Sexual Well-being of Women Undergoing Mastectomy and Reconstruction: a National Survey.
| Registry | NCT07234461 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, other |
| Enrollment | 200 (Estimated) |
| Sponsor | European Institute of Oncology (Other) |
| Conditions | Mastectomy and Breast Reconstruction, Sexual Wellness |
| Interventions | Survey using a questionnaire. (Other) |
| Dates | start 2026-01-21, primary completion 2026-10-01 (estimated), completion 2026-10-01 (estimated), first posted 2025-11-18, last updated 2026-02-04 |
| Locations | 19 sites in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Mastectomy and Breast Reconstruction All trials for Sexual Wellness All trials of Survey using a questionnaire.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Survey | Experimental | Other: Survey using a questionnaire. | 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. |
Sex: Female, ages: 18 Years to any, 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.
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |