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Trial Title:
Serious Gaming for Chemotherapy-induced Nausea and Vomiting
NCT ID:
NCT05838638
Condition:
Neoplasms
Chemotherapy-induced Nausea and Vomiting
Conditions: Official terms:
Nausea
Vomiting
Conditions: Keywords:
aged
digital technology
nausea
neoplasm
Drug related side effects and adverse reactions
self-management
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Participants will be randomly assigned to either an intervention or control group.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
eSSET-CINV
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.
Arm group label:
Control
Arm group label:
Intervention
Other name:
Managing at Home- CINV
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.
Criteria for 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
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Miller School of Medicine Sylvester Comp. Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Deborah Anglade, PhD
Email:
d.anglade@miami.edu
Facility:
Name:
Orlando Health
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Contact:
Last name:
Aurea Middleton, MSN
Email:
aurea.middleton@orlandohealth.com
Investigator:
Last name:
Aurea Middleton, MSN
Email:
Sub-Investigator
Start date:
June 9, 2023
Completion date:
June 30, 2027
Lead sponsor:
Agency:
University of Central Florida
Agency class:
Other
Collaborator:
Agency:
Orlando Health, Inc.
Agency class:
Other
Collaborator:
Agency:
University of Miami
Agency class:
Other
Collaborator:
Agency:
National Institute of Nursing Research (NINR)
Agency class:
NIH
Source:
University of Central Florida
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05838638
