Serious Gaming for Chemotherapy-induced Nausea and Vomiting
- Conditions
- NeoplasmsChemotherapy-induced Nausea and Vomiting
- Interventions
- Behavioral: eSSET-CINV
- Registration Number
- NCT05838638
- Lead Sponsor
- University of Central Florida
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 610
- 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
- previous diagnosis and/or treatment for cancer
- end stage disease with less than 6 months to live
- visually or hearing impaired without corrective device
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control 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 Intervention eSSET-CINV 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
- Primary Outcome Measures
Name Time Method CINV severity From baseline1 through the end of the study at 12 or 24 weeks 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.
Healthcare resource use From baseline through the end of the study at 12 or 24 weeks any emergency department or hospital admission will be recorded using a dichotomous variable (yes/no)
- Secondary Outcome Measures
Name Time Method Health-related Quality of Life baseline, 4,8,12,16,20, and 24 weeks The EORTC-30 will measure quality of life at each treatment cycle. Higher scores mean better quality of life
Self-management behaviors From baseline through the end of the study at 12 or 24 weeks 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.
Symptom severity Baseline and 12 or 24 weeks 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
Cognitive representation Baseline and 12 or 24 weeks 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.
Trial Locations
- Locations (2)
Miller School of Medicine Sylvester Comp. Cancer Center
🇺🇸Miami, Florida, United States
Orlando Health
🇺🇸Orlando, Florida, United States