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Идёт набор NCT07324577

Effectiveness of Virtual Reality (VR) in the Management of Anxiety for Patients Undergoing Radiotherapy

Без фазы С лечением Radiation Therapy Virtual Reality

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: standard of care, Virtual Reality Intervention, Radiation Therapist Survey.
Кому может быть актуально
Состояния в реестре: Radiation Therapy, Virtual Reality. 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

Effectiveness of Virtual Reality in the Management of Anxiety for Patients Undergoing Radiotherapy

Обзор

The purpose of this study is to evaluate the use and functionality of virtual reality (VR) during radiation therapy treatments for patients with prostate, breast, lung, or head and neck cancer.

Подробное описание

This is a randomized controlled trial that will assess the feasibility, acceptability, tolerability, and initial clinical efficacy of using a VR device during radiation therapy for participants with prostate cancer, breast cancer, lung cancer, or head and neck cancer.

Participants will be randomized 2:1 to either the VR device intervention arm or the standard of care control arm.

Participants will undergo pre-study assessments, assessments before and after the first radiation treatment, every 6th radiation treatment, and at the end of treatment.

Вмешательства

  • Другое standard of care
    Radiation therapy for prostate cancer, breast cancer, lung cancer, or head and neck cancer.
  • Другое Virtual Reality Intervention
    Participants will wear the VR headset (Meta Quest 2) during standard of care radiation therapy
  • Другое Radiation Therapist Survey
    Radiation therapists will be asked about their experiences and proficiency with using the VR device.

Первичные конечные точки

  • VR Use During Treatment [Срок оценки: Periprocedural (each treatment visit)]
  • VR Functionality [Срок оценки: Periprocedural (each treatment visit)]
Вторичные конечные точки (2)
  • Anxiety - Change over time [Срок оценки: GAD-7: Baseline RTEQ: Periprocedural (After first and last treatment)]
  • Acceptability of Implementing VR [Срок оценки: At 36 months]

Критерии участия

Patients:

Критерии включения

  • Participants planned for radiation therapy for 15 or more treatments with non-neutron generating energies (10 MV or less) per study PI for prostate, breast, lung, or head and neck cancer. Neutrons have the potential to damage the VR headset device and are generated for energies above 10 MV.
  • Age 18 years or older at the time of consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-33 or Karnofsky (KPS) 30-100 at the time of enrollment.
  • Ability to understand and the willingness to sign an IRB-approved informed consent document directly.

Критерии исключения

  • Previous radiation therapy
  • VR device is determined to impede the radiation dosage during the VR device simulation and treatment planning
  • Participants with primary brain tumors, brain metastases, and cancer involving the sinuses, orbits, nose, or ears, are excluded from this clinical trial because the VR device may obstruct the area being treated
  • Participants with uncontrolled inter-current illness including but not limited to psychiatric illness/social situations that would limit compliance with study requirements per treating radiation oncologist.
  • Participants with known epilepsy, significant motion sickness, severe uncorrected visual impairment, severe uncorrected hearing impairment, or seizures, per participant report.
  • Participants with skin defects, infections, or open wounds in the area where the VR device is applied (face or scalp) or in the eyes per treating radiation oncologist.
  • Participants with pacemakers, internal defibrillators, hearing aid, or other implanted medical device. The Meta Quest device contains magnets and components that emit magnetic/electromagnetic fields which could affect the operation of nearby electronics and medical devices.

Radiation Therapists:

Критерии включения

  • Agreement to participate after reviewing the information sheet
  • Radiation therapist at AHWFBCCC High Point who has treated at least one participant who enrolled on to the study and used the VR device.

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
  • Atrium Health Wake Forest Baptist Hayworth Cancer Center — High Point

Идентификаторы

NCT: NCT07324577 · IRB00140668 · P30CA012197 · ONC-LUN-2407

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗