Serious Gaming for Chemotherapy-induced Nausea and Vomiting

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05838638
• Other study ID #: 00003808
• Secondary ID: R01NR020003
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: May 2024
• Source: University of Central Florida
• Contact: Victoria Loerzel, PhD
• Phone: 407-823-0762
• Email: victoria.loerzel[@]ucf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 610
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Neoplasms
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
United States	Miller School of Medicine Sylvester Comp. Cancer Center	Miami	Florida
United States	Orlando Health	Orlando	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of Central Florida	National Institute of Nursing Research (NINR), Orlando Health, Inc., University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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