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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
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06340386
Enrollment
600
Registered
2024-04-01
Start date
2020-10-19
Completion date
2024-12-31
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief 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.

Interventions

None listed

Sponsors

European Institute of Oncology
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Validation of the italian translation of Female Sexual Function Index-Breast Cancer questionnaire12 monthsThe 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.

Countries

Italy

Contacts

Primary ContactGabriella Pravettoni
gabriella.pravettoni@ieo.it+390257489731

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026