Sexual Well-being of Women Undergoing Mastectomy and Reconstruction

European Institute of Oncology

Status: Enrolling

Conditions: Sexual Wellness; Mastectomy and Breast Reconstruction

Treatments: Other: Survey using a questionnaire.

Study type: Interventional

Funder types: Other

Identifiers

NCT07234461

L2-367 (Other Identifier)

UID 4897

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Survey

Experimental group

Description:

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.

Treatment:

Other: Survey using a questionnaire.