Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Merisa Piper, MD (ucsf)

Description

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.

Official Title

Evaluating the Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction Patients: Knowledge, Confidence, and Anxiety

Details

PRIMARY OBJECTIVES:

  1. Assess baseline knowledge, procedural confidence, and anxiety in patients presenting for breast reconstruction consultation.
  2. 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:

  1. Written educational intervention
  2. Video educational intervention
  3. Combined written and video educational intervention
  4. 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

Keywords

Breast Surgery, Health Education, Surveys and Questionnaires, Video Health Education Materials, Written Health Education Materials, Medical Chart Review

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at University of California Health

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07602374
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated