Recruiting

Serious Gaming

Sponsor:

University of Central Florida

Code:

NCT05838638

Conditions

Neoplasms

Chemotherapy-induced Nausea and Vomiting

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

eSSET-CINV

Study Details

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.

Conditions

Neoplasms

Chemotherapy-induced Nausea and Vomiting

Study ID

NCT05838638

Start date

Jun 9, 2023

Status verified date

May, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

610 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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

active comparator: 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

Interventions

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.

Primary outcome measure

  • Healthcare resource use [ Time Frame: From baseline through the end of the study at 12 or 24 weeks ]
  • CINV severity [ Time Frame: From baseline1 through the end of the study at 12 or 24 weeks ]

Central Contacts and Locations

Central contacts

Victoria Loerzel, PhD

407-823-0762victoria.loerzel@ucf.edu

Michael Owings

407-440-1309michaelowings@ucf.edu

Locations

Miller School of Medicine Sylvester Comp. Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Deborah Anglade, PhD

d.anglade@miami.edu

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

Aurea Middleton, MSN

aurea.middleton@orlandohealth.com

More Information

Sponsor

University of Central Florida

Last update posted

May 1, 2026

Last verified

May, 2025

Keywords

  • aged
  • digital technology
  • nausea
  • neoplasm
  • Drug related side effects and adverse reactions
  • self-management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Central Florida on 2026-05-01.