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

10. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • California
      • San Francisco, California, Forente stater, 94143
        • Rekruttering
        • University of California, San Francisco
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Questionnaires
Participants will complete health related questionnaires.
Andre navn:
  • Undersøkelser
Annen: Written Health Education Materials
20-page illustrated brochure
Andre navn:
  • Health Education Materials
Annen: Medical Chart Review
Participants may have data collected from the medical record.
Andre navn:
  • Kartgjennomgang
Eksperimentell: 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.
Annen: Questionnaires
Participants will complete health related questionnaires.
Andre navn:
  • Undersøkelser
Annen: Medical Chart Review
Participants may have data collected from the medical record.
Andre navn:
  • Kartgjennomgang
Annen: Video Health Education Materials
Five-module video series
Andre navn:
  • Health Education Materials
Eksperimentell: 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.
Annen: Questionnaires
Participants will complete health related questionnaires.
Andre navn:
  • Undersøkelser
Annen: Written Health Education Materials
20-page illustrated brochure
Andre navn:
  • Health Education Materials
Annen: Medical Chart Review
Participants may have data collected from the medical record.
Andre navn:
  • Kartgjennomgang
Annen: Video Health Education Materials
Five-module video series
Andre navn:
  • Health Education Materials
Annen: 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.
Annen: Questionnaires
Participants will complete health related questionnaires.
Andre navn:
  • Undersøkelser
Annen: Medical Chart Review
Participants may have data collected from the medical record.
Andre navn:
  • Kartgjennomgang

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean scores on the Spielberger State-Trait Anxiety Inventory (STAI), State Form
Tidsramme: 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 -
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California, San Francisco

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. juni 2026

Primær fullføring (Antatt)

31. mars 2028

Studiet fullført (Antatt)

31. mars 2029

Datoer for studieregistrering

Først innsendt

11. mai 2026

Først innsendt som oppfylte QC-kriteriene

18. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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