Sexual Well-being of Women Undergoing Mastectomy and Reconstruction
2 other identifiers
interventional
200
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Shorter than P25 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2025
CompletedFirst Posted
Study publicly available on registry
November 18, 2025
CompletedStudy Start
First participant enrolled
January 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
February 4, 2026
January 1, 2026
8 months
November 14, 2025
February 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Survey
EXPERIMENTALAt 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.
Interventions
Questionnaires collecting sociodemographic information and their sexual well-being.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, Italy, 70124, Italy
Istituto Tumori Giovanni Paolo II
Bari, Italy, 70124, Italy
Policlinico Sant'Orsola-Malpighi
Bologna, Italy, 40138, Italy
Ospedale Bufalini di Cesena
Cesena, Italy, 47521, Italy
Presidio Ospedaliero GB Morgagni-Pierantoni
Forlì, Italy, 47121, Italy
European Institute of Oncology
Milan, Italy, 20141, Italy
Ospedale Mater Olbia
Olbia, Italy, 07026, Italy
Azienda Ospedale Università di Padova
Padua, Italy, 35128, Italy
Policlinico Paolo Giaccone
Palermo, Italy, 90127, Italy
Policlinico San Matteo
Pavia, Italy, 27100, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56100, Italy
Campus Biomedico
Roma, Italy, 00128, Italy
Istituto Tumori Regina Elena
Roma, Italy, 00144, Italy
Policlinico Gemelli
Roma, Italy, 00168, Italy
A.O.U. Città della salute e della scienza di Torino
Torino, Italy, 10126, Italy
Azienda Ospedaliera di Treviso
Treviso, Italy, 31100, Italy
Ospedale di Cattinara
Trieste, Italy, 34149, Italy
Ospedale Universitario di Udine
Udine, Italy, 33100, Italy
Breast Unit Settelaghi
Varese, Italy, 21100, Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2025
First Posted
November 18, 2025
Study Start
January 21, 2026
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
February 4, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share