About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 or older
Presenting as a new patient to the UCSF plastic surgery breast reconstruction clinic
- Therapeutic mastectomy in the setting of a breast cancer diagnosis
- Prophylactic mastectomy in the setting of a confirmed high-risk genetic variant
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Questionnaires
Other interventionParticipants will complete health related questionnaires.
Video Health Education Materials
Other interventionFive-module video series
Written Health Education Materials
Other intervention20-page illustrated brochure
Medical Chart Review
Other interventionParticipants may have data collected from the medical record.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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