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

NCT ID: NCT06541223

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 265 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2024-06-25

Brief 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.

Detailed Description

Implant-based reconstruction is the most frequent procedure after mastectomy, able to preserve body integrity and femininity. Breast reconstruction is a women's right with positive psychological effects. It is an integral part of breast cancer treatment and care, and in the vast majority of cases it is performed in the immediate setting. Breast reconstruction is personalized and tailored to each patient, taking in consideration patient anatomy and comorbidities, cancer staging and oncologic rules and even patient desires. Patient expectations are very high and women are seeking for outstanding cosmetic results especially in case of prophylactic surgery, therefore preoperative counselling is mandatory, providing information about oncologic surgery, the type of reconstruction and the expected results. A detailed informed consent procedure must include explanations of the surgical procedure, including its benefits, alternatives and risks, information about the implants (temporary or definitive ones) and postoperative scenarios. The face-to-face discussion is supported by information brochures that include all this information. Unfortunately, the readability of these documents is often not high and the rate of information retention might be low. Recently, it has been observed that the amount of information retained by patients appears to improve using a multi-media video-assisted informed consent procedure. Aim of this study is to evaluate if a multimedia-assisted video tutorial before implant-based reconstruction could increase the information retained by patients, their satisfaction about the informed consent process and influence their anxiety levels before surgery.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Standard Informed Consent Procedure

Face-to-face informed consent procedure supported by an informational brochure approved by the hospital committee

Standard informed consent procedure

Intervention Type: OTHER

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

Multimedia Assisted Informed Consent Procedure

Face-to-face informed consent procedure supported by an informational brochure approved by the hospital committee, followed by a multimedia presentation on implant-based reconstruction

Standard informed consent procedure

Intervention Type: OTHER

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

Multimedia video

Intervention Type: OTHER

Multimedia presentation on implant-based reconstruction

Interventions

Standard informed consent procedure

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

Intervention Type: OTHER

Multimedia video

Multimedia presentation on implant-based reconstruction

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Patients undergoing mastectomy and autologous reconstruction
• Patients who previously underwent unilateral mastectomy and implant reconstruction, requiring contralateral mastectomy
• Patients not available for e-correspondence

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesca De Lorenzi, MD

Role: PRINCIPAL_INVESTIGATOR

European Istitute of Oncology

Locations

European Institute of Oncology

Milan, , Italy

Countries

Italy

Other Identifiers

IEO 1999

Identifier Type: -

Identifier Source: org_study_id