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NCT Number: NCT05838638

Serious Gaming for Chemotherapy-induced Nausea and Vomiting

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.

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Key information

Conditions

Neoplasms Chemically-Induced Disorders Chemotherapy-induced Nausea and Vomiting Drug-Related Side Effects and Adverse Reactions Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miller School of Medicine Sylvester Comp. Cancer Center, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eSSET-CINV

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.

Other names: Managing at Home- CINV

Primary outcomes

  1. Healthcare resource use

    Time frame: From baseline through the end of the study at 12 or 24 weeks

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

  2. CINV severity

    Time frame: From baseline1 through the end of the study at 12 or 24 weeks

    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 outcomes

  1. Self-management behaviors

    Time frame: From baseline through the end of the study at 12 or 24 weeks

    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.

  2. Symptom severity

    Time frame: Baseline and 12 or 24 weeks

    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

  3. Cognitive representation

    Time frame: Baseline and 12 or 24 weeks

    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.

  4. Health-related Quality of Life

    Time frame: baseline, 4,8,12,16,20, and 24 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Owings

CONTACT

[email protected]

407-440-1309

Victoria Loerzel, PhD

CONTACT

[email protected]

407-823-0762

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • Orlando Health, Inc.
  • University of Miami

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 1, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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