Using digital technology to manage chemotherapy-related nausea and vomiting in older adults
Serious Gaming for Chemotherapy-induced Nausea and Vomiting in Older Adults With Cancer: A Randomized Clinical Trial
NA · University of Central Florida · NCT05838638
This study is testing a digital program to help older adults manage nausea and vomiting while they go through chemotherapy to see if it improves their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 610 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Central Florida (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT05838638 on ClinicalTrials.gov |
What this trial studies
This study examines the effectiveness of a technology-based intervention aimed at managing nausea and vomiting in older adults undergoing chemotherapy. Participants will be randomly assigned to either an intervention group, which will receive the eSSET-CINV program, or a control group. The study will assess outcomes such as symptom severity, quality of life, and healthcare resource utilization over the course of 6 chemotherapy cycles, which may last between 12 to 24 weeks. The goal is to enhance self-management behaviors to reduce negative health outcomes and hospital admissions related to chemotherapy side effects.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 60 or older who are newly diagnosed with cancer and undergoing chemotherapy with moderate to high emetic potential.
Not a fit: Patients with a previous cancer diagnosis or those with end-stage disease are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for older cancer patients by effectively managing chemotherapy-induced nausea and vomiting.
How similar studies have performed: Other studies have shown promise in using technology-based interventions for symptom management in cancer patients, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * previous diagnosis and/or treatment for cancer * end stage disease with less than 6 months to live * visually or hearing impaired without corrective device
Where this trial is running
Miami, Florida and 1 other locations
- Miller School of Medicine Sylvester Comp. Cancer Center — Miami, Florida, United States (RECRUITING)
- Orlando Health — Orlando, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Victoria Loerzel, PhD — University of Central Florida
- Study coordinator: Victoria Loerzel, PhD
- Email: victoria.loerzel@ucf.edu
- Phone: 407-823-0762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neoplasms, Chemotherapy-induced Nausea and Vomiting, aged, digital technology, nausea, neoplasm, Drug related side effects and adverse reactions, self-management