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Recruiting NCT07234461

Sexual Well-being of Women Undergoing Mastectomy and Reconstruction

No phase Interventional Mastectomy and Breast Reconstruction Sexual Wellness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Survey using a questionnaire..
Who it may be relevant to
Registry conditions: Mastectomy and Breast Reconstruction, Sexual Wellness. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Sexual Well-being of Women Undergoing Mastectomy and Reconstruction: a National Survey.

Overview

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

  • Other Survey using a questionnaire.
    Questionnaires collecting sociodemographic information and their sexual well-being.

Primary outcome measures

  • Sexual well-being [Time frame: Enrollment visit]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Italy · 19 centers
  • Azienda Ospedaliero Universitaria Consorziale Policlinico — Bari
  • Istituto Tumori Giovanni Paolo II — Bari
  • Policlinico Sant'Orsola-Malpighi — Bologna
  • Ospedale Bufalini di Cesena — Cesena
  • Presidio Ospedaliero GB Morgagni-Pierantoni — Forlì
  • European Institute of Oncology — Milan
  • Ospedale Mater Olbia — Olbia
  • Azienda Ospedale Università di Padova — Padova
  • … and 11 more centers

Identifiers

NCT: NCT07234461 · UID 4897 · L2-367

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗