Sexual Well-being of Women Undergoing Mastectomy and Reconstruction

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mastectomy and Breast Reconstruction; Sexual Wellness
• Intervention / Treatment: Other: Survey using a questionnaire.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesca De Lorenzi, MD; Phone Number: +39 0257489.394; Email: francesca.delorenzi@ieo.it

Study Locations

• Italy
  • Italy
    • Bari, Italy, Italy, 70124
      • Not yet recruiting
      • Azienda Ospedaliero Universitaria Consorziale Policlinico
      • Contact: Angela Gurrado, MD; Phone Number: +39 080 919 8749; Email: urp.policlinico.bari@pec.rupar.puglia.it
      • Principal Investigator: Angela Gurrado, MD
    • Bari, Italy, Italy, 70124
      • Not yet recruiting
      • Istituto Tumori Giovanni Paolo II
      • Contact: Daniela Anna Cutrignelli, MD; Phone Number: +39 0805555917; Email: d.cutrignelli@oncologico.bari.it
      • Principal Investigator: Daniela Anna Cutrignelli, MD
    • Bologna, Italy, Italy, 40138
      • Not yet recruiting
      • Policlinico Sant'Orsola-Malpighi
      • Contact: Chiara Gelati, MD; Phone Number: +39 051 2143614; Email: angela.sandoni@aosp.bo.it
      • Principal Investigator: Chiara Gelati, MD
    • Cesena, Italy, Italy, 47521
      • Not yet recruiting
      • Ospedale Bufalini di Cesena
      • Contact: Rossella Sgarzani, MD; Phone Number: +39 0547 352111; Email: rossella.sgarzani2@unibo.it
      • Principal Investigator: Rossella Sgarzani, MD
    • Forlì, Italy, Italy, 47121
      • Not yet recruiting
      • Presidio Ospedaliero GB Morgagni-Pierantoni
      • Contact: Annalisa Curcio, MD; Phone Number: +39 0543731676; Email: curcioannalisa@hotmail.it
      • Principal Investigator: Annalisa Curcio, MD
    • Milan, Italy, Italy, 20141
      • Recruiting
      • European Institute of Oncology
      • Contact: Francesca De Lorenzi, MD; Phone Number: +39 0257489.394; Email: francesca.delorenzi@ieo.it
      • Principal Investigator: Francesca De Lorenzi, MD
    • Olbia, Italy, Italy, 07026
      • Not yet recruiting
      • Ospedale Mater Olbia
      • Contact: Sonia Bove, MD; Phone Number: +39 0789 18999; Email: sonia.bove@materolbia.com
      • Principal Investigator: Sonia Bove, MD
    • Padua, Italy, Italy, 35128
      • Not yet recruiting
      • Azienda Ospedale Università di Padova
      • Contact: Laura Pandis, MD; Phone Number: +39 0498212768; Email: chir.plastica@aopd.veneto.it
      • Principal Investigator: Laura Pandis, MD
    • Palermo, Italy, Italy, 90127
      • Not yet recruiting
      • Policlinico Paolo Giaccone
      • Contact: Adriana Cordova, MD; Phone Number: +39 091 655 34 00; Email: adriana.cordova@policlinico.pa.it
      • Principal Investigator: Adriana Cordova, MD
    • Pavia, Italy, Italy, 27100
      • Not yet recruiting
      • Policlinico San Matteo
      • Contact: Adele Sgarella, MD; Phone Number: +39 0382502288; Email: a.sgarella@smatteo.pv.it
      • Principal Investigator: Adele Sgarella, MD
    • Pisa, Italy, Italy, 56100
      • Not yet recruiting
      • Azienda Ospedaliero Universitaria Pisana
      • Contact: Manuela Roncella, MD; Phone Number: +39 050992729; Email: s.palmiero@ao-pisa.toscana.it
      • Principal Investigator: Manuela Roncella, MD
    • Roma, Italy, Italy, 00128
      • Not yet recruiting
      • Campus Biomedico
      • Contact: Barbara Cagli, MD; Phone Number: +39 06 9762 0968; Email: b.cagli@unicampus.it
      • Principal Investigator: Barbara Cagli, MD
    • Roma, Italy, Italy, 00144
      • Not yet recruiting
      • Istituto Tumori Regina Elena
      • Contact: Lucia Mangialardi, MD; Phone Number: +39 351 319 1190; Email: segreteria.drmangialardi@gmail.com
      • Principal Investigator: Lucia Mangialardi, MD
    • Roma, Italy, Italy, 00168
      • Not yet recruiting
      • Policlinico Gemelli
      • Contact: Marzia Salgarello, MD; Phone Number: +39 06 3015.4667; Email: marzia.salgarello@policlinicogemelli.it
      • Principal Investigator: Marzia Salgarello, MD
    • Torino, Italy, Italy, 10126
      • Not yet recruiting
      • A.O.U. Città della Salute e Della Scienza di Torino
      • Contact: Maria Alessandra Bocchiotti, MD; Phone Number: +39 0116336991; Email: mariaalessandra.bocchiotti@unito.it
      • Principal Investigator: Maria Alessandra Bocchiotti, MD
    • Treviso, Italy, Italy, 31100
      • Not yet recruiting
      • Azienda Ospedaliera di Treviso
      • Contact: Elisa Antoniazzi, MD; Phone Number: +39 0422 322372; Email: segchgen3tv@aulss2.veneto.it
      • Principal Investigator: Elisa Antoniazzi, MD
    • Trieste, Italy, Italy, 34149
      • Not yet recruiting
      • Ospedale di Cattinara
      • Contact: Nadia Renzi, MD; Phone Number: +39 040 3994258; Email: nadia.renzi@asugi.sanita.fvg.it
      • Principal Investigator: Nadia Renzi, MD
    • Udine, Italy, Italy, 33100
      • Not yet recruiting
      • Ospedale Universitario di Udine
      • Contact: Glenda Caputo, MD; Phone Number: +39 0432 559432; Email: urp@policlinicoudine.it
      • Principal Investigator: Glenda Caputo, MD
    • Varese, Italy, Italy, 21100
      • Not yet recruiting
      • Breast Unit Settelaghi
      • Contact: Francesca Rovera, MD; Phone Number: +39 0332 278111; Email: francesca.rovera@uninsubria.it
      • Principal Investigator: Francesca Rovera, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Survey; 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.	Other: Survey using a questionnaire.; Questionnaires collecting sociodemographic information and their sexual well-being.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual well-being	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.	Enrollment visit

Collaborators and Investigators

• Sponsor: European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: UID 4897; L2-367 (Other Identifier: Comitato Etico Territoriale Lombardia 2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No