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

10 juni 2026 bijgewerkt door: University of California, San Francisco

Evaluating the Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction Patients: Knowledge, Confidence, and Anxiety

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • California
      • San Francisco, California, Verenigde Staten, 94143
        • Werving
        • University of California, San Francisco
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Written Educational Intervention
On 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.
Ander: Questionnaires
Participants will complete health related questionnaires.
Andere namen:
  • Enquêtes
Ander: Written Health Education Materials
20-page illustrated brochure
Andere namen:
  • Health Education Materials
Ander: Medical Chart Review
Participants may have data collected from the medical record.
Andere namen:
  • Grafiek review
Experimenteel: Video Educational Intervention
On 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.
Ander: Questionnaires
Participants will complete health related questionnaires.
Andere namen:
  • Enquêtes
Ander: Medical Chart Review
Participants may have data collected from the medical record.
Andere namen:
  • Grafiek review
Ander: Video Health Education Materials
Five-module video series
Andere namen:
  • Health Education Materials
Experimenteel: Combined Educational Intervention
On 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.
Ander: Questionnaires
Participants will complete health related questionnaires.
Andere namen:
  • Enquêtes
Ander: Written Health Education Materials
20-page illustrated brochure
Andere namen:
  • Health Education Materials
Ander: Medical Chart Review
Participants may have data collected from the medical record.
Andere namen:
  • Grafiek review
Ander: Video Health Education Materials
Five-module video series
Andere namen:
  • Health Education Materials
Ander: No Supplemental Education / Control Arm
On 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.
Ander: Questionnaires
Participants will complete health related questionnaires.
Andere namen:
  • Enquêtes
Ander: Medical Chart Review
Participants may have data collected from the medical record.
Andere namen:
  • Grafiek review

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean scores on the Spielberger State-Trait Anxiety Inventory (STAI), State Form
Tijdsspanne: 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.
1 day, during appointment immediately prior to meeting with surgeon
Mean scores on the Preparation for Decision Making (PrepDM) Scale -
Tijdsspanne: 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.
1 day, during appointment immediately prior to meeting with surgeon
Mean scores on Reconstruction-Specific Knowledge Quiz
Tijdsspanne: 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.
1 day, during appointment immediately prior to meeting with surgeon

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, San Francisco

Onderzoekers

  • Hoofdonderzoeker: Merisa Piper, MD, University of California, San Francisco

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 juni 2026

Primaire voltooiing (Geschat)

31 maart 2028

Studie voltooiing (Geschat)

31 maart 2029

Studieregistratiedata

Eerst ingediend

11 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 mei 2026

Eerst geplaatst (Werkelijk)

22 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

10 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 26754
  • NCI-2026-03675 (Register-ID: NCI Clinical Trials Reporting Program (CTRP))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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