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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.

项目总结