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

认真玩游戏可治疗老年癌症患者化疗引起的恶心和呕吐：一项随机临床试验

• 批准号: 10710034
• 负责人: Victoria Loerzel
• 金额: $ 50万
• 依托单位: UNIVERSITY OF CENTRAL FLORIDA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-26 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10710034
• 关键词: Accident and Emergency department; Address; Adherence; Adopted; Adult; Age; Age Years; Antiemetics; Behavior; Belief; Cancer Patient; Clinical Trials Design; Cognitive; Control Groups; Data; Decision Making; Dehydration; Education; Effectiveness; Elderly; Electronics; Emergency department visit; Enrollment; Environment; Exclusion; Exposure to; Florida; Food; Fright; Goals; Guidelines; Health; Health behavior; Healthcare; Home; Hospitalization; Impairment; Intervention; Kidney; Learning; Liquid substance; Malignant Neoplasms; Nausea; Nausea and Vomiting; Nausea and Vomiting Therapy; Newly Diagnosed; Oncologist; Outcome; Pain; Participant; Patient observation; Patient-Focused Outcomes; Patients; Perception; Pharmaceutical Preparations; Physicians; Pilot Projects; Play; Population; Prevention; Prevention strategy; Provider; Psychological reinforcement; Quality of life; Randomized; Reporting; Research; Research Personnel; Research Priority; Rest; Risk; Risk Reduction; Sample Size; Sampling; Self Care; Self Management; Severities; Symptoms; Technology; Testing; Toxic effect; Training; Treatment-related toxicity; United States National Institutes of Health; Visit; Visualization; Work; academic standard; adverse event risk; attentional control; cancer diagnosis; cancer therapy; care seeking; chemotherapy; clinical research site; cognitive change; comparison control; comparison intervention; cost; daily functioning; effectiveness evaluation; efficacy evaluation; experience; follow-up; functional improvement; group intervention; high risk; improved; non-compliance; novel; prevent; primary outcome; randomized, clinical trials; recruit; secondary outcome; side effect; simulation; symptom self management; young adult

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.

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。