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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Informed Consent Procedure | Face-to-face informed consent procedure supported by an informational brochure approved by the hospital committee |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard informed consent procedure | Other | Face-to-face informed consent procedure supported by informational brochure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of current state of anxiety | Collection of Spielberger State/Trait Anxiety Inventory (STAI) Y1 questionnaire (minimum value: 1, maximum value: 4 - higher scores mean greater anxiety) | 2 weeks |
| Evaluation of anxiety proneness | Collection of Spielberger State/Trait Anxiety Inventory (STAI) Y2 questionnaire (minimum value: 1, maximum value: 4 - higher scores mean greater anxiety) | 2 weeks |
| Evaluation of uncertainty and perceptions of effective decision-making | Collection of Decisional Conflict Scale (DCS) questionnaire (minimum value: 1, maximum value: 5 - higher scores mean higher decisional conflict) | 2 weeks |
| Evaluation of patients' understanding of plastic reconstruction procedures and surgical complications | Collection of Reconstructive Breast Surgery Comprehension Questionnaire (minimum value: 1, maximum value: 4 - higher scores mean better understanding) | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing mastectomy and implant-based reconstruction (both with definitive implants and temporary prostheses or expanders)
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| Name | Affiliation | Role |
|---|---|---|
| Francesca De Lorenzi, MD | European Istitute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Milan | 20141 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Multimedia video | Other | Multimedia presentation on implant-based reconstruction |
|
| D017437 |
| Skin and Connective Tissue Diseases |