Actively Recruiting
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
Eligibility Criteria
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)
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
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
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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