Validation of a questionnaire for assessing sexual function in breast cancer patients in Italian
Italian Validation for the Female Sexual Function Index for Breast Cancer Patients (FSFI-BC)
European Institute of Oncology · NCT06340386
This study is testing a new Italian questionnaire to help women with breast cancer understand and talk about their sexual health issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | European Institute of Oncology (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT06340386 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the Female Sexual Function Index-Breast Cancer questionnaire in the Italian language. The validation process involves translating the original questionnaire, assessing its usability through a small sample of volunteers, and ensuring its reliability by re-administering it after two weeks. This will help identify sexual health issues in breast cancer patients and facilitate appropriate medical and psychosexual counseling. The study is observational and focuses on women with operable breast cancer who were treated between 2012 and 2020.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with operable breast cancer who were treated between 2012 and 2020.
Not a fit: Patients with severe psychiatric or cognitive illnesses or those undergoing ongoing psychological treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding and management of sexual health issues in Italian-speaking breast cancer patients.
How similar studies have performed: Other studies have successfully validated similar questionnaires in different languages, indicating that this approach is both tested and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan
- European Institute of Oncology — Milan, Italy (RECRUITING)
Study contacts
- Principal investigator: Gabriella Pravettoni — European Institute of Oncology
- Study coordinator: Gabriella Pravettoni
- Email: gabriella.pravettoni@ieo.it
- Phone: +390257489731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer