Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 23, 2024
Date Accepted: Aug 8, 2024
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Serious Gaming for Chemotherapy Induced Nausea and Vomiting in Older Adults with Cancer: Protocol for a Randomized Clinical Trial
ABSTRACT
Background:
Older adults are at high risk for toxicity due to cancer treatment and increased risk for adverse events related to chemotherapy-induced nausea and vomiting (CINV). Unfortunately, older adults report multiple treatment-related symptoms, but use few strategies to self-manage these symptoms due to erroneous beliefs related to the effectiveness of commonly taught self-management strategies. We developed a novel serious game, MAH, to help older adults learn how to effectively self-manage chemotherapy-induce nausea and vomiting at home.
Objective:
This study has 2 aims. Aim 1 is to Examine changes in CINV severity, self-management behaviors, functioning, QOL, cognitive representation and healthcare use within the intervention group from baseline (T1) to completion of the study (T6). Aim 2 is to determine efficacy of the Managing at Home (MAH) intervention by comparing differences in primary outcomes (CINV severity, healthcare use) and secondary outcomes (self-management behaviors, functioning, and QOL) between the intervention and control groups at each follow-up visit (T2-T6) and completion of the study (T6).
Methods:
This is a longitudinal randomized clinical trial. We will collect data from 500 older adults receiving cancer-related chemotherapy at baseline (T1) and at each treatment cycle until cycle 6 (T6). Participants will be enrolled if they are age 60 or older, newly diagnosed with cancer, being treated with any chemotherapy agent with moderate or high emetic potential, on a 2-, 3-, or 4-week treatment cycle, are proficient in English and have a telephone. Previous diagnosis and/or treatment for cancer, end-stage disease with less than 6 months to live, and uncorrected visual or hearing impairment are exclusion criteria.
Results:
As of July 2023, the enrollment of participants is ongoing.
Conclusions:
This study addresses self-management of CINV in older adults using an innovative serious game. The MAH intervention uses simulation and gaming technology to engage older adults in active learning in order to reframe erroneous perceptions about symptom self-management. If shown to be effective, it can easily be adapted to include other cancer-related symptoms and/or other chronic illnesses. Clinical Trial: ClinicalTrials.gov NCT05838638; https://clinicaltrials.gov/study/NCT05838638?term=NCT05838638&rank=1
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