Chemotherapy-induced Nausea and Vomiting, Neoplasms
Conditions
Keywords
gerontology, symptom self-management, Chemotherapy-induced Nausea and Vomiting
Brief summary
The purpose of the project is to estimate the effect size of a technology based intervention for older adults with cancer for nausea and vomiting. Participants will be randomized to either an intervention or a wait 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 self-management behaviors for chemotherapy induced nausea and vomiting (CINV) and reduce treatment-related negative outcomes in older adults with cancer. CINV is a common reason for unplanned emergency department and/or hospital admissions in older adults with cancer. Early reinforcement of standard education and reframing preconceived beliefs about the potential serious consequences of CINV and the symptoms ability to be successfully managed will increase effective self-management behaviors and improve patient outcomes
Interventions
OTHEReSSET-CINV
This intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home.
Sponsors
University of South Florida
Orlando Health, Inc.
University of Central Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants are randomly assigned to either an intervention or wait control group. The intervention group receives an educational intervention at the start of the study. The wait control group receives the intervention at the end.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women age 65 and older * newly diagnosed with any cancer * treatment with any chemotherapeutic agent with a moderate to severe emetic potential (on a 3- or 4- week cycle) * proficient in English * have a telephone.
Exclusion criteria
* Patients with previous diagnosis and treatment for cancer * advanced or end stage disease with a palliative intent * visually or hearing impaired.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Severity Change Over Time | assessed at baseline (week 1), week 4,week 7, week 10. differences between groups at week 10 are being reported | Symptom Representation Questionnaire (SRQ)\[20\] , a 24-item self-report measure will be used to identify presence and severity of common treatment-related symptoms (0-10 Likert scale), including nausea and vomiting (N/V). This measure asks respondents to think about their symptoms over the past week. Higher values indicate a worse outcome |
| Self-management Behaviors Over Time | data was assessed at weeks 4,7, 10, the mean number of behaviors (behaviors) combined at each time point is reported | An investigator-developed Symptom Management Checklist (SMC) will measure CINV self-management prevention behaviors. Participants will complete this daily at home between chemotherapy cycles. Higher numbers indicate more frequent management. |
| Health-related Quality of Life Change Over Time | assessed at baseline (week 1), week 4, week 7, week 10. the difference between groups at week 10 is being reported | The EORTC-30\[21\] will measure QOL at each treatment cycle. 0-10 scale, higher scores mean better outcome |
| Resource Use Over Time | assessed at weeks 4,7,10. the total number of admissions was summed across all time points and participants | Any unplanned Emergency Department or hospital admission will be recorded via participant report. Higher number indicate higher resource use. |
Countries
United States
Participant flow
Recruitment details
Recruitment took place from June 2016 through August 2018 at the outpatient treatment center at the cancer center
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment
eSSET-CINV: This intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home. | 38 |
| Wait Control Group The Wait control group receives the electronic Symptom Self-Management Training- CINV (eSSET-CINV) at the last study visit. Outcomes will be compared to the Intervention group at the end of the study.
eSSET-CINV: This intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home. | 42 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | changed treatment, no longer eligible | 2 | 2 |
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 5 |
Baseline characteristics
| Characteristic | Intervention Group | Total | Wait Control Group |
|---|---|---|---|
| Age, Continuous | 69.11 years STANDARD_DEVIATION 5.311 | 69.71 years STANDARD_DEVIATION 5.684 | 70.26 years STANDARD_DEVIATION 6.012 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 77 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 35 Participants | 69 Participants | 34 Participants |
| Region of Enrollment United States | 38 participants | 80 participants | 42 participants |
| Sex: Female, Male Female | 29 Participants | 59 Participants | 30 Participants |
| Sex: Female, Male Male | 9 Participants | 21 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 38 | 1 / 42 |
| other Total, other adverse events | 0 / 38 | 0 / 42 |
| serious Total, serious adverse events | 0 / 38 | 0 / 42 |
Outcome results
Primary
Health-related Quality of Life Change Over Time
The EORTC-30\[21\] will measure QOL at each treatment cycle. 0-10 scale, higher scores mean better outcome
Time frame: assessed at baseline (week 1), week 4, week 7, week 10. the difference between groups at week 10 is being reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Health-related Quality of Life Change Over Time | 5.76 score on a scale | Standard Deviation 1.046 |
| Wait Control Group | Health-related Quality of Life Change Over Time | 5.91 score on a scale | Standard Deviation 0.893 |
Comparison: comparison at time 4p-value: 0.558t-test, 2 sided
Primary
Resource Use Over Time
Any unplanned Emergency Department or hospital admission will be recorded via participant report. Higher number indicate higher resource use.
Time frame: assessed at weeks 4,7,10. the total number of admissions was summed across all time points and participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Resource Use Over Time | 19 admissions |
| Wait Control Group | Resource Use Over Time | 11 admissions |
Comparison: descriptive comparison of resource usep-value: 0.153Chi-squared
Primary
Self-management Behaviors Over Time
An investigator-developed Symptom Management Checklist (SMC) will measure CINV self-management prevention behaviors. Participants will complete this daily at home between chemotherapy cycles. Higher numbers indicate more frequent management.
Time frame: data was assessed at weeks 4,7, 10, the mean number of behaviors (behaviors) combined at each time point is reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Self-management Behaviors Over Time | 3.68 Behaviors | Standard Deviation 7.59 |
| Wait Control Group | Self-management Behaviors Over Time | 1.38 Behaviors | Standard Deviation 4.48 |
Comparison: Descriptive comparisonp-value: 0.099t-test, 2 sided
Primary
Symptom Severity Change Over Time
Symptom Representation Questionnaire (SRQ)\[20\] , a 24-item self-report measure will be used to identify presence and severity of common treatment-related symptoms (0-10 Likert scale), including nausea and vomiting (N/V). This measure asks respondents to think about their symptoms over the past week. Higher values indicate a worse outcome
Time frame: assessed at baseline (week 1), week 4,week 7, week 10. differences between groups at week 10 are being reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Symptom Severity Change Over Time | 4.13 score on a scale | Standard Deviation 3.24 |
| Wait Control Group | Symptom Severity Change Over Time | 3.81 score on a scale | Standard Deviation 3.293 |
Comparison: Differences at week 10p-value: 0.083t-test, 2 sided