Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID07234461

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

Led by European Institute of Oncology · Updated on 2026-02-04

200

Participants Needed

19

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are collecting data from women who have undergone mastectomy and immediate breast reconstruction to understand their sexual well-being through surveys. This study aims to support better preoperative counseling and improve care for the side effects of cancer treatments. It also seeks to identify women with severe sexual impairment who might benefit from lifestyle changes and specialized interventions to enhance their quality of life. Participants are asked to complete questionnaires at a 1-year follow-up after their mastectomy and reconstruction surgery. These questionnaires gather sociodemographic information and details about their sexual well-being. The study includes women with various types of mastectomies and reconstruction procedures, including both unilateral and bilateral cases. During the study, participants will attend a medical consultation followed by completing the questionnaires about their sexual health. Researchers will measure sexual well-being as the primary outcome at enrollment. This study is observational in nature with no masking or placebo involved, and participation involves providing survey responses to help improve future care for breast cancer patients.

CONDITIONS

Brief Title

Sexual Well-being of Women Undergoing Mastectomy and Reconstruction

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing mastectomy for primary breast cancer
  • High-risk healthy patients undergoing risk reducing mastectomies
  • Unilateral and/or bilateral mastectomies
  • If unilateral mastectomy, patients requiring or not contralateral mammaplasty of the healthy breast
  • All reconstructive procedures included (autologous and heterologous reconstructions)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
3
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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Survey

Duration - 1-day

Participants complete questionnaires about their sociodemographic information and sexual well-being after their medical consultation at 1-year follow-up post-mastectomy and reconstruction.

1 visit (in-person or remote) at 1-year follow-up

Trial Site Locations

Total: 19 locations

1

Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, Italy, Italy, 70124

Not Yet Recruiting

2

Istituto Tumori Giovanni Paolo II

Bari, Italy, Italy, 70124

Not Yet Recruiting

3

Policlinico Sant'Orsola-Malpighi

Bologna, Italy, Italy, 40138

Not Yet Recruiting

4

Ospedale Bufalini di Cesena

Cesena, Italy, Italy, 47521

Not Yet Recruiting

5

Presidio Ospedaliero GB Morgagni-Pierantoni

Forlì, Italy, Italy, 47121

Not Yet Recruiting

6

European Institute of Oncology

Milan, Italy, Italy, 20141

Actively Recruiting

7

Ospedale Mater Olbia

Olbia, Italy, Italy, 07026

Not Yet Recruiting

8

Azienda Ospedale Università di Padova

Padova, Italy, Italy, 35128

Not Yet Recruiting

9

Policlinico Paolo Giaccone

Palermo, Italy, Italy, 90127

Not Yet Recruiting

10

Policlinico San Matteo

Pavia, Italy, Italy, 27100

Not Yet Recruiting

11

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy, Italy, 56100

Not Yet Recruiting

12

Campus Biomedico

Roma, Italy, Italy, 00128

Not Yet Recruiting

13

Istituto Tumori Regina Elena

Roma, Italy, Italy, 00144

Not Yet Recruiting

14

Policlinico Gemelli

Roma, Italy, Italy, 00168

Not Yet Recruiting

15

A.O.U. Città della salute e della scienza di Torino

Torino, Italy, Italy, 10126

Not Yet Recruiting

16

Azienda Ospedaliera di Treviso

Treviso, Italy, Italy, 31100

Not Yet Recruiting

17

Ospedale di Cattinara

Trieste, Italy, Italy, 34149

Not Yet Recruiting

18

Ospedale Universitario di Udine

Udine, Italy, Italy, 33100

Not Yet Recruiting

19

Breast Unit Settelaghi

Varese, Italy, Italy, 21100

Not Yet Recruiting

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Research Team

F

Francesca De Lorenzi, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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