Overview
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.
Description
PRIMARY OBJECTIVES:
- Assess baseline knowledge, procedural confidence, and anxiety in patients presenting for breast reconstruction consultation.
- Compare post-intervention outcomes between patients receiving written, video, or combined educational materials relative to no supplemental education.
SECONDARY OBJECTIVES
1\. Examine whether the relative efficacy of each modality differs across patient subgroups defined by age, area deprivation index score, and prior health literacy.
- OUTLINE
Participants will be randomized into 1 of 4 groups:
- Written educational intervention
- Video educational intervention
- Combined written and video educational intervention
- No additional educational intervention
Outcome measures are assessed at a single timepoint following participant review of assigned materials and prior to the clinical consultation. Enrolled participants who do not review their assigned educational materials prior to the clinical consultation will be excluded from primary analysis but will be included in secondary intent-to-treat analysis
Eligibility
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
