Serious Gaming for Chemotherapy-induced Nausea and Vomiting

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

Study Overview

• Status: Not yet recruiting
• Conditions: Neoplasms; Chemotherapy-induced Nausea and Vomiting
• Intervention / Treatment: Behavioral: eSSET-CINV

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.

• Study Type: Interventional
• Enrollment (Anticipated): 610
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria Loerzel, PhD; Phone Number: 407-823-0762; Email: victoria.loerzel@ucf.edu
• Study Contact Backup: Name: Michael Owings; Phone Number: 407-440-1309; Email: michaelowings@ucf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.; Other Names: Managing at Home- CINV
Active Comparator: Control; 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.; Other Names: Managing at Home- CINV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare resource use	any emergency department or hospital admission will be recorded using a dichotomous variable (yes/no)	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.	From baseline1 through the end of the study at 12 or 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline through the end of the study at 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	baseline, 4,8,12,16,20, and 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	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.	Baseline and 12 or 24 weeks

Collaborators and Investigators

• Sponsor: University of Central Florida
• Collaborators: University of Miami; National Institute of Nursing Research (NINR); Orlando Health, Inc.
• Investigators: Principal Investigator: Victoria Loerzel, PhD, University of Central Florida

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): June 30, 2027
• Study Completion (Anticipated): June 30, 2027

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: digital technology; self-management; nausea; aged; neoplasm; Drug related side effects and adverse reactions
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: 00003808; R01NR020003 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No