tool in a surgical unit, the team intended to confirm its utility in clinical practice. This effort was motivated by the need to standardize outcome monitoring for patients post-diagnosis. The study specifically examined whether the Italian translation maintained the psychometric properties of the original English version. Establishing this reliability is necessary for effective long-term management of patient well-being. The authors designed the investigation to provide a robust, evidence-based resource for healthcare providers working within the Italian medical system.

Main Methods:

Review Approach involved a systematic validation of the translated questionnaire within a clinical setting. Investigators recruited 55 female subjects from a specialized surgical department for the assessment. The team administered the instrument on two separate occasions to evaluate stability. A three-day gap separated these sessions to ensure consistent reporting conditions. Statistical analysis focused on calculating Cronbach's alpha to determine internal consistency across the subscales. The researchers compared the performance of the Italian version against existing international data. This design allowed for a direct evaluation of the tool's reliability in a real-world patient population. The methodology prioritized rigorous psychometric testing to ensure the translated items accurately reflected the original intent.

Main Results:

Key Findings From the Literature indicate that the Italian version demonstrates strong internal consistency across its subscales. Most scores achieved Cronbach's alpha values greater than 0.7 during both the initial and follow-up assessments. These results confirm that the translated items function reliably for the target population. The data show that the instrument performs consistently with established English and Spanish versions. Participants in the surgical unit provided stable responses across the testing interval. The analysis supports the validity of the questionnaire for clinical use in Italy. No significant discrepancies appeared between the baseline and follow-up measurements. The findings establish the translated tool as an effective resource for measuring patient-reported outcomes in this demographic.

Conclusions:

Synthesis and Implications suggest the Italian instrument provides a dependable measure for clinical practice. Authors propose that the tool maintains high internal consistency across repeated assessments. The findings indicate that the translated version performs similarly to established English and Spanish counterparts. Researchers highlight that the questionnaire effectively captures quality of life metrics in this specific surgical cohort. The data support the use of this version for monitoring patient-reported outcomes in Italian breast units. Evidence confirms that the psychometric properties meet acceptable standards for clinical application. This work aligns with international efforts to standardize quality of life assessments globally. The study concludes that the translated questionnaire serves as a robust resource for healthcare providers managing breast cancer survivors.

The researchers propose that the Italian version achieves high internal consistency, with most subscale scores exceeding a Cronbach's alpha of 0.7. This threshold indicates that the items reliably measure the intended quality of life constructs, mirroring the performance observed in English and Spanish iterations.

The study utilized the Functional Assessment of Cancer Therapy - Breast (FACT-B+4) questionnaire. This specific instrument incorporates four additional items tailored to the unique concerns of breast cancer patients, distinguishing it from the broader version used for general oncology populations.

The authors state that administering the questionnaire twice with a three-day interval was necessary to assess test-retest reliability. This short duration minimizes the likelihood of actual changes in a patient's health status, ensuring that observed variations reflect the tool's stability rather than clinical progression.

The researchers employed Cronbach's alpha to quantify internal consistency. This statistical approach evaluates how closely related a set of items are as a group, confirming that the translated questions function cohesively to measure the underlying quality of life dimensions in the Italian cohort.

The study measured the consistency of responses across two time points, baseline and follow-up. By comparing these values, the authors demonstrated that the instrument maintains stable performance, providing evidence that the Italian version is a dependable metric for longitudinal patient monitoring.

The authors imply that this validated tool facilitates better management of post-diagnosis quality of life. By adopting this instrument, clinicians can align their monitoring practices with international standards, ultimately improving the systematic evaluation of patient-reported outcomes within Italian surgical units.