NCT06340386

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The original version of the questionnaire will be validated in two phases: a) translation, b) reliability. 1. Translation of the items and administration to a small sample of volunteers to assess usability. In the first phase, the questionnaire will be translated following the 5 steps: 1. forward translation by two independent translators (from English to Italian); 2. synthesis (discussion between translators to resolve any discrepancies); 3. backward translation (from Italian to English) by two additional independent translators; 4. expert committee (translators, psychologists, sexology consultants) comparing the two versions of the questionnaire; 5) testing the first version of the questionnaire with a sample (N=20) of native Italian speakers to evaluate the adequacy of content and clarity of terms used and proceeding to the final version. 2. Reliability of the questionnaire. To assess the reliability of the questionnaire, it will be administered again after a 2-week interval to a smaller sample compared to the recruited patient sample.

Conditions

• Breast Cancer

Timeline

• Start date: 2020-10-19
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-04-01
• Last updated: 2024-04-01

Locations

1 site across 1 country: Italy