Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction
Evaluating the Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction Patients: Knowledge, Confidence, and Anxiety
2 other identifiers
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2026
CompletedFirst Posted
Study publicly available on registry
May 22, 2026
CompletedStudy Start
First participant enrolled
June 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
Study Completion
Last participant's last visit for all outcomes
March 31, 2029
May 22, 2026
May 1, 2026
1.8 years
May 11, 2026
May 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Mean scores on the Spielberger State-Trait Anxiety Inventory (STAI), State Form
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.
1 day, during appointment immediately prior to meeting with surgeon
Mean scores on the Preparation for Decision Making (PrepDM) Scale -
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.
1 day, during appointment immediately prior to meeting with surgeon
Mean scores on Reconstruction-Specific Knowledge Quiz
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.
1 day, during appointment immediately prior to meeting with surgeon
Study Arms (4)
Written Educational Intervention
EXPERIMENTALOn the day of consultation prior to meeting with the plastic surgeon, participants will receive a 20-page illustrated brochure covering the full range of reconstructive options and be asked to complete surveys. Following the appointment, a medical chart review will be conducted.
Video Educational Intervention
EXPERIMENTALOn the day of consultation prior to meeting with the plastic surgeon, participants will receive a five-module video series totaling approximately 20 minutes featuring the senior author and will be asked to complete surveys; expected to take no longer than 10 minutes to complete. Following the appointment, a medical chart review will be conducted.
Combined Educational Intervention
EXPERIMENTALOn the day of consultation prior to meeting with the plastic surgeon, participants in the combined arm will receive both written and video materials and will be asked to complete surveys. Following the appointment, a medical chart review will be conducted.
No Supplemental Education / Control Arm
OTHEROn the day of consultation prior to meeting with the plastic surgeon, participants will be asked to complete surveys. Following the appointment, a medical chart review will be conducted.
Interventions
Participants will complete health related questionnaires.
Five-module video series
20-page illustrated brochure
Participants may have data collected from the medical record.
Eligibility Criteria
You may qualify if:
- 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Merisa Piper, MD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2026
First Posted
May 22, 2026
Study Start (Estimated)
June 30, 2026
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2029
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share