NeoplasmsNCT05838638
Serious Gaming for Chemotherapy-induced Nausea and Vomiting
A study testing eSSET-CINV in people with Neoplasms and Chemotherapy-induced Nausea and Vomiting, run by University of Central Florida at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Neoplasms, Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- eSSET-CINV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jun 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- previous diagnosis and/or treatment for cancer
- end stage disease with less than 6 months to live
- visually or hearing impaired without corrective device
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Miller School of Medicine Sylvester Comp. Cancer Center
Miami, Florida, 33136
Deborah Anglade, PhD, d.anglade@miami.edu
- Recruiting
Orlando Health
Orlando, Florida, 32806
Aurea Middleton, MSN, aurea.middleton@orlandohealth.com
Aurea Middleton, MSN
About this study
Official title: 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.
Read the 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.
- Being tested
- eSSET-CINV
- Keywords
- aged, digital technology, nausea, neoplasm, Drug related side effects and adverse reactions, self-management
- Medical subject headings
- Neoplasms, Vomiting, Nausea, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSSET-CINVBehavioural
Also called Managing at Home- 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Behavioral: eSSET-CINV |
| Control | Active comparator | 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 Receives: Behavioral: eSSET-CINV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare resource use
any emergency department or hospital admission will be recorded using a dichotomous variable (yes/no)
Measured: 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.
Measured: From baseline1 through the end of the study at 12 or 24 weeks
Secondary outcomes (4)
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.
Measured: From baseline through the end of the study at 12 or 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
Measured: 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.
Measured: Baseline and 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
Measured: baseline, 4,8,12,16,20, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start9 Jun 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either an intervention or control group.
- Masking
- None (open label)
- Enrolment
- 610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Orlando Health, Inc., University of Miami, National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Victoria Loerzel, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838638
- Sponsor's protocol ID
- 00003808
- Other IDs
- R01NR020003
- Status last verified
- May 2025
- First submitted
- 20 Apr 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27271365Loerzel 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 29422160Loerzel 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 34105026Wochna 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 32830802Loerzel 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 39357051
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serious Gaming for Chemotherapy-induced Nausea and Vomiting in Older Adults With Cancer: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05838638
- Acronym / sponsor ID
- 00003808
- Keywords
- aged, digital technology, nausea, neoplasm, Drug related side effects and adverse reactions, self-management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- Orlando Health, Inc., University of Miami, National Institute of Nursing Research (NINR)
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either an intervention or control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: eSSET-CINVThis 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 |
| Control | Active comparator | Behavioral: eSSET-CINVThe 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- previous diagnosis and/or treatment for cancer
- end stage disease with less than 6 months to live
- visually or hearing impaired without corrective device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eSSET-CINVAlso: Managing at Home- CINVParticipants 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. | Behavioural | Control, Intervention |
Primary outcome
Healthcare resource use
Time frame: From baseline through the end of the study at 12 or 24 weeks
any emergency department or hospital admission will be recorded using a dichotomous variable (yes/no)
CINV severity
Time frame: From baseline1 through the end of the study at 12 or 24 weeks
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 27271365Loerzel 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.
- Background: PubMed 29422160Loerzel 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.
- Background: PubMed 34105026Loerzel 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.
- Background: PubMed 32830802Wochna 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.
- Derived from this study: PubMed 39357051Loerzel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victoria Loerzel, PhD principal investigator
University of Central Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eSSET-CINV in people with Neoplasms and Chemotherapy-induced Nausea and Vomiting, run by University of Central Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria Loerzel, PhD (407-823-0762, victoria.loerzel@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare resource use (time frame: From baseline through the end of the study at 12 or 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05838638, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.