Sexual well-being after mastectomy and immediate reconstruction

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

We will collect short electronic questionnaires from women having mastectomy with immediate reconstruction to see how the surgery affects sexual well‑being.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: European Institute of Oncology (Academic / other)
• Locations: 19 sites (Bari, Italy and 18 other locations)
• Trial ID: NCT07234461 on ClinicalTrials.gov

What this trial studies

This observational project will collect standardized questionnaire data on sexual well‑being from women undergoing mastectomy with immediate reconstruction at three Italian cancer centers. Eligible participants include women having unilateral or bilateral mastectomy for primary breast cancer or for risk reduction, with any type of immediate reconstruction; delayed reconstructions and breast‑conserving surgery are excluded. Questionnaires will be administered electronically and used to identify patient subgroups with severe sexual impairment and links to surgical or patient factors. Results are intended to inform preoperative counseling and help prioritize candidates for lifestyle changes, pelvic floor therapy, or local interventions.

Who should consider this trial

Good fit: Women undergoing unilateral or bilateral mastectomy with immediate reconstruction for primary or risk‑reducing indications who can receive and return electronic questionnaires are ideal candidates.

Not a fit: Patients who have breast‑conserving surgery, delayed post‑mastectomy reconstruction, prior breast cancer treatments requiring further surgery, or who cannot be reached by e‑correspondence are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could help clinicians provide better preoperative counseling and target treatments to improve sexual health and quality of life after mastectomy.

How similar studies have performed: Previous observational studies have documented sexual impairment after mastectomy, and small trials of pelvic floor therapy and local topical treatments have shown mixed but sometimes promising results.

Eligibility criteria

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.

Where this trial is running

Bari, Italy and 18 other locations

• Azienda Ospedaliero Universitaria Consorziale Policlinico — Bari, Italy, Italy (Not_yet_recruiting)
• Istituto Tumori Giovanni Paolo II — Bari, Italy, Italy (Not_yet_recruiting)
• Policlinico Sant'Orsola-Malpighi — Bologna, Italy, Italy (Not_yet_recruiting)
• Ospedale Bufalini di Cesena — Cesena, Italy, Italy (Not_yet_recruiting)
• Presidio Ospedaliero GB Morgagni-Pierantoni — Forlì, Italy, Italy (Not_yet_recruiting)
• European Institute of Oncology — Milan, Italy, Italy (Recruiting)
• Ospedale Mater Olbia — Olbia, Italy, Italy (Not_yet_recruiting)
• Azienda Ospedale Università di Padova — Padova, Italy, Italy (Not_yet_recruiting)
• Policlinico Paolo Giaccone — Palermo, Italy, Italy (Not_yet_recruiting)
• Policlinico San Matteo — Pavia, Italy, Italy (Not_yet_recruiting)
• Azienda Ospedaliero Universitaria Pisana — Pisa, Italy, Italy (Not_yet_recruiting)
• Campus Biomedico — Roma, Italy, Italy (Not_yet_recruiting)
• Istituto Tumori Regina Elena — Roma, Italy, Italy (Not_yet_recruiting)
• Policlinico Gemelli — Roma, Italy, Italy (Not_yet_recruiting)
• A.O.U. Città della salute e della scienza di Torino — Torino, Italy, Italy (Not_yet_recruiting)
• Azienda Ospedaliera di Treviso — Treviso, Italy, Italy (Not_yet_recruiting)
• Ospedale di Cattinara — Trieste, Italy, Italy (Not_yet_recruiting)
• Ospedale Universitario di Udine — Udine, Italy, Italy (Not_yet_recruiting)
• Breast Unit Settelaghi — Varese, Italy, Italy (Not_yet_recruiting)

Study contacts

• Study coordinator: Francesca De Lorenzi, MD

Conditions Mastectomy and Breast Reconstruction; Sexual Wellness