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Multimedia-assisted Informed Consent Procedure for Patients Undergoing Mastectomy and Implant-based Reconstruction

NCT06541223 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 265

Last updated 2024-08-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Standard informed consent procedure

Face-to-face informed consent procedure supported by informational brochure

OTHER

Multimedia video

Multimedia presentation on implant-based reconstruction

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Francesca De Lorenzi, MD · European Istitute of Oncology

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2024-06-25
Completion
2024-06-25

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06541223 on ClinicalTrials.gov