Serious Gaming for Chemotherapy-induced Nausea and Vomiting

NCT ID: NCT05838638

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

610 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-09

Study Completion Date

2027-06-30

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.

Conditions

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Neoplasms Chemotherapy-induced Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to either an intervention or control group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

eSSET-CINV

Intervention Type 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.

Control

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

Group Type ACTIVE_COMPARATOR

eSSET-CINV

Intervention Type 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.

Interventions

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eSSET-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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Managing at Home- CINV

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orlando Health, Inc.

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Central Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victoria Loerzel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Central Florida

Locations

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Miller School of Medicine Sylvester Comp. Cancer Center

Miami, Florida, United States

Site Status RECRUITING

Orlando Health

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Victoria Loerzel, PhD

Role: CONTACT

407-823-0762

Michael Owings

Role: CONTACT

407-440-1309

Facility Contacts

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Deborah Anglade, PhD

Role: primary

Aurea Middleton, MSN

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 27271365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29422160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34105026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32830802 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39357051 (View on PubMed)

Other Identifiers

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R01NR020003

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00003808

Identifier Type: -

Identifier Source: org_study_id

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