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Идёт набор NCT07426913

Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab

Без фазы С лечением Breast Cancer Anthracycline Related Cardiotoxicity in Breast Cancer Virtual Reality Trastuzumab

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: Cardiovascular Health Education and Gaming through Virtual Reality.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Anthracycline Related Cardiotoxicity in Breast Cancer, Virtual Reality, Trastuzumab. Базовые параметры: от 18 лет · Женщины.
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 →
Официальное название

Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab - Phase 2

Обзор

The main goal of this study is to test a virtual reality (VR) program, Survivors' Virtual Reality Survivorship Experience (SurviVRSE), designed to help Breast Cancer survivors (n=30) learn about heart health. The aims are to test the usability, feasibility, and acceptability o the intervention. Additionally, follow-up assessments will examine changes in women's cancer therapy related cardiac dysfunction knowledge and heart healthy behaviors (e.g., physical activity).

Подробное описание

The long-term goal is to develop multilevel interventions and inform practice guidelines that mitigate the cancer therapy related cardiac dysfunction (CTRCD) burden in breast cancer survivors. The overall objective of this of this application is to develop and test a virtual reality (VR) intervention to educate breast survivors about their risk of developing CTRCD following treatment and about behavioral approaches to potentially mitigate risk. VR is emerging as an effective method for improving health-related knowledge, specifically in the context of CTRCD and cardiovascular risk factors, by allowing users to actively engage in medical content. Moreover, content can be tailored to groups of people and to each individual user. The central hypothesis is that the VR intervention will increase women's knowledge of the potential cardiovascular side effects of their treatment and of behavior modifications that may protect their hearts. This hypothesis was formulated preliminary data showing that survivors who received potentially cardiotoxic treatment recommended more information about their treatment and the importance of physical activity early in their primary treatment journey. The rationale for the proposed study is that although VR is gaining popularity as an educational tool, there remains a significant knowledge gap in its utilization in the context of cancer survivorship and implantation in clinic settings.

Вмешательства

  • Поведенческое Cardiovascular Health Education and Gaming through Virtual Reality
    Prior to engaging the intervention, participants will complete a baseline survey. The virtual reality intervention will be delivered at one infusion treatment. Participants will complete all education modules and affiliated games. The education focuses on potentially cardiotoxic treatments (e.g., anthracyclines), ways to identify cancer treatment related cardiovascular dysfunction, and heart healthy behaviors that survivors can initiate during survivorship. Following the intervention participant

Первичные конечные точки

  • CTRCD Knowledge [Срок оценки: Baseline, within 2 days post-Intervention, and 4 weeks post-intervention]
  • Usability [Срок оценки: Within 2 days post-Intervention]
  • Acceptability [Срок оценки: Within 2 days post-Intervention]
  • User Satisfaction [Срок оценки: Within 2 days post-Intervention]
Вторичные конечные точки (4)
  • Physical Activity [Срок оценки: Baseline and 4 weeks post-intervention]
  • Sleep Quality [Срок оценки: Baseline and 4 weeks post-intervention]
  • Tobacco Use [Срок оценки: Baseline and 4 weeks post-intervention]
  • Intent to Change Behavior [Срок оценки: Baseline, within 2 days post-Intervention, and 4 weeks post-intervention]

Критерии участия

Критерии включения

  • 18 years of age or older
  • Able to speak and read in English
  • Actively receiving Trastuzumab or an anthracycline-based treatment
  • Currently receiving immunotherapy. This includes pembrolizumab and atezolizumab.
  • Diagnosed with stages 0-III Breast Cancer

Критерии исключения

\- History of prior Breast Cancer diagnosis (i.e., not their first breast cancer diagnosis)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 3 центра
  • Adult Outpatient Pavilion — Richmond
  • Cellular Immunotherapies and Transplant Department — Richmond
  • VCU Health at Stony Point — Richmond

Идентификаторы

NCT: NCT07426913 · MCC-25-22806 · HM300000618

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗