Italian Validation of a Tool for Assessing Sexual Function After Breast Cancer, FSFI-BC

Breast Cancer Clinical Trial

Official title:

Italian Validation for the Female Sexual Function Index for Breast Cancer Patients (FSFI-BC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06340386
• Other study ID #: IEO 1365
• Status: Recruiting
• Start date: October 19, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Gabriella Pravettoni
• Phone: +390257489731
• Email: gabriella.pravettoni[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of the italian translation of Female Sexual Function Index-Breast Cancer questionnaire	The measure of internal consistency utilized is Cronbach's alpha (a). The comparison will be done between the estimated a in the Italian questionnaire and the a of the original work.	12 months