Menu
Recruiting NCT07602374

Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction

No phase Interventional Breast Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires, Video Health Education Materials, Written Health Education Materials, Medical Chart Review.
Who it may be relevant to
Registry conditions: Breast Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Detailed description

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

Interventions

  • Other Questionnaires
    Participants will complete health related questionnaires.
  • Other Video Health Education Materials
    Five-module video series
  • Other Written Health Education Materials
    20-page illustrated brochure
  • Other Medical Chart Review
    Participants may have data collected from the medical record.

Primary outcome measures

  • Mean scores on the Spielberger State-Trait Anxiety Inventory (STAI), State Form [Time frame: 1 day, during appointment immediately prior to meeting with surgeon]
  • Mean scores on the Preparation for Decision Making (PrepDM) Scale - [Time frame: 1 day, during appointment immediately prior to meeting with surgeon]
  • Mean scores on Reconstruction-Specific Knowledge Quiz [Time frame: 1 day, during appointment immediately prior to meeting with surgeon]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT07602374 · 26754 · NCI-2026-03675

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗