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

March 26, 2024 updated by: European Institute of Oncology

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.

Study Overview

Status

Recruiting

Conditions

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 (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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy
        • Recruiting
        • European Institute of Oncology
        • Contact:
          • Gabriella Pravettoni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Investigators

  • Principal Investigator: Gabriella Pravettoni, European Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO 1365

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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