Serious Gaming for Chemotherapy-induced Nausea and Vomiting
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Central Florida
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
previous diagnosis and/or treatment for cancer
end stage disease with less than 6 months to live
visually or hearing impaired without corrective device
Trial design
Design model
Parallel
Treatments tested in this trial
eSSET-CINV
BehavioralParticipants 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.
Treatment groups
610 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Healthcare resource use
any emergency department or hospital admission will be recorded using a dichotomous variable (yes/no)
Time frame
From baseline through the end of the study at 12 or 24 weeks2
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.
Time frame
From baseline1 through the end of the study at 12 or 24 weeksSecondary outcomes
1
Self-management behaviors
The Symptom Management Checklist will measure self-management behaviors and preventive behaviors for CINV. 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.
Time frame
From baseline through the end of the study at 12 or 24 weeks2
Symptom severity
The Symptom Representation Questionnaire Part 1 is a 24 item self-report measure that will be used to identify the presence and severity of common treatment-related side effects (0 to 10 scale). Higher numbers indicate more severe symptoms. This measure asks participants to think about their symptoms over the last week
Time frame
Baseline and 12 or 24 weeks3
Cognitive representation
The Symptom Representation Questionnaire Part 2 has 15 questions related to cognitive beliefs about nausea. Sub scales examine symptom cause, timeline, cure/control, and consequences. An agreement type Likert scale is used.
Time frame
Baseline and 12 or 24 weeks4
Health-related Quality of Life
The EORTC-30 will measure quality of life at each treatment cycle. Higher scores mean better quality of life
Time frame
baseline, 4,8,12,16,20, and 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Central Florida
Lead sponsor
Orlando Health, Inc.
Collaborator
University of Miami
Collaborator
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov