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Behavioral Intervention

Serious Gaming for Nausea and Vomiting

N/A
Recruiting
Led By Victoria Loerzel, PhD
Research Sponsored by University of Central Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
age 60 or older
newly diagnosed with cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4,8,12,16,20, and 24 weeks
Awards & highlights

Summary

"This trial aims to see if a technology-based approach can help older adults with cancer better manage nausea and vomiting. Participants will be divided into two groups - one receiving the intervention and the other not. The

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since 'eSSET-CINV' is an intervention rather than a drug, traditional side effects associated with medications may not apply. However, participants might experience discomfort from using new technology or frustration if technical issues arise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 years old or older.
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I have recently been diagnosed with cancer.
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I am currently on or have been treated with chemotherapy that often causes vomiting.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4,8,12,16,20, and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4,8,12,16,20, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CINV severity
Healthcare resource use
Secondary study objectives
Cognitive representation
Health-related Quality of Life
Self-management behaviors
+1 more

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
eSSET-CINV
2016
N/A
~80

Find a Location

Who is running the clinical trial?

National Institute of Nursing Research (NINR)NIH
598 Previous Clinical Trials
10,377,552 Total Patients Enrolled
University of MiamiOTHER
935 Previous Clinical Trials
421,607 Total Patients Enrolled
University of Central FloridaLead Sponsor
87 Previous Clinical Trials
1,098,991 Total Patients Enrolled
~407 spots leftby Jun 2027
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