Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340386
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-26
Brief Title:
Italian Validation of a Tool for Assessing Sexual Function After Breast Cancer FSFI-BC
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
Italian Validation for the Female Sexual Function Index for Breast Cancer Patients FSFI-BC
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 N20 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
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 N20 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None