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| ID | Type | Description | Link |
|---|---|---|---|
| L2-367 | Other Identifier | Comitato Etico Territoriale Lombardia 2 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Survey | Experimental | At 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey using a questionnaire. | Other | Questionnaires collecting sociodemographic information and their sexual well-being. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesca De Lorenzi, MD | Contact | +39 0257489.394 | francesca.delorenzi@ieo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Consorziale Policlinico | Not yet recruiting | Bari | Italy | 70124 | Italy |
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| Istituto Tumori Giovanni Paolo II | Not yet recruiting | Bari | Italy | 70124 | Italy |
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| Policlinico Sant'Orsola-Malpighi | Not yet recruiting | Bologna | Italy | 40138 | Italy |
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| Ospedale Bufalini di Cesena | Not yet recruiting | Cesena | Italy | 47521 | Italy |
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| Presidio Ospedaliero GB Morgagni-Pierantoni | Not yet recruiting | Forlì | Italy | 47121 | Italy |
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| European Institute of Oncology | Recruiting | Milan | Italy | 20141 | Italy |
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| Ospedale Mater Olbia | Not yet recruiting | Olbia | Italy | 07026 | Italy |
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| Azienda Ospedale Università di Padova | Not yet recruiting | Padova | Italy | 35128 | Italy |
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| Policlinico Paolo Giaccone | Not yet recruiting | Palermo | Italy | 90127 | Italy |
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| Policlinico San Matteo | Not yet recruiting | Pavia | Italy | 27100 | Italy |
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| Azienda Ospedaliero Universitaria Pisana | Not yet recruiting | Pisa | Italy | 56100 | Italy |
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| Campus Biomedico | Not yet recruiting | Roma | Italy | 00128 | Italy |
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| Istituto Tumori Regina Elena | Not yet recruiting | Roma | Italy | 00144 | Italy |
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| Policlinico Gemelli | Not yet recruiting | Roma | Italy | 00168 | Italy |
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| A.O.U. Città della salute e della scienza di Torino | Not yet recruiting | Torino | Italy | 10126 | Italy |
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| Azienda Ospedaliera di Treviso | Not yet recruiting | Treviso | Italy | 31100 | Italy |
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| Ospedale di Cattinara | Not yet recruiting | Trieste | Italy | 34149 | Italy |
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| Ospedale Universitario di Udine | Not yet recruiting | Udine | Italy | 33100 | Italy |
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| Breast Unit Settelaghi | Not yet recruiting | Varese | Italy | 21100 | Italy |
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