Serious Gaming for Chemotherapy-induced Nausea and Vomiting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Neoplasms, Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
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* Behavioral: eSSET-CINV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to either an intervention or control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>* Other names: Managing at Home- CINV;|
| Active Comparator: Control<br>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<br>* 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.<br>* Other names: Managing at Home- CINV;|

What is the study measuring?
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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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aged, digital technology, nausea, neoplasm, Drug related side effects and adverse reactions, self-management