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

Recruiting

• Conditions: Breast Cancer Female; Sexual Dysfunction; Premenopausal Breast Cancer
• Interventions: Other: Questionnaire

• Registration Number: NCT06458764
• Lead Sponsor: Candiolo Cancer Institute - IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14
• Primary Completion: 2024-12-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Questionnaire	-
Patients	Questionnaire	-

Primary Outcome Measures

Name	Time	Method
Sexual Dysfunction (SD) incidence	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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IRCCS Candiolo Cancer Center; 🇮🇹 Torino, TO, Italy