Serious Gaming for Nausea and Vomiting

Recruiting at 1 trial location

Overseen By Michael Owings

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Central Florida

Disqualifiers: Previous cancer, End stage disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

610 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a fun, game-based approach to help older adults with cancer manage chemotherapy-induced nausea and vomiting. Participants will divide into two groups: one will use a "serious game" called eSSET-CINV to practice self-care decisions, while the other will receive standard education and later try the game. The trial aims to determine if the game improves symptoms, quality of life, and healthcare resource use. It suits those aged 60 or older, newly diagnosed with cancer, and undergoing certain chemotherapy treatments. As an unphased trial, this study offers a unique opportunity to explore innovative ways to enhance quality of life during treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technology-based intervention is safe for managing nausea and vomiting in older adults with cancer?

Research shows that using serious games like eSSET-CINV as a treatment is generally safe and well-tolerated. Serious games are digital games or apps designed for more than just fun; in this case, they help older adults with cancer manage nausea and vomiting from chemotherapy.

Although specific studies on safety issues with eSSET-CINV are lacking, serious games used in healthcare have a good safety record. They don't involve drugs or surgery, which usually means fewer side effects, making them a low-risk option for patients.

For those considering joining the trial, the absence of known side effects and the non-invasive nature of the treatment suggest it is a safe choice. However, as with any treatment, discussing any concerns with the research team or a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the eSSET-CINV approach because it offers a novel, interactive way to manage nausea and vomiting in cancer patients. Unlike standard treatments, which typically involve medications like antiemetics to alleviate symptoms, eSSET-CINV uses a serious gaming platform. This game helps older adults make self-care decisions through an engaging avatar experience that mirrors their real-life challenges post-chemotherapy. By coupling this with in-depth discussions, the approach aims to empower patients with practical skills and knowledge to manage their symptoms effectively at home. This innovative blend of technology and education could enhance patient engagement and improve outcomes beyond what traditional methods offer.

What evidence suggests that this serious game is effective for managing nausea and vomiting in older adults with cancer?

Research shows that serious games, such as the eSSET-CINV program, can help manage nausea and vomiting caused by chemotherapy. In this trial, participants in the intervention arm will use the eSSET-CINV game, which enables older adults to practice self-care decisions through a virtual character. This method aims to enhance their ability to manage symptoms after chemotherapy. Early studies suggest that these interactive tools aid in symptom management. However, further research is needed to confirm their effectiveness. ^{1 2 4 6 7}

Who Is on the Research Team?

Victoria Loerzel, PhD

Principal Investigator

University of Central Florida

Are You a Good Fit for This Trial?

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

proficient in English

I am 60 years old or older.

I have recently been diagnosed with cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy Treatment

Participants receive chemotherapy treatment cycles, with the intervention group using a serious game for self-management of nausea and vomiting

12-24 weeks

6 cycles, every 2, 3, or 4 weeks

Follow-up

Participants are monitored for healthcare resource use, CINV severity, self-management behaviors, symptom severity, cognitive representation, and health-related quality of life

12-24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• eSSET-CINV

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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: Control Active Control 1 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

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials

101

Recruited

1,191,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Orlando Health, Inc.

Collaborator

Trials

32

Recruited

15,100+

Published Research Related to This Trial

Over 80% of participants experienced nausea, disorientation, or oculomotor disturbances after using immersive virtual environment technology for 15 to 60 minutes, indicating a high risk of adverse effects.

12.9% of participants had to stop their exposure early due to these adverse effects, suggesting that designers can improve user safety by limiting exposure time and simplifying navigational controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What to expect from immersive virtual environment exposure: influences of gender, body mass index, and past experience. Stanney, KM., Hale, KS., Nahmens, I., et al.[2017]

Health-based games have the potential to serve as effective therapeutic interventions for chronic diseases, but there is currently a lack of robust evidence supporting their clinical use.

To enhance the efficacy and adoption of health games, a structured approach is needed, including the development of a global language for game design, multidisciplinary teams, specialized game engines, and rigorous trial methodologies to assess their clinical impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision gaming for health: Computer games as digital medicine. Kinross, JM.[2019]

In a study involving 80 adults aged 60 and older with newly diagnosed cancer, those using an electronic serious game reported more preventive behaviors against chemotherapy-induced nausea and vomiting (CINV) compared to a control group, who focused more on self-management strategies.

Participants found the serious game highly usable and acceptable, suggesting it could be an effective tool for oncology providers to help older adults manage treatment-related side effects at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Serious Games to Increase Prevention and Self-Management of Chemotherapy-Induced Nausea and Vomiting in Older Adults With Cancer. Wochna Loerzel, V., Clochesy, JM., Geddie, PI.[2021]

The serious game DOSE was validated for playability and functionality, with 95% of pharmacy students expressing a desire to use it again, indicating its effectiveness as a learning tool.

Nursing students reported a significant increase in confidence using the British National Formulary (BNF) after playing DOSE, with 84% wanting it integrated into their curriculum, highlighting its positive impact on pharmacology knowledge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of a serious game to support learning among pharmacy and nursing students. Kayyali, R., Wells, J., Rahmtullah, N., et al.[2021]

The VirtualSafeHome (VSH) tool effectively increased awareness of household hazards among adults, with participants identifying a median of 15.5 hazards during gameplay.

Participants showed a significant improvement in safety knowledge, with pretest scores rising from 2.0 to 2.79 after using the VSH, indicating that this engaging, web-based game can be a valuable resource for home safety education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education on Preventing Early Childhood Injuries Using a Video Game: The VirtualSafeHome Platform. Woolf, AD., Jacobson, J., Flanagan, S., et al.[2023]

The implementation of a computer-based straw-drinking game as a reinforcement strategy in dysphagia therapy showed a trend towards increased endurance and comfort in a school-age child with feeding difficulties, allowing for more practice opportunities during sessions.

Despite some improvements, the child's average daily oral intake remained low (less than 30 ml), and factors like fatigue and anxiety continued to hinder significant progress in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of a Novel Gaming Reinforcement System on Oral Intake Outcomes in Pediatric Feeding Therapy: A Single Case Study. Budhan, J., Scarborough, D., Kuren, MB.[2020]

Playing commercial console video games using a head-mounted display can lead to motion sickness, especially when players are standing, as observed in a study with varying postures and game types.

Seated players showed differences in head motion before experiencing motion sickness, suggesting that instability in posture control may contribute to the onset of symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motion sickness, console video games, and head-mounted displays. Merhi, O., Faugloire, E., Flanagan, M., et al.[2017]

The Pediatric Nausea Assessment Tool (PeNAT) was developed and validated for children aged 4-18 years, demonstrating significant differences in nausea scores among various patient groups, including those undergoing chemotherapy.

The PeNAT showed moderate reliability and validity, correlating well with parental assessments of nausea, making it a useful tool for accurately measuring nausea intensity in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of the pediatric nausea assessment tool for use in children receiving antineoplastic agents. Dupuis, LL., Taddio, A., Kerr, EN., et al.[2022]

The redesigned Schisto and Ladders game significantly increased children's awareness of praziquantel treatment, with 67.9% of participants in the intervention group knowing about it after playing, compared to only 1.1% in the control group.

The game also effectively encouraged treatment compliance, as 65.3% of children in the intervention group sought praziquantel treatment after the trial, demonstrating its potential as a health education tool in schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Schisto and Ladders version 2: a health educational board game to support compliance with school-based mass drug administration with praziquantel - a pilot study. Ejike, CU., Oluwole, AS., Omitola, OO., et al.[2021]

A community advisory board of older adults and caregivers was crucial in developing a serious game aimed at helping manage chemotherapy-induced nausea and vomiting (CINV), ensuring the game's content was relevant and reflective of their real experiences.

The formative evaluation process highlighted the importance of older adults' perspectives in creating educational tools, suggesting that serious gaming could effectively enhance symptom self-management education for this age group, which traditional methods may not adequately address.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a community advisory board to develop a serious game for older adults undergoing treatment for cancer. Loerzel, V., Clochesy, J., Geddie, P.[2019]

A serious game called Nurseped was developed to educate healthcare professionals on the safe management of intravenous medications for pediatric patients, focusing on commonly used antibiotics and patient safety.

The game's content was validated by 11 experienced nurses, achieving a high agreement rate of 98.4% on the relevance of the material, ensuring that it is both accurate and effective for training purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurseped: educational technology for safety in the management of intravenous antibiotics in pediatrics. Alves, APB., Aredes, NDA., Silva, GO., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39357051/

Serious Gaming for Chemotherapy-Induced Nausea and ... Methods: This is a longitudinal randomized clinical trial. We will collect data from 500 older adults receiving cancer-related chemotherapy at ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11483260/

Serious Gaming for Chemotherapy-Induced Nausea and ... This is a longitudinal randomized clinical trial. We will collect data from 500 older adults receiving cancer-related chemotherapy at baseline ( ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05838638

Serious Gaming for Chemotherapy-induced Nausea and Vomiting 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.

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/484355

Serious Gaming for Chemotherapy-induced Nausea and Vomiting 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.

5. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R01NR020003&arg_ProgOfficeCode=136

Award Information | HHS TAGGS Serious gaming for chemotherapy-induced nausea and vomiting in older adults with cancer: A randomized clinical trial · Award Number: R01NR020003 · ORGANIZATION: ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0897189717304007

Using a community advisory board to develop a serious ... Older adults undergoing treatment for cancer are at risk for serious complications such as chemotherapy-induced nausea and vomiting (CINV).

7. researchgate.net researchgate.net/publication/384571655_Serious_Gaming_for_Chemotherapy-Induced_Nausea_and_Vomiting_in_Older_Adults_With_Cancer_Protocol_for_a_Randomized_Clinical_Trial_Preprint

Protocol for a Randomized Clinical Trial (Preprint) Serious Gaming for Chemotherapy-Induced Nausea and Vomiting in Older Adults ... We will collect data from 500 older adults receiving cancer-related chemotherapy ...