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Serious Gaming for Chemotherapy-induced Nausea and Vomiting in Older Adults With Cancer: A Randomized Clinical Trial

NCT ID: NCT05838638Sponsor: University of Central FloridaLast updated: 2026-05-01

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.

Arms & interventions

  • BehavioraleSSET-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.

Outcome measures

Primary

  • 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

Secondary

  • Self-management behaviors

    Time frame: From baseline through the end of the study at 12 or 24 weeks

  • Symptom severity

    Time frame: Baseline and 12 or 24 weeks

  • Cognitive representation

    Time frame: Baseline and 12 or 24 weeks

  • Health-related Quality of Life

    Time frame: baseline, 4,8,12,16,20, and 24 weeks

Eligibility criteria

Sex: AllAge: 60 Years and olderHealthy volunteers: No
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

Study locations (2)

Miller School of Medicine Sylvester Comp. Cancer Center

Miami, Florida, 33136

Recruiting
Deborah Anglade, PhD · Contact

Orlando Health

Orlando, Florida, 32806

Recruiting
Aurea Middleton, MSN · Contact
Aurea Middleton, MSN · Sub Investigator

References

  • Loerzel V. Cognitive Representation of Treatment-Related Symptoms in Older Adults With Cancer. Cancer Nurs. 2017 May/Jun;40(3):230-236. doi: 10.1097/NCC.0000000000000395.(PubMed)
  • Loerzel V, Clochesy J, Geddie P. Using a community advisory board to develop a serious game for older adults undergoing treatment for cancer. Appl Nurs Res. 2018 Feb;39:207-210. doi: 10.1016/j.apnr.2017.11.030. Epub 2017 Nov 21.(PubMed)
  • Loerzel VW, Hines RB, Deatrick CW, Geddie PI, Clochesy JM. Unplanned emergency department visits and hospital admissions of older adults under treatment for cancer in the ambulatory/community setting. Support Care Cancer. 2021 Dec;29(12):7525-7533. doi: 10.1007/s00520-021-06338-y. Epub 2021 Jun 9.(PubMed)
  • Wochna Loerzel V, Clochesy JM, Geddie PI. Using Serious Games to Increase Prevention and Self-Management of Chemotherapy-Induced Nausea and Vomiting in Older Adults With Cancer. Oncol Nurs Forum. 2020 Sep 1;47(5):567-576. doi: 10.1188/20.ONF.567-576.(PubMed)
  • Loerzel V, Alamian A, Clochesy J, Geddie PI. Serious Gaming for Chemotherapy-Induced Nausea and Vomiting in Older Adults With Cancer: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2024 Oct 2;13:e64673. doi: 10.2196/64673.(PubMed)
Serious Gaming for Chemotherapy-induced Nausea and Vomiting | Cancerify