Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab - Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- CTRCD Knowledge
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- History of prior Breast Cancer diagnosis (i.e., not their first breast cancer diagnosis)
研究组 & 干预措施
Virtual Reality Group
Individuals in this arm will receive access to the virtual reality in cardiovascular health education and gaming intervention
干预措施: Cardiovascular Health Education and Gaming through Virtual Reality (Behavioral)
结局指标
主要结局
CTRCD Knowledge
时间窗: Baseline, within 2 days post-Intervention, and 4 weeks post-intervention
Change in knowledge of CTRCD and in measures of improving cardiovascular health. This investigator-developed true/false knowledge survey consists of 10 items that directly assess knowledge learned in SurviVRSE. Scoring this scale will consist of summing up the total items that were answered correctly (range = 0-10; 0 = no knowledge and 10=high knowledge).
Usability
时间窗: Within 2 days post-Intervention
Usability will be assessed using the Virtual Reality System Usability Questionnaire. This 10-item measure includes prompts such as "I think I would like to use this system frequently" and "I thought the system was easy to use." Women will respond to the items using a 5-point Likert scale (1= strongly disagree and 5= strongly agree). Scores will be totaled (with some items requiring reverse-coding).
Acceptability
时间窗: Within 2 days post-Intervention
Acceptability will be assessed using the User Experience Questionnaire, a validated 8-item 7-point Likert scale survey that measures pragmatic and hedonic qualities of SurviVRSE (e.g., obstructive/supportive, complicated/easy). The UEC developers provide an Excel spreadsheet to analyze data collected from the tool. https://www.ueq-online.org/. The range of the scales is between -3 (horribly bad) to +3 (extremely good).
User Satisfaction
时间窗: Within 2 days post-Intervention
SurviVRSE satisfaction and engagement will be assessed using an adapted 6-item 5-point Likert scale survey (1=strongly disagree and 5=strongly agree). Items include "I could engage SurviVRSE," I would recommend SurviVRSE to another survivor," and "I liked the music." To evaluate satisfaction, the six items will be totaled. Scores will range from 6-30 with higher scores indicating greater satisfaction.
次要结局
- Physical Activity(Baseline and 4 weeks post-intervention)
- Sleep Quality(Baseline and 4 weeks post-intervention)
- Tobacco Use(Baseline and 4 weeks post-intervention)
- Intent to Change Behavior(Baseline, within 2 days post-Intervention, and 4 weeks post-intervention)