Serious Gaming for Chemotherapy-induced Nausea and Vomiting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: eSSET-CINV.
- Who it may be relevant to
- Registry conditions: Neoplasms, Chemotherapy-induced Nausea and Vomiting. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Serious Gaming for Chemotherapy-induced Nausea and Vomiting in Older Adults With Cancer: A Randomized Clinical Trial
Overview
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.
Detailed description
The goal of this study is to increase the use of preventative self-management behaviors for nausea and vomiting in older adults receiving chemotherapy to reduce negative outcomes and emergency or hospital admissions. Early reinforcement of standard education and re-framing any preconceived beliefs about the ability of nausea and vomiting to be managed will increase preventative self-management behaviors and improve patient outcomes. Participants will be in the study for 6 chemotherapy treatment cycles. This could be 12 to 24 weeks depending on if they receive treatment every 2, 3 or 4 weeks.
Interventions
- Behavioral eSSET-CINV
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.
Primary outcome measures
- Healthcare resource use [Time frame: From baseline through the end of the study at 12 or 24 weeks]
- CINV severity [Time frame: From baseline1 through the end of the study at 12 or 24 weeks]
Secondary outcome measures (4)
- Self-management behaviors [Time frame: From baseline through the end of the study at 12 or 24 weeks]
- Symptom severity [Time frame: Baseline and 12 or 24 weeks]
- Cognitive representation [Time frame: Baseline and 12 or 24 weeks]
- Health-related Quality of Life [Time frame: baseline, 4,8,12,16,20, and 24 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- previous diagnosis and/or treatment for cancer
- end stage disease with less than 6 months to live
- visually or hearing impaired without corrective device
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Miller School of Medicine Sylvester Comp. Cancer Center — Miami
- Orlando Health — Orlando
Publications
- 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 27271365
- Loerzel 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 29422160
- Loerzel 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 34105026
- Wochna 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 32830802
- Loerzel 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 39357051
Identifiers
NCT: NCT05838638 · 00003808 · R01NR020003