NCT06541223Completed
Multimedia-assisted Informed Consent Procedure for Patients Undergoing Mastectomy and Implant-based Reconstruction
Effect of a Multimedia-assisted Informed Consent Procedure on the Information Gain, Satisfaction and Anxiety of Patients Undergoing Mastectomy and Implant-based Reconstruction
Source: ClinicalTrials.gov · Last updated 7 Aug 2024
Brief summary (registry, in English)
Breast reconstruction is a women's right with positive psychological effects and it is an integral part of breast cancer treatment and care. A preoperative counselling is mandatory, providing information about oncologic surgery, the type of reconstruction and the expected results. This study plans to compare conventional informed consent process supported by informational brochures with a multimedia video-assisted procedure supported by the same informational brochures in breast cancer patients undergoing immediate implant-based reconstruction. The two processes will be compared in terms of information retention, patient satisfaction of the informed consent process and anxiety levels before surgery.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 265 (actual)
- First submitted
- 2 Aug 2024
- Start date
- 2 Jan 2024
- Primary completion date
- 25 Jun 2024
- Lead sponsor
- European Institute of Oncology
- Diseases
- Childhood cancers
- NCT number
- NCT06541223
What you commit to
- Study type: Observational
- Participants enrolled: 265
- From 2 Jan 2024 to the primary completion date, 25 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who previously underwent unilateral mastectomy and implant reconstruction, requiring contralateral mastectomy
Other
- Patients undergoing mastectomy and autologous reconstruction
- Patients not available for e-correspondence
Who the study is looking for
- Patients undergoing mastectomy for 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
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| European Institute of Oncology Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.