An interventional study of eSSET-CINV in Neoplasms and Chemotherapy-induced Nausea and Vomiting, sponsored by University of Central Florida. Recruiting at 2 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Central Florida · Not applicable, Interventional, and Supportive care
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.
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 610 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Central Florida is the lead sponsor of 104 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Behavioral: eSSET-CINV
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
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.
Also known as: Managing at Home- CINV
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 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.
Time frame: From baseline1 through the end of the study at 12 or 24 weeks
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 weeks
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 weeks
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 weeks
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 weeks
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Central Florida →