Breast Surgery
Conditions
Keywords
Health Education
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.
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
OTHERQuestionnaires
Participants will complete health related questionnaires.
OTHERVideo Health Education Materials
Five-module video series
OTHERWritten Health Education Materials
20-page illustrated brochure
OTHERMedical Chart Review
Participants may have data collected from the medical record.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean scores on the Spielberger State-Trait Anxiety Inventory (STAI), State Form | 1 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 Quiz | 1 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. |
Countries
United States
Contacts
CONTACTReta Behman, BA
PRINCIPAL_INVESTIGATORMerisa Piper, MD
University of California, San Francisco
Outcome results
None listed