Comparing Education Materials for Breast Reconstruction
This study is looking at the best way to give information to patients considering breast reconstruction after a mastectomy (surgery to remove a breast). It compares different types of educational materials: a five-module video series, a 20-page illustrated brochure, or a combination of both, against receiving no extra educational materials. The goal is to see if these materials can help reduce anxiety, improve how prepared you feel to make decisions, and increase your knowledge about reconstruction. You might be able to join if you are an adult aged 18 or older, are a new patient at the UCSF plastic surgery breast reconstruction clinic, and are considering a mastectomy. The study will measure your anxiety, decision-making preparation, and knowledge one day before your appointment with the surgeon.
- Study design
- This is an interventional study that plans to enroll 100 participants. You would be randomly assigned to one of four groups: written materials, video materials, combined materials, or no extra education.
- What's involved
- You will complete health-related questionnaires and review assigned educational materials. Data may also be collected from your medical record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Outcome measures are assessed at a single timepoint following your review of assigned materials and prior to your clinical consultation.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Merisa Piper, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Mean scores on the Spielberger State-Trait Anxiety Inventory (STAI), State Form1 day, during appointment immediately prior to meeting with surgeon
STAI is a 20 items instrument for assessing trait anxiety and 20 for state anxiety for a total of 40 items. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "1=Almost Never" to 4="Almost Always") with a maximum score range of 40-160 when all 40 items are administered. Higher scores indicate greater anxiety. Participants will complete STAI at baseline and during clinic visit with surgeon. Means, standard deviation, and group differences of the scores with confidence intervals will be reported.
- Mean scores on the Preparation for Decision Making (PrepDM) Scale -1 day, during appointment immediately prior to meeting with surgeon
The PrepDM is a validated 10-item tool that assesses a patient's perception of how well a decision aid or intervention, such as a decision aid, educational material, or clinical consultation, helps a patient feel prepared to make a health decision and discuss it with their practitioner. It evaluates a patient's perceived readiness across several aspects of decision-making, including understanding available options, recognizing benefits and risks, clarifying personal values, and feeling confident about communicating with healthcare providers. It uses a 5-point Likert scale (1=Not at all, 5=A great deal), with higher score reflecting greater perceived preparation for decision-making. Participants will complete PrepDM at baseline and during clinic visit with surgeon. Means, standard deviation, and group differences of the scores with confidence intervals will be reported.
- Mean scores on Reconstruction-Specific Knowledge Quiz1 day, during appointment immediately prior to meeting with surgeon
Reconstruction-specific knowledge quiz is a 7-item quiz. It is an author-developed instrument assessing knowledge of the reconstructive options covered in the educational materials, including implant-based reconstruction, autologous reconstruction, Goldilocks reconstruction, and the option of going flat. Participants will complete Reconstruction-Specific Knowledge Quiz at baseline and during clinic visit with surgeon. Means, standard deviation, and group differences of the scores with confidence intervals will be reported.