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Идёт набор NCT07602374

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

Без фазы С лечением Breast Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Questionnaires, Video Health Education Materials, Written Health Education Materials, Medical Chart Review.
Кому может быть актуально
Состояния в реестре: Breast Surgery. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

  • Другое Questionnaires
    Participants will complete health related questionnaires.
  • Другое Video Health Education Materials
    Five-module video series
  • Другое Written Health Education Materials
    20-page illustrated brochure
  • Другое Medical Chart Review
    Participants may have data collected from the medical record.

Первичные конечные точки

  • Mean scores on the Spielberger State-Trait Anxiety Inventory (STAI), State Form [Срок оценки: 1 day, during appointment immediately prior to meeting with surgeon]
  • Mean scores on the Preparation for Decision Making (PrepDM) Scale - [Срок оценки: 1 day, during appointment immediately prior to meeting with surgeon]
  • Mean scores on Reconstruction-Specific Knowledge Quiz [Срок оценки: 1 day, during appointment immediately prior to meeting with surgeon]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT07602374 · 26754 · NCI-2026-03675

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗