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Serious Gaming for Chemotherapy-induced Nausea and Vomiting

Primary Purpose

Neoplasms, Chemotherapy-induced Nausea and Vomiting

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
eSSET-CINV
Sponsored by
University of Central Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neoplasms focused on measuring aged, digital technology, nausea, neoplasm, Drug related side effects and adverse reactions, self-management

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Healthcare resource use
    any emergency department or hospital admission will be recorded using a dichotomous variable (yes/no)
    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.

    Secondary Outcome Measures

    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.
    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
    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.
    Health-related Quality of Life
    The EORTC-30 will measure quality of life at each treatment cycle. Higher scores mean better quality of life

    Full Information

    First Posted
    April 20, 2023
    Last Updated
    May 3, 2023
    Sponsor
    University of Central Florida
    Collaborators
    Orlando Health, Inc., University of Miami, National Institute of Nursing Research (NINR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05838638
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2027 (Anticipated)
    Study Completion Date
    June 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Central Florida
    Collaborators
    Orlando Health, Inc., University of Miami, National Institute of Nursing Research (NINR)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neoplasms, Chemotherapy-induced Nausea and Vomiting
    Keywords
    aged, digital technology, nausea, neoplasm, Drug related side effects and adverse reactions, self-management

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomly assigned to either an intervention or control group.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    610 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    eSSET-CINV
    Other Intervention Name(s)
    Managing at Home- CINV
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Healthcare resource use
    Description
    any emergency department or hospital admission will be recorded using a dichotomous variable (yes/no)
    Time Frame
    From baseline through the end of the study at 12 or 24 weeks
    Title
    CINV severity
    Description
    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.
    Time Frame
    From baseline1 through the end of the study at 12 or 24 weeks
    Secondary Outcome Measure Information:
    Title
    Self-management behaviors
    Description
    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.
    Time Frame
    From baseline through the end of the study at 12 or 24 weeks
    Title
    Symptom severity
    Description
    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
    Time Frame
    Baseline and 12 or 24 weeks
    Title
    Cognitive representation
    Description
    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.
    Time Frame
    Baseline and 12 or 24 weeks
    Title
    Health-related Quality of Life
    Description
    The EORTC-30 will measure quality of life at each treatment cycle. Higher scores mean better quality of life
    Time Frame
    baseline, 4,8,12,16,20, and 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Victoria Loerzel, PhD
    Phone
    407-823-0762
    Email
    victoria.loerzel@ucf.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Owings
    Phone
    407-440-1309
    Email
    michaelowings@ucf.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Victoria Loerzel, PhD
    Organizational Affiliation
    University of Central Florida
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27271365
    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.
    Results Reference
    background
    PubMed Identifier
    29422160
    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.
    Results Reference
    background
    PubMed Identifier
    34105026
    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.
    Results Reference
    background
    PubMed Identifier
    32830802
    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.
    Results Reference
    background

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    Serious Gaming for Chemotherapy-induced Nausea and Vomiting

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