Sexual well-being after mastectomy and immediate reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• European Institute of Oncology
  Milan, Italy, Italy Recruiting
• 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

Study contacts

• Study coordinator: Francesca De Lorenzi, MD
• Email: francesca.delorenzi@ieo.it
• Phone: +39 0257489.394

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.