Multimedia-assisted Informed Consent Procedure for Patients Undergoing Mastectomy and Implant-bas… (NCT06541223) | Clinical Trial Compass
CompletedNot Applicable
Multimedia-assisted Informed Consent Procedure for Patients Undergoing Mastectomy and Implant-based Reconstruction
Italy265 participantsStarted 2024-01-02
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of current state of anxiety
Timeframe: 2 weeks
2
Evaluation of anxiety proneness
Timeframe: 2 weeks
3
Evaluation of uncertainty and perceptions of effective decision-making
Timeframe: 2 weeks
4
Evaluation of patients' understanding of plastic reconstruction procedures and surgical complications