Chemotherapy-induced Nausea and Vomiting, Neoplasms
Conditions
Keywords
aged, digital technology, nausea, neoplasm, Drug related side effects and adverse reactions, self-management
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.
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.
Interventions
BEHAVIORALeSSET-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.
Sponsors
University of Central Florida
Orlando Health, Inc.
University of Miami
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be randomly assigned to either an intervention or control group.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare resource use | 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) |
| CINV severity | 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
| Measure | Time frame | Description |
|---|---|---|
| Self-management behaviors | 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. |
| Symptom severity | 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 |
| Cognitive representation | 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. |
| Health-related Quality of Life | 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 |
Countries
United States
Contacts
CONTACTVictoria Loerzel, PhD
CONTACTMichael Owings
PRINCIPAL_INVESTIGATORVictoria Loerzel, PhD
University of Central Florida
Outcome results
None listed