Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruc… (NCT07602374) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction
United States100 participantsStarted 2026-06-06
Plain-language summary
This is a prospective, randomized controlled trial evaluating the comparative efficacy of written, video, and combined written and video patient education materials relative to no supplemental education for University of California, San Francisco (UCSF) patients presenting for post-mastectomy breast reconstruction consultation.
Who can participate
Age range
18 Years
Sex
ALL
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:
* Adults aged 18 or older
* Presenting as a new patient to the UCSF plastic surgery breast reconstruction clinic
* Considering mastectomy, including:
* \- Therapeutic mastectomy in the setting of a breast cancer diagnosis
* \- Prophylactic mastectomy in the setting of a confirmed high-risk genetic variant
* \- Staged procedures, including delayed mastectomy with initial reduction
* Participants who are undecided between lumpectomy and mastectomy
Exclusion Criteria:
* Established patients returning for follow-up, in order to minimize confounding variables of individual surgeon education style on outcome measures
* Participants who are primarily considering lumpectomy or oncoplastic reduction at the time of their visit
* Non-English speakers, as educational materials are currently available in English only
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
Mean scores on the Spielberger State-Trait Anxiety Inventory (STAI), State Form
Timeframe: 1 day, during appointment immediately prior to meeting with surgeon
2
Mean scores on the Preparation for Decision Making (PrepDM) Scale -
Timeframe: 1 day, during appointment immediately prior to meeting with surgeon
3
Mean scores on Reconstruction-Specific Knowledge Quiz
Timeframe: 1 day, during appointment immediately prior to meeting with surgeon