Serious Gaming for Chemotherapy-induced Nausea and Vomiting
2 other identifiers
interventional
610
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedStudy Start
First participant enrolled
June 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
May 1, 2026
May 1, 2025
4.1 years
April 20, 2023
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Healthcare resource use
any emergency department or hospital admission will be recorded using a dichotomous variable (yes/no)
From baseline through the end of the study at 12 or 24 weeks
CINV severity
The Symptom Management Checklist will measure the presence and severity of nausea and vomiting. Participants will be sent a text link every day for 6 days after chemotherapy or complete this data on a form at home. This starts right after time 1. Nausea will be reported on a 0-10 scale. Higher numbers equal more nausea.
From baseline1 through the end of the study at 12 or 24 weeks
Secondary Outcomes (4)
Self-management behaviors
From baseline through the end of the study at 12 or 24 weeks
Symptom severity
Baseline and 12 or 24 weeks
Cognitive representation
Baseline and 12 or 24 weeks
Health-related Quality of Life
baseline, 4,8,12,16,20, and 24 weeks
Study Arms (2)
Intervention
EXPERIMENTALThis 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
Control
ACTIVE COMPARATORThe 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
Interventions
Participants in the intervention group will be asked to play the serious game on an iPad at their first chemotherapy treatment visit. The control group will be able to play at time 6.
Eligibility Criteria
You may qualify if:
- age 60 or older
- newly diagnosed with cancer
- treatment with any chemotherapeutic agent of moderate or high emetic potential
- on a 2, 3 or 4 week treatment cycle
- proficient in English
- has a telephone
You may not qualify if:
- previous diagnosis and/or treatment for cancer
- end stage disease with less than 6 months to live
- visually or hearing impaired without corrective device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Orlando Health, Inc.collaborator
- University of Miamicollaborator
- University of Central Floridalead
- National Institute of Nursing Research (NINR)collaborator
Study Sites (2)
Miller School of Medicine Sylvester Comp. Cancer Center
Miami, Florida, 33136, United States
Orlando Health
Orlando, Florida, 32806, United States
Related Publications (5)
Loerzel V. Cognitive Representation of Treatment-Related Symptoms in Older Adults With Cancer. Cancer Nurs. 2017 May/Jun;40(3):230-236. doi: 10.1097/NCC.0000000000000395.
PMID: 27271365BACKGROUNDLoerzel V, Clochesy J, Geddie P. Using a community advisory board to develop a serious game for older adults undergoing treatment for cancer. Appl Nurs Res. 2018 Feb;39:207-210. doi: 10.1016/j.apnr.2017.11.030. Epub 2017 Nov 21.
PMID: 29422160BACKGROUNDLoerzel VW, Hines RB, Deatrick CW, Geddie PI, Clochesy JM. Unplanned emergency department visits and hospital admissions of older adults under treatment for cancer in the ambulatory/community setting. Support Care Cancer. 2021 Dec;29(12):7525-7533. doi: 10.1007/s00520-021-06338-y. Epub 2021 Jun 9.
PMID: 34105026BACKGROUNDWochna Loerzel V, Clochesy JM, Geddie PI. Using Serious Games to Increase Prevention and Self-Management of Chemotherapy-Induced Nausea and Vomiting in Older Adults With Cancer. Oncol Nurs Forum. 2020 Sep 1;47(5):567-576. doi: 10.1188/20.ONF.567-576.
PMID: 32830802BACKGROUNDLoerzel V, Alamian A, Clochesy J, Geddie PI. Serious Gaming for Chemotherapy-Induced Nausea and Vomiting in Older Adults With Cancer: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2024 Oct 2;13:e64673. doi: 10.2196/64673.
PMID: 39357051DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victoria Loerzel, PhD
University of Central Florida
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2023
First Posted
May 1, 2023
Study Start
June 9, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
May 1, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share