Breast CancerNCT06340386
Italian Validation of a Tool for Assessing Sexual Function After Breast Cancer, FSFI-BC
An observational study of Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 19 Oct 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at European Institute of Oncology for a operable breast cancer between 2012 and 2020
Who may be able to join
- 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.
Who cannot join
- Severe psychiatric or cognitive illness;
- Ongoing psychological treatment.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan
Gabriella Pravettoni
About this study
Official title: Italian Validation for the Female Sexual Function Index for Breast Cancer Patients (FSFI-BC)
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.
Read the detailed description
The original version of the questionnaire will be validated in two phases: a) translation, b) reliability.
- 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:
- forward translation by two independent translators (from English to Italian);
- synthesis (discussion between translators to resolve any discrepancies);
- backward translation (from Italian to English) by two additional independent translators;
- 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.
- 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.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start19 Oct 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriella Pravettoni, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340386
- Sponsor's protocol ID
- IEO 1365
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Validation for the Female Sexual Function Index for Breast Cancer Patients (FSFI-BC)
- ClinicalTrials.gov ID
- NCT06340386
- Acronym / sponsor ID
- IEO 1365
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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:
- forward translation by two independent translators (from English to Italian);
- synthesis (discussion between translators to resolve any discrepancies);
- backward translation (from Italian to English) by two additional independent translators;
- 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.
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at European Institute of Oncology for a operable breast cancer between 2012 and 2020
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Severe psychiatric or cognitive illness;
- Ongoing psychological treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of the italian translation of Female Sexual Function Index-Breast Cancer questionnaire
Time frame: 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriella Pravettoni principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriella Pravettoni (+390257489731, gabriella.pravettoni@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the italian translation of Female Sexual Function Index-Breast Cancer questionnaire (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.