Sexual Well-being of Women Undergoing Mastectomy and Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEuropean Institute of Oncology
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Survey using a questionnaire.
Other interventionQuestionnaires collecting sociodemographic information and their sexual well-being.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: SurveyExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Enrollment visitSponsors and contacts
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Source ClinicalTrials.gov