Serious Gaming for Nausea and Vomiting

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Victoria Loerzel, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Central Florida

Disqualifiers: Previous cancer, End stage disease, others

No Placebo Group

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.

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 data supports the effectiveness of the treatment eSSET-CINV for nausea and vomiting?

The research suggests that serious games can help older adults manage chemotherapy-induced nausea and vomiting by teaching them self-management strategies, which indicates that eSSET-CINV might be effective in a similar way. ^{1 2 3 4 5}

Is the serious game treatment for nausea and vomiting safe for humans?

There is no specific safety data available for the serious game treatment for nausea and vomiting, but health-based games are generally considered low cost and can be deployed safely at the point of care. However, a robust evidence base for their safety and efficacy as clinical interventions is still lacking. ^{6 7 8 9 10}

How is the eSSET-CINV treatment different from other treatments for nausea and vomiting?

The eSSET-CINV treatment is unique because it uses a serious game to help older adults manage chemotherapy-induced nausea and vomiting (CINV). This approach focuses on teaching and reinforcing self-management strategies through an interactive and engaging platform, which is different from traditional medication-based treatments. ^{1 2 3 5 11}

Research Team

Victoria Loerzel, PhD

Principal Investigator

University of Central Florida

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

proficient in English

I am 60 years old or older.

I have recently been diagnosed with cancer.

Trial Timeline

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

Treatment Details

Interventions

• eSSET-CINV (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Michael Pape

University of Central Florida

Chief Executive Officer since 2015

PhD in Biochemistry from Purdue University, MBA from the University of Chicago Booth School of Business

Dr. James J. Hickman

University of Central Florida

Chief Medical Officer since 2020

MD from University of Central Florida College of Medicine

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Dr. Jessica Gill

National Institute of Nursing Research (NINR)

Chief Medical Officer since 2023

PhD in Nursing from Johns Hopkins University

Dr. Shannon Zenk

National Institute of Nursing Research (NINR)

Chief Executive Officer since 2020

PhD in Urban Planning and Policy Development from Rutgers University

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

Orlando Health, Inc.

Collaborator

Trials

32

Recruited

15,100+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Using a community advisory board to develop a serious game for older adults undergoing treatment for cancer. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Motion sickness, console video games, and head-mounted displays. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

What to expect from immersive virtual environment exposure: influences of gender, body mass index, and past experience. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Development and validation of the pediatric nausea assessment tool for use in children receiving antineoplastic agents. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

Nurseped: educational technology for safety in the management of intravenous antibiotics in pediatrics. [2023]

7. England 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Development and evaluation of a serious game to support learning among pharmacy and nursing students. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Education on Preventing Early Childhood Injuries Using a Video Game: The VirtualSafeHome Platform. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. United States 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. [2020]