Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541223
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Multimedia-assisted Informed Consent Procedure for Patients Undergoing Mastectomy and Implant-based Reconstruction
Sponsor:
None
Organization:
None
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast reconstruction is a womens 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 womens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None