Mastectomy and Breast Reconstruction, Sexual Wellness
Conditions
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.
Interventions
OTHERSurvey using a questionnaire.
Questionnaires collecting sociodemographic information and their sexual well-being.
Sponsors
European Institute of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sexual well-being | Enrollment visit | 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. |
Countries
Italy
Contacts
CONTACTFrancesca De Lorenzi, MD
Outcome results
None listed