Clinical trial NCT05838638: Serious Gaming for Chemotherapy-induced Nausea and Vomiting
Official title: Serious Gaming for Chemotherapy-induced Nausea and Vomiting in Older Adults With Cancer: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Chemotherapy-induced Nausea and Vomiting
Keywords: aged
digital technology
nausea
neoplasm
Drug related side effects and adverse reactions
self-management
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: Orlando Health, Inc.
name: University of Miami
name: National Institute of Nursing Research (NINR)
First posted: 2023-05-01
Enrollment: 610
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either an intervention or control group.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Healthcare resource use
timeFrame: From baseline through the end of the study at 12 or 24 weeks
measure: CINV severity
timeFrame: From baseline1 through the end of the study at 12 or 24 weeks
Secondary outcomes:
measure: Self-management behaviors
timeFrame: From baseline through the end of the study at 12 or 24 weeks
measure: Symptom severity
timeFrame: Baseline and 12 or 24 weeks
measure: Cognitive representation
timeFrame: Baseline and 12 or 24 weeks
measure: Health-related Quality of Life
timeFrame: baseline, 4,8,12,16,20, and 24 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miller School of Medicine Sylvester Comp. Cancer Center
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
affiliation: University of Central Florida
name: Victoria Loerzel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.