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

Candiolo Cancer Institute - IRCCS1 site in 1 country150 target enrollmentMay 1, 2023

ConditionsBreast Cancer Female Sexual Dysfunction Premenopausal Breast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer Female
Sponsor: Candiolo Cancer Institute - IRCCS
Enrollment: 150
Locations: 1
Primary Endpoint: Sexual Dysfunction (SD) incidence
Status: Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2023

End Date

December 1, 2025

Last Updated

10 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Candiolo Cancer Institute - IRCCS

Responsible Party

Principal Investigator

Giada Pozzi

Candiolo Cancer Institute - IRCCS

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.