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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要老年人遭受与癌症治疗相关的毒性和进行性严重影响的风险较高。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），但常常管理不善，因为他们不相信自己的行为会自我管理 CINV 会有效许多老年人报告仅服用抗恶心药物。当 CINV 严重时，一些人会采取“观察等待”策略，等待 CINV 消失这种自我管理的缺乏会导致日常功能的减少和对工作的遵守程度的降低。治疗、增加医疗保健使用（急诊室和住院）和费用，以及生活质量较低，迫切需要新的策略来帮助老年人参与其中。在家中采取更积极的预防和自我管理行为，以减少负面结果。团队开发并测试了一种严肃的游戏干预措施，可以直接解决老年人的错误问题关于 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之前学到的有关 CINV 的知识针对化疗后在家中出现恶心高风险的化身的管理策略。我们的初步研究表明，玩家会做出预防 CINV 的决定并进行自我管理。研究表明，接受 eSSET-CINV 干预的老年人使用的剂量是其两倍 CINV 预防策略优于那些没有得到干预的人。确定 eSSET-CINV 在降低 CINV 严重程度和医疗保健使用方面的有效性，以及我们将使用 2 组（干预、注意力控制）来提高功能和生活质量。本研究的随机临床试验设计的目的 1 是检查 CINV 严重程度、自我评估的变化。管理行为、功能、生活质量、认知表征和医疗保健使用目标 2 是确定干预组从基线到研究完成的有效性。 eSSET-CINV 干预通过比较主要结果的差异（CINV 严重程度、医疗保健使用）和次要结果（自我管理行为、功能和生活质量）每次随访和完成研究时都会招募 500 名老年人作为样本。干预组将在基线时接收 eSSET-CINV，注意力控制组将在基线时接收 eSSET-CINV。研究结束后，我们将对两组进行为期 6 个月的跟踪研究。与文化相关的严肃游戏，让老年人练习制作与副作用相关的自我在无风险模拟环境中在家做出护理决策这项研究涉及 NIH 的研究。通过增加癌症症状预防和自我管理的优先事项在未充分研究的人群中采取积极的健康行为并改善健康结果。