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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06340386
Other study ID # IEO 1365
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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