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

NCT06340386 | Recruiting

• 1 other identifier: IEO 1365
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Validation of the italian translation of Female Sexual Function Index-Breast Cancer questionnaire

  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.

  12 months

Study Arms (2)

Patients with breast cancer and age <=50 years

Patients with diagnosis of breast cancer and age \<=50 years

Patients with breast cancer and age >50 years

Patients with diagnosis of breast cancer and age \>50 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated at European Institute of Oncology for a operable breast cancer between 2012 and 2020

You may qualify if:

• Women with operable breast cancer;
• Operated on between 2012 and 2020;
• Randomly selected from the institutional database; 18 years of age (Age stratification: equally represented women aged \<50 years and women aged ≥50 years);
• Signing of the informed consent.

You may not qualify if:

• Severe psychiatric or cognitive illness;
• Ongoing psychological treatment.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gabriella Pravettoni

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriella Pravettoni

CONTACT

+390257489731; gabriella.pravettoni@ieo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 1, 2024
• Study Start: October 19, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 1, 2024

Record last verified: 2024-03

Locations

IT (1)