Sexual Dysfunction Check-up in Premenopausal Breast Cancer Survivors Taking Endocrine Therapy: A Cross-Sectional Study (SEXCHECK)

June 18, 2025 updated by: Giada Pozzi, Candiolo Cancer Institute - IRCCS

SEXCHECK - Sexual Dysfunction Check-up in Premenopausal Breast Cancer Survivors Taking Endocrine Therapy: A Cross-Sectional Study

Primary objectives:

  • To estimate Sexual Dysfunction (SD) incidence in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.
  • To detect the presence of SD-related distress in the population, as a determining factor in the maintenance of a good quality of life.

Secondary objectives:

  • To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens.
  • Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

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

Study Locations

  • Italy
    • TO
      • Torino, TO, Italy, 10060
        • Recruiting
        • IRCCS Candiolo Cancer Center
        • Contact:

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

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women aged ≥18 and ≤ 55 who underwent surgery for early stage breast cancer, taking endocrine therapy for at least 3 months

Description

Inclusion Criteria:

  • women aged ≥18 and ≤ 55
  • who underwent surgery for early stage breast cancer
  • taking endocrine therapy for at least 3 months
  • providing an informed consent and completing the study questionnaires.

Exclusion Criteria:

  • withdrawal of the informed consent, at any time

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
Intervention / Treatment
Controls
Other: Questionnaire
none, it's a incidence-prevalence study
Patients
Other: Questionnaire
none, it's a incidence-prevalence study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual Dysfunction (SD) incidence
Time Frame: 6 months
To estimate Sexual Dysfunction (SD) incidence (physiological parameter) in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.
6 months
SD-related distress
Time Frame: 6 months
To detect the presence of SD-related distress (physiological parameter) in the population, as a determining factor in the maintenance of a good quality of life.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SD characteristics
Time Frame: 6 months
To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens.
6 months
Collect baseline data
Time Frame: 6 months
Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population.
6 months

Collaborators and Investigators

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

Sponsor

Candiolo Cancer Institute - IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 18, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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