Sexual Well-being of Women Undergoing Mastectomy and Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-21

Study Completion Date

2026-10-31

Brief Summary

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The study plans to collect data from patients on sexual well-being after mastectomy and immediate reconstruction by surveys.

This data can support preoperative patient counselling and the prevention and care of adverse effects of cancer treatments.

Specific subpopulations of mastectomy women showing severe sexual impairment can be outlined; they may benefit from lifestyle changes and intervention strategies (intravaginal use of diazepam, local hyaluronic acid, intravaginal use of spermidine, pelvic floor gymnastic and physiotherapy).

Our goal is to improve quality of life of breast cancer patients.

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Detailed Description

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Conditions

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Mastectomy and Breast Reconstruction Sexual Wellness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Survey

At 1-year follow-up, breast cancer patients who underwent mastectomy and reconstruction are asked to complete several questionnaires after the medical consultation collecting sociodemographic information and their sexual well-being.

Group Type EXPERIMENTAL

Survey using a questionnaire.

Intervention Type OTHER

Questionnaires collecting sociodemographic information and their sexual well-being.

Interventions

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Survey using a questionnaire.

Questionnaires collecting sociodemographic information and their sexual well-being.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing mastectomy for primary breast cancer;
* High-risk healthy patients undergoing risk reducing mastectomies;
* Unilateral and/or bilateral mastectomies;
* If unilateral mastectomy, both patients requiring or not contralateral mammaplasty of the healthy breast;
* All reconstructive procedures included (autologous and heterologous reconstructions).

Exclusion Criteria

* Patients undergoing breast conservation;
* Patients who previously underwent breast cancer treatment, requiring further surgery for local relapse or secondary breast cancers;
* Delayed post-mastectomy reconstructions;
* Patients not available for e-correspondence.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes