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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Questionnaires

    Other intervention

    Participants will complete health related questionnaires.

  • Video Health Education Materials

    Other intervention

    Five-module video series

  • Written Health Education Materials

    Other intervention

    20-page illustrated brochure

  • Medical Chart Review

    Other intervention

    Participants may have data collected from the medical record.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Written Educational InterventionExperimental treatment 3 interventions
Group B: Video Educational InterventionExperimental treatment 3 interventions
Group C: Combined Educational InterventionExperimental treatment 4 interventions
Group D: No Supplemental Education / Control ArmOther 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
1 day, during appointment immediately prior to meeting with surgeon
2

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.

Time frame
1 day, during appointment immediately prior to meeting with surgeon
3

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.

Time frame
1 day, during appointment immediately prior to meeting with surgeon

Secondary outcomes

Other outcomes

Sponsors and contacts

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