Sexual Well-being of Women Undergoing Mastectomy and Reconstruction

NCT07234461 — Not applicable, Recruiting, 200 participants, European Institute of Oncology

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

RegistryNCT07234461
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, other
Enrollment200 (Estimated)
SponsorEuropean Institute of Oncology (Other)
ConditionsMastectomy and Breast Reconstruction, Sexual Wellness
InterventionsSurvey using a questionnaire. (Other)
Datesstart 2026-01-21, primary completion 2026-10-01 (estimated), completion 2026-10-01 (estimated), first posted 2025-11-18, last updated 2026-02-04
Locations19 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.

-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
SurveyExperimentalOther: 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.
  • Survey using a questionnaire. (Other): Questionnaires collecting sociodemographic information and their sexual well-being.

+Outcome measures

Primary outcomes

  • Sexual well-being [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.

+Eligibility

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.

+Locations (19)

FacilityCityCountryStatus
Azienda Ospedaliero Universitaria Consorziale PoliclinicoBari, ItalyItalyNot yet recruiting
Istituto Tumori Giovanni Paolo IIBari, ItalyItalyNot yet recruiting
Policlinico Sant'Orsola-MalpighiBologna, ItalyItalyNot yet recruiting
Ospedale Bufalini di CesenaCesena, ItalyItalyNot yet recruiting
Presidio Ospedaliero GB Morgagni-PierantoniForlì, ItalyItalyNot yet recruiting
European Institute of OncologyMilan, ItalyItalyRecruiting
Ospedale Mater OlbiaOlbia, ItalyItalyNot yet recruiting
Azienda Ospedale Università di PadovaPadova, ItalyItalyNot yet recruiting
Policlinico Paolo GiacconePalermo, ItalyItalyNot yet recruiting
Policlinico San MatteoPavia, ItalyItalyNot yet recruiting
Azienda Ospedaliero Universitaria PisanaPisa, ItalyItalyNot yet recruiting
Campus BiomedicoRoma, ItalyItalyNot yet recruiting
Istituto Tumori Regina ElenaRoma, ItalyItalyNot yet recruiting
Policlinico GemelliRoma, ItalyItalyNot yet recruiting
A.O.U. Città della salute e della scienza di TorinoTorino, ItalyItalyNot yet recruiting
Azienda Ospedaliera di TrevisoTreviso, ItalyItalyNot yet recruiting
Ospedale di CattinaraTrieste, ItalyItalyNot yet recruiting
Ospedale Universitario di UdineUdine, ItalyItalyNot yet recruiting
Breast Unit SettelaghiVarese, ItalyItalyNot yet recruiting