跳至主要内容
临床试验/NCT04278534
NCT04278534终止不适用

A Randomized Controlled Trial to Assess the Effectiveness of Virtual Reality in Education for Cancer Patients Undergoing Radiation Therapy

OHSU Knight Cancer Institute4 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2020年5月28日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
27
试验地点
4
主要终点
Knowledge of radiation therapy (RT)

研究概览

简要总结

This trial studies the use of virtual reality as an educational tool for cancer patients undergoing radiation therapy. The purpose of the study is to learn about virtual reality education (VERT) and if it may be able to help people who are planning to receive radiation therapy. Patient education using virtual reality may result in better understanding and/or decreased anxiety in patients receiving radiation therapy.

详细描述

PRIMARY OBJECTIVE:

I. To assess if proximal knowledge regarding radiation therapy (RT) treatment is improved as result of radiation therapist-led education sessions utilizing VERT.

SECONDARY OBJECTIVE:

I. To assess if proximal anxiety related to first RT is reduced as result of radiation therapist-led education sessions utilizing VERT.

EXPLORATORY OBJECTIVES:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to understand and the willingness to sign a written informed consent document
  • All races and ethnic groups will be included
  • Participants with any cancer diagnosis that is intended to receive RT for curative intent for their cancer
  • Participants must have a minimum of 10 planned RT treatments

排除标准

  • Any prior RT
  • Known history of anxiety or depression
  • Individuals with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results
  • Inability to understand either English or Spanish

结局指标

主要结局

Knowledge of radiation therapy (RT)

时间窗: Prior to start of planned RT, on the first treatment day up to completion of the virtual reality education (VERT) intervention of planned RT (up to 9 weeks)

Measured by part 1 of the Radiation Therapy Patient Education Survey by start of RT. The sum of scores from Survey 1.1 for Arm 1 will be compared with that of Arm 2 (using total scores from Survey 1.0 for Arm 2 control group \[CG\]1 and total scores from Survey 1.1 for Arm 2 CG2) using two-sided two-sample t test. Linear regression models will be fitted for adjusted comparison after controlled for disease sites and other important patient and tumor characteristics.

次要结局

  • Anxiety in radiation therapy(Prior to start of planned RT, on the first treatment day up to completion of the VERT intervention of planned RT (up to 9 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristi Tonning

Principal Investigator

OHSU Knight Cancer Institute

研究点 (4)

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