Trial Summary
What is the purpose of this trial?The purpose of this study is to examine the effectiveness of a technology-based intervention for managing nausea and vomiting in older adults with cancer. Participants will be randomized to either an intervention or control group. Outcomes such as symptom severity, quality of life, and resource use will be examined.
Is the treatment eSSET-CINV a promising treatment for nausea and vomiting?Yes, eSSET-CINV is a promising treatment because it uses a serious game to help older adults manage nausea and vomiting caused by chemotherapy. This approach is engaging and helps patients learn how to better handle their symptoms.23467
What safety data exists for the serious gaming treatment for nausea and vomiting?The provided research does not contain specific safety data for the serious gaming treatment for nausea and vomiting, including under the name eSSET-CINV. The studies focus on different serious games related to educational purposes and health interventions, but none directly address safety data for the treatment in question.5891011
What data supports the idea that Serious Gaming for Nausea and Vomiting (also known as: eSSET-CINV) is an effective treatment?The available research shows that Serious Gaming for Nausea and Vomiting is being explored as a way to help older adults manage chemotherapy-induced nausea and vomiting. One study highlights that older adults often struggle with managing side effects from cancer treatment, and serious games could be a new educational strategy to teach them how to handle these symptoms better. Although the research does not provide specific data on its effectiveness compared to other treatments, it suggests that serious games are being considered as a promising tool for symptom management.12347
Do I have to stop taking my current medications?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for people aged 60 or older who have recently been diagnosed with cancer and are starting chemotherapy that's known to cause moderate to severe nausea and vomiting. They must be on a treatment cycle of 2, 3, or 4 weeks, speak English fluently, and have access to a telephone.Inclusion Criteria
I am 60 years old or older.
I have recently been diagnosed with cancer.
I am currently on or have been treated with chemotherapy that often causes vomiting.
Treatment Details
The study is testing 'eSSET-CINV', a technology-based intervention aimed at managing chemotherapy-induced nausea and vomiting in older adults. Participants will be randomly placed into either the group receiving this intervention or a control group not receiving it.
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
This intervention is a serious game which allows older adults under treatment for cancer to practice making self-care decisions for an avatar that is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with the research assistant about choices related to managing nausea and vomiting at home
Group II: ControlActive Control1 Intervention
The control group will receive standard education related to managing nausea and vomiting and will have the opportunity to participate in the intervention at the end of the study
Find a clinic near you
Research locations nearbySelect from list below to view details:
Miller School of Medicine Sylvester Comp. Cancer CenterMiami, FL
Orlando HealthOrlando, FL
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Who is running the clinical trial?
University of Central FloridaLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
University of MiamiCollaborator
Orlando Health, Inc.Collaborator
References
What to expect from immersive virtual environment exposure: influences of gender, body mass index, and past experience. [2017]For those interested in using head-coupled PC-based immersive virtual environment (VE) technology to train, entertain, or inform, it is essential to understand the effects this technology has on its users. This study investigated potential adverse effects, including the sickness associated with exposure and extreme responses (emesis, flashbacks). Participants were exposed to a VE for 15 to 60 min, with either complete or streamlined navigational control and simple or complex scenes, after which time measures of sickness were obtained. More than 80% of participants experienced nausea, oculomotor disturbances, and/or disorientation, with disorientation potentially lasting > 24 hr. Of the participants, 12.9% prematurely ended their exposure because of adverse effects; of these, 9.2% experienced an emetic response, whereas only 1.2% of all participants experienced emesis. The results indicate that designers may be able to reduce these rates by limiting exposure duration and reducing the degrees of freedom of the user's navigational control. Results from gender, body mass, and past experience comparisons indicated it may be possible to identify those who will experience adverse effects attributable to exposure and warn such individuals. Applications for this research include military, entertainment, and any other interactive systems for which designers seek to avoid adverse effects associated with exposure.
Development and validation of the pediatric nausea assessment tool for use in children receiving antineoplastic agents. [2022]To develop and validate an instrument to assess nausea intensity in children aged 4-18 years.
Motion sickness, console video games, and head-mounted displays. [2017]We evaluated the nauseogenic properties of commercial console video games (i.e., games that are sold to the public) when presented through a head-mounted display.
Using a community advisory board to develop a serious game for older adults undergoing treatment for cancer. [2019]Older adults undergoing treatment for cancer are at risk for serious complications such as chemotherapy-induced nausea and vomiting (CINV). Older adults are often overwhelmed by information and under-manage cancer treatment-related side effects. New educational strategies such as serious gaming may help teach or reinforce key symptom self-management strategies. This paper describes how a community advisory board of older adults, their caregivers, and oncology nurses were consulted to develop a serious game for CINV.
Precision gaming for health: Computer games as digital medicine. [2019]Health based games have significant potential as therapeutic interventions due to the inherent mechanisms associated with social and individual game play and their capacity for sensor integration, data capture analysis and patient feedback. Moreover, they are low cost and they can be deployed at the point of care across an evolving digital ecosystem. However, a robust evidence base to support their wider adoption as a clinical intervention for chronic diseases is lacking and significant methodological barriers exist for health games developers creating efficacious 'digital medicines'. Game design is complex and it must utilise validated game mechanics balanced with a creative and engaging game design. The aim of this review is therefore to outline the fundamental steps of game development for health professionals and to critically appraise the methodology for assessing health games as medical interventions. This requires (1) The adoption of clearly defined global language for health games development based on a targeted function as therapeutic agents. (2) The development of multidisciplinary teams with a broad portfolio of development and clinical skill sets. (3) The creation of health game engines specifically built to facilitate clinical game development. (4) Robust trial design and assessment of translational impact: If games are to be prescribed, their efficacy and toxicity must be based on a rigorous assessment of their use within a real world clinical environment. Trials for precision health games have specific challenges around blinding, learning curves, bias and confounding that are particularly problematic. We propose the adoption of the IDEAL-GAMES framework for game development that systematically assess and validates games through open registries. In conclusion we propose a new framework for assessing the robustness and clinical efficacy of games for health as clinical interventions in the clinical environment.
The Impact of a Novel Gaming Reinforcement System on Oral Intake Outcomes in Pediatric Feeding Therapy: A Single Case Study. [2020]Purpose The aim of this study was to implement a novel reinforcement strategy into traditional dysphagia therapy with a school-age child diagnosed with a rare genetic syndrome, anxiety, and a hypersensitive gag reflex response. This clinical focus article evaluated the impact of a computer-based straw-drinking game on total liquid volume intake and the relationship between motivation and its role in feeding therapy. Method A longitudinal pilot study was used and required the development and implementation of a computer-based straw-drinking game as a novel reinforcement strategy. The gaming system was implemented to supplement ongoing dysphagia treatment in a single-subject case study design utilizing a client with pediatric dysphagia. Results The participant exhibited a trend of increased endurance during therapy sessions, allowing for increased volume per sip, increased trials per session, and decreased time between sequential trials. Average daily volume of oral intake remained less than 30 ml. Conclusions The gaming system maximized opportunities for orosensory desensitization of tactile input, resulting in increased comfort and endurance during therapy sessions, leading to more opportunities to practice the swallow. A novelty effect was observed as motivation and interest in the gaming system appeared greatest at the onset of the study. Generalized fatigue and anxiety continue to serve as barriers to more significant progress.
Using Serious Games to Increase Prevention and Self-Management of Chemotherapy-Induced Nausea and Vomiting in Older Adults With Cancer. [2021]To examine the frequency and types of preventive and self-management behaviors reported by participants, as well as report acceptability and usability data for the electronic Symptom Self-Management Training-Chemotherapy-Induced Nausea and Vomiting (CINV) serious game.
Schisto and Ladders version 2: a health educational board game to support compliance with school-based mass drug administration with praziquantel - a pilot study. [2021]We redesigned the Schisto and Ladders health educational board game and evaluated its potential to encourage compliance to school-based mass drug administration with praziquantel.
Development and evaluation of a serious game to support learning among pharmacy and nursing students. [2021]Serious games (SGs) are a digital method that promotes learning through playability. DOSE is a SG that aims to improve the use and navigation of the British National Formulary, a standard medicines reference source. This research aimed to design and examine the playability and perceptions of DOSE within healthcare curricula.
Education on Preventing Early Childhood Injuries Using a Video Game: The VirtualSafeHome Platform. [2023]Poisonings and household injuries are frequent events among toddlers. We developed VirtualSafeHome (VSH)-a novel self-contained, Internet-based home-safety learning tool-to improve awareness of household hazards. Study aims were to investigate VSH usage characteristics. A prototype, screen-based VSH kitchen was built in Unity and delivered through the web using 3DVista and Wix. Players spot and click 21 embedded hazards. A unique feature is the ability to capture the "child's perspective" in identifying hazards. We recruited a convenience sample of adults in 2021-2022. Outcomes included number of hazards discovered, session duration, and pretest/posttest knowledge scores. Twenty-four adults identified a median 15.5 hazards; median playing time was 1022 seconds. Players reported satisfaction with ease of navigation and game features. Mean pretest/posttest knowledge scores rose from 2.0 to 2.79 (P < .035). A web-enabled video game can provide easily accessed, enjoyable training on home safety.
Nurseped: educational technology for safety in the management of intravenous antibiotics in pediatrics. [2023]to develop and validate the content of a serious game on the safe management of intravenous medications in pediatrics.