Sexual Well-being of Women Undergoing Mastectomy and Reconstruction

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.

Recruiting

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Key information

Conditions

Mastectomy and Breast Reconstruction Sexual Wellness

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria Consorziale Policlinico, Bari, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Survey using a questionnaire.

Other

Questionnaires collecting sociodemographic information and their sexual well-being.

Primary outcomes

Sexual well-being

Time frame: Enrollment visit

Sexual well-being, a multidimensional construct, will be assessed using a combination of validated and non-validated questionnaires. For each outcome score, descriptive statistics will be reported, including mean, standard deviation, median, and interquartile range. Comparisons of mean scores across predefined subgroups-such as type of reconstruction, systemic and local treatments, menopausal status, obesity, and parity-will be conducted using analysis of variance. A p-value < 0.05 will be considered statistically significant.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca De Lorenzi, MD

CONTACT

[email protected]

+39 0257489.394

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

Sexual Well-being of Women Undergoing Mastectomy and Reconstruction: a National Survey.

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Nov 18, 2025
Registry last updated: Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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