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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR020003 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Orlando Health, Inc. | OTHER |
| University of Miami | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eSSET-CINV | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Loerzel, PhD | Contact | 407-823-0762 | victoria.loerzel@ucf.edu | |
| Michael Owings | Contact | 407-440-1309 | michaelowings@ucf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Victoria Loerzel, PhD | University of Central Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miller School of Medicine Sylvester Comp. Cancer Center | Recruiting | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27271365 | Background | 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. | |
| 29422160 | Background | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D014839 | Vomiting |
| D009325 | Nausea |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064419 | Chemically-Induced Disorders |
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Participants will be randomly assigned to either an intervention or control group.
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| 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 |
| 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 |
| Orlando Health | Recruiting | Orlando | Florida | 32806 | United States |
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| 34105026 | Background | 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. |
| 32830802 | Background | 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. |
| 39357051 | Derived | 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. |