Serious Gaming for Chemotherapy-induced Nausea and Vomiting

University of Central Florida

Status: Enrolling

Conditions: Neoplasms; Chemotherapy-induced Nausea and Vomiting

Treatments: Behavioral: eSSET-CINV

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05838638

00003808

R01NR020003 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 610 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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610 participants in 2 patient groups

Intervention

Experimental group

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

Treatment:

Behavioral: eSSET-CINV

Control

Active Comparator group

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

Treatment:

Behavioral: eSSET-CINV