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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4,8,12,16,20, and 24 weeks

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met