Clinical trial NCT06541223: Multimedia-assisted Informed Consent Procedure for Patients Undergoing Mastectomy and Implant-based Reconstruction
Official title: Effect of a Multimedia-assisted Informed Consent Procedure on the Information Gain, Satisfaction and Anxiety of Patients Undergoing Mastectomy and Implant-based Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
High-risk healthy patients
Implant-based reconstruction
Multimedia-assisted informed consent procedure
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 265
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing mastectomy and implant-based reconstruction (both with definitive implants and temporary prostheses or expanders)

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.

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

Primary outcomes:
measure: Evaluation of current state of anxiety
timeFrame: 2 weeks
measure: Evaluation of anxiety proneness
timeFrame: 2 weeks
measure: Evaluation of uncertainty and perceptions of effective decision-making
timeFrame: 2 weeks
measure: Evaluation of patients' understanding of plastic reconstruction procedures and surgical complications
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Istitute of Oncology
name: Francesca De Lorenzi, MD
role: PRINCIPAL_INVESTIGATOR
References: