Clinical trial · Observational
Italian Validation of a Tool for Assessing Sexual Function After Breast Cancer, FSFI-BC
Italian Validation for the Female Sexual Function Index for Breast Cancer Patients (FSFI-BC)
NCT06340386CI-TRIAL-00075573unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a validation study of the italian language for the Female Sexual Function Index-Breast Cancer questionnaire. The validation of the instrument in Italian will allow the identification of possible issues related to sexual health and enable the provision of adequate medical and psychosexual counseling to these patients, both in clinical practice and in research studies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Patients with breast cancer and age <=50 years
- description
- Patients with diagnosis of breast cancer and age \<=50 years
- label
- Patients with breast cancer and age >50 years
- description
- Patients with diagnosis of breast cancer and age \>50 years
Primary outcomes (1)
- measure
- Validation of the italian translation of Female Sexual Function Index-Breast Cancer questionnaire
- timeFrame
- 12 months
- description
- The measure of internal consistency utilized is Cronbach's alpha (α). The comparison will be done between the estimated α in the Italian questionnaire and the α of the original work.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women with operable breast cancer; 2. Operated on between 2012 and 2020; 3. Randomly selected from the institutional database; 18 years of age (Age stratification: equally represented women aged \<50 years and women aged ≥50 years); 4. Signing of the informed consent. Exclusion Criteria: 1. Severe psychiatric or cognitive illness; 2. Ongoing psychological treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.