Serious gaming for chemotherapy-induced nausea and vomiting in older adults with cancer: A randomized clinical trial

项目摘要 老年人与癌症治疗相关的毒性和进行性严重反应的风险更高。 他们经历了癌症治疗的许多副作用，包括化疗引起的副作用 恶心和呕吐(CINV)，但往往控制不住，因为他们不相信自己的行为 自我管理的CINV将是有效的。许多老年人报告说只服用抗恶心药物 当CINV很严重，有些人在等待CINV离开时采取了一种‘警惕等待’的策略 它自己的。这种自我管理的缺乏导致日常功能的减少，减少对 治疗、增加的医疗保健使用(急诊科和住院人数)和成本，以及 生活质量较低。迫切需要新的战略来帮助老年人参与 在家庭中采取更积极的预防性和自我管理行为，以减少负面后果。我们的 团队开发并测试了一种严肃的游戏干预措施，直接针对老年人的错误 关于CINV管理的信念。ESSET-CINV干预是一种基于技术的教育 在模拟中，老年人学习应用他们以前学到的关于CINV自我的知识 化身化疗后在家中出现恶心的高危人群的管理策略。 玩家做出决定，以防止CINV并在它发生时自我管理。我们的初步研究 结果显示，接受eSSET-CINV干预的老年人使用的药物是对照组的两倍 CINV的预防策略比那些没有得到干预的人要好。这项研究的目标是 确定eSSET-CINV在降低CINV严重性和医疗保健使用方面的有效性 提高功能和生活质量。我们将使用2组(干预、注意力控制) 随机临床试验设计。本研究的目的1是检查CINV严重程度的变化，自评 管理行为、功能、生活质量、认知表征和医疗保健使用 干预组从基线到研究完成。目标2是确定该药的疗效 ESSET-通过比较主要结果(CINV严重性、医疗保健)的差异进行CINV干预 使用)和次要结果(自我管理行为、功能和生活质量) 每一次跟踪访问并完成研究。将招募500名老年人作为样本。这个 干预组在基线时接受eSSET-CINV，注意控制组在 研究结束。两组均随访6个月。我们的长期目标是开发出独特的、 与文化相关的严肃游戏，允许老年人练习制作与副作用相关的自我 在无风险的模拟环境中在家进行护理决策。这项研究致力于美国国立卫生研究院的研究 促进改变癌症症状预防和自我管理的优先事项 在研究不足的人群中积极的健康行为和改善的健康结果。

Project Summary Older adults are at higher risk of toxicity and progressive severe effects related to cancer treatment. They experience numerous side effects from cancer treatment including chemotherapy-induced nausea and vomiting (CINV), but often undermanage it because they do not believe their actions to self-manage CINV will be effective. Many older adults report taking anti-nausea medication only when CINV is severe and some adopt a ‘watchful waiting” strategy as they wait for CINV to go away on its own. This lack of self- management leads to reduced daily functioning, reduced adherence to treatment, increased healthcare use (emergency department and hospital admissions) and cost, and lower quality of life. There is a critical need for new strategies to assist older adults in engaging in more active preventative and self-management behaviors at home to reduce negative outcomes. Our team developed and tested a serious game intervention that directly addresses older adults’ erroneous beliefs about CINV management. The eSSET-CINV intervention is a technology-based educational simulation in which older adults learn to apply what they have previously learned about CINV self- management strategies to an avatar who is at high risk for nausea at home after chemotherapy. Players make decisions to prevent CINV and to self-manage it when it occurs. Our preliminary study showed that older adults who were exposed to the eSSET-CINV intervention used twice as many CINV preventative strategies than those who did not get the intervention. The goal of this study is to determine the eSSET-CINV’s effectiveness at reducing CINV severity and healthcare use and increasing functioning and quality of life. We will use a 2-group (intervention, attention control) randomized clinical trial design. Aim 1 of this study is to examine changes in CINV severity, self- management behaviors, functioning, QOL, cognitive representation and healthcare use within the intervention group from baseline to completion of the study. Aim 2 is to determine efficacy of the eSSET-CINV intervention by comparing differences in primary outcomes (CINV severity, healthcare use) and secondary outcomes (self-management behaviors, functioning, and QOL) between groups at each follow-up visit and completion of the study. A sample of 500 older adults will be recruited. The intervention group will receive the eSSET-CINV at baseline, the attention control will receive it at the end of the study. Both groups will be followed for 6 months. Our long-term goal is to develop unique, culturally relevant serious games that allow older adults to practice making side-effect related self- care decisions at home in a no-risk simulated environment. This research addresses the NIH research priorities facilitating changes in cancer symptom prevention and self-management through increasing positive health behaviors and improved health outcomes in an understudied population.