Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Non-Hodgkin Lymphoma
Conditions
Keywords
continuous temperature monitoring, patient self-management, iThermonitor, Home monitoring
Brief summary
This is a pilot study to evaluate the use feasibility of the iThermonitor, a continuous temperature monitoring device, as a clinical support and patient self-management tool in the management of pediatrics patients on myelosuppressive therapies for acute leukemia and other childhood cancers.
Detailed description
Neutropenia, secondary to myelosupressive therapies, predisposes patients to significant risk for infectious complications which increases morbidity and mortality. Usually, fever is the first clinical sign of the inflammatory response to the infective process; and early detection is an indication for empiric antimicrobial therapy and further evaluation to determine risk for sepsis. Today, broad-spectrum antimicrobial therapy at the first detection of fever has helped significantly decreased the mortality associated with neutropenia in the intensive phase of chemotherapy. Therefore, early detection of fever, through regular temperature monitoring, in a neutropenic patient is critical to improved clinical outcome. Vigilance on the part of care providers and care givers is crucial to early detection. Traditionally, this is simply done through episodic oral or axillary monitoring of temperature. In this study, we propose to test the use feasibility of an innovative device that continuously monitors body temperature as a clinical decision support tool in pediatric patients undergoing myelosuppressive therapies for acute leukemias and other childhood cancers. The iThermonitor, a FDA class II device, is a high accuracy device that continuously monitors body temperature and connects to a receiver (iPad mini) via bluetooth to display body temperature data in real time. The iThermonitor is attached to the skin by a hydrogel dressing which can be changed as needed. It captures data even without connection to a receiver and it can establish connection to a paired receiver device (the iPad mini) within a range of three meters. The provided iPad mini will be pre-loaded with the iThermonitor app which will be used to pair the receiver with the iThermonitor device. The device monitors body temperature every four seconds and is able to store 10 days worth of data that can be offloaded as soon as it establishes connection with a receiver. It is able to measure temperature in the range of 25-45 degrees Celsius. Users are able to set temperature limits at which alerts for which out-of-range temperature can go off. It also provides care providers an opportunity to remotely monitor their patients' temperature in the immediate period after discharge from the hospital. Therefore, we hypothesize that the iThermonitor can serve as a feasible clinical decision support in the management of pediatric patients undergoing intensive treatments for acute leukemia and other childhood cancers. This study will be implemented as a pilot study to test the use feasibility of the iThermonitor as a clinical decision support for continuous temperature monitoring in a dyad of 25 pediatrics patients, (aged 2yrs - 17yrs) on myelosuppressive therapies for acute leukemia and other childhood cancers at the MGH Pediatric Hematology and Oncology group, and their caregivers. The iThermonitor will be used by patients and their caregivers at home over a 2-week study period starting from the day after chemotherapy. There will be two study visits: study enrollment and study closeout. The investigators have chosen to implement this study as a feasibility study because the investigators' goal is to determine if continuous temperature monitoring by the iThermonitor can work in home settings. To the investigators' knowledge, the researchers are not aware of any previous research exploring continuous temperature monitoring in pediatric oncology patients on myelosuppresive therapies. Therefore, findings from this study have the potential to advance knowledge about the management of fever in pediatric patients on myelosuppresive therapies.
Interventions
DEVICEiThermonitor
The device is a continuous temperature monitoring tool for home monitoring of temperature. Participants are asked to use this device for two weeks.
Sponsors
Dana-Farber Cancer Institute
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Dyad consists of a pediatric patient aged 2-17 years undergoing myelosuppressive therapies for acute leukemias and other childhood cancers. * Dyad also includes a caregiver, ≥ 18 years of age that is willing to participate in the study. * Ability of caregiver or patient (if old enough) to read and speak English. * If applicable, willingness of the patient to shave axillary (armpit) hair. * Caregiver (parent or legal guardian) must give informed consent for dyad participation.
Exclusion criteria
* Patient has a history of allergy to hydrogel dressing or ongoing skin diseases * Patients with ongoing febrile illness or documented infectious disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants That Successfully Used the iThermonitor | Two Weeks | This will be assessed by ability of the device to successfully capture, transmit and display the patient's body temperature data on the study iPod TouchiPad mini. To limit recall bias, subjects will be required to log the ability to view the temperature data on the iPad mini once a day for the entire duration of the study. The device will be deemed a feasible continuous temperature monitoring tool if at least 80% of study subjects are able to successfully use the iThermonitor to monitor their body temperature. A subject must be able to view temperature data on the provided iPad mini at least 80% of the time in the study to be considered successful. Time in the study here is defined as the number of days the subject spends in the study which is expected to be two weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Care Giver Anxiety | 0 & 2 weeks | The Generalized Anxiety Disorder, 7 item questionnaire was given to caregivers to see if using the device increased feelings of anxiety. This will be assessed using the GAD-7 questionnaire administered at enrollment and closeout |
| Usability, Acceptability and Satisfaction | 2 weeks | This will be assessed by questionnaires specifically designed for this study. We will be assessing ease of use, acceptability, connection and use problems like the device falling off the skin, usefulness of out-of-range temperature alerts and adverse reactions. We will also assess to see if the device helps to build caregiver self-efficacy skills in caring for the patient. |
Countries
United States
Participant flow
Recruitment details
Adolescent-Caregiver dyads were recruited from the MGH Pediatric Cancer Center or the MGH Hospital for Children (Surgical Division). Recruitment began in early 2015 and was completed by April of 2017.
Participants by arm
| Arm | Count |
|---|---|
| Temperature Monitoring Group This was a single arm usability and feasibility study. All participants were enrolled into the same group where they used the study device to monitor their temperature for two weeks. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Temperature Monitoring Group |
|---|---|
| Age, Continuous | 8 years STANDARD_DEVIATION 5 |
| Age of Caregivers | 41 years STANDARD_DEVIATION 8 |
| Employment Status of Caregivers Employed, full time | 5 Participants |
| Employment Status of Caregivers Employed, part time | 3 Participants |
| Employment Status of Caregivers Homemaker | 6 Participants |
| Employment Status of Caregivers Unemployed | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Percent of Participants That Successfully Used the iThermonitor
This will be assessed by ability of the device to successfully capture, transmit and display the patient's body temperature data on the study iPod TouchiPad mini. To limit recall bias, subjects will be required to log the ability to view the temperature data on the iPad mini once a day for the entire duration of the study. The device will be deemed a feasible continuous temperature monitoring tool if at least 80% of study subjects are able to successfully use the iThermonitor to monitor their body temperature. A subject must be able to view temperature data on the provided iPad mini at least 80% of the time in the study to be considered successful. Time in the study here is defined as the number of days the subject spends in the study which is expected to be two weeks.
Time frame: Two Weeks
Population: Caregivers of participants using the device
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Temperature Monitoring Group | Percent of Participants That Successfully Used the iThermonitor | View data at least once per day | 100 % of participants |
| Temperature Monitoring Group | Percent of Participants That Successfully Used the iThermonitor | Reported receiving out of range alerts | 75 % of participants |
| Temperature Monitoring Group | Percent of Participants That Successfully Used the iThermonitor | Reported receiving 3 or more out of range alerts | 63 % of participants |
Comparison: Descriptive statistics were used to characterize the study sample, and survey responses.descriptive analysis
Comparison: Only percent will be calculated. No statistical analysis will be conducted.
Secondary
Care Giver Anxiety
The Generalized Anxiety Disorder, 7 item questionnaire was given to caregivers to see if using the device increased feelings of anxiety. This will be assessed using the GAD-7 questionnaire administered at enrollment and closeout
Time frame: 0 & 2 weeks
Population: Caregivers of participants using the device.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Temperature Monitoring Group | Care Giver Anxiety | GAD Score_0 Weeks | No anxiety | 12 Participants |
| Temperature Monitoring Group | Care Giver Anxiety | GAD Score_0 Weeks | Mild anxiety | 3 Participants |
| Temperature Monitoring Group | Care Giver Anxiety | GAD Score_0 Weeks | Moderate anxiety | 1 Participants |
| Temperature Monitoring Group | Care Giver Anxiety | GAD Score_0 Weeks | Severe anxiety | 3 Participants |
| Temperature Monitoring Group | Care Giver Anxiety | GAD Score_2 Weeks | No anxiety | 16 Participants |
| Temperature Monitoring Group | Care Giver Anxiety | GAD Score_2 Weeks | Mild anxiety | 2 Participants |
| Temperature Monitoring Group | Care Giver Anxiety | GAD Score_2 Weeks | Severe anxiety | 1 Participants |
| Temperature Monitoring Group | Care Giver Anxiety | GAD Score_2 Weeks | Moderate anxiety | 0 Participants |
Comparison: GAD-7 scores were coded as a categorical variable as follows: mild anxiety (total score 0 to 5) and moderate/ severe anxiety (total score 6-15).~Proportion of participants with mild and moderate/ severe anxiety at enrollment and closeout was compared using Cochran's Q test.p-value: 0.13Cochran-Mantel-Haenszel
Secondary
Usability, Acceptability and Satisfaction
This will be assessed by questionnaires specifically designed for this study. We will be assessing ease of use, acceptability, connection and use problems like the device falling off the skin, usefulness of out-of-range temperature alerts and adverse reactions. We will also assess to see if the device helps to build caregiver self-efficacy skills in caring for the patient.
Time frame: 2 weeks
Population: Caregivers of participants using the device.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Satisfied with ease of use of device | Definitey True | 8 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Satisfied with ease of use of device | Mostly True | 9 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Satisfied with ease of use of device | A little true | 0 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Satisfied with ease of use of device | Not true | 2 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Easy to learn to use device | Definitey True | 13 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Easy to learn to use device | Mostly True | 6 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Easy to learn to use device | A little true | 0 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Easy to learn to use device | Not true | 0 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Felt comfortable using device | Definitey True | 13 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Felt comfortable using device | Mostly True | 3 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Felt comfortable using device | A little true | 1 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Felt comfortable using device | Not true | 1 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Able to easily monitor temperature by using device | Definitey True | 12 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Able to easily monitor temperature by using device | Mostly True | 3 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Able to easily monitor temperature by using device | A little true | 2 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Able to easily monitor temperature by using device | Not true | 2 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Feel confident monitoring temperature with device | Definitey True | 10 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Feel confident monitoring temperature with device | Mostly True | 4 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Feel confident monitoring temperature with device | A little true | 2 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Feel confident monitoring temperature with device | Not true | 2 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Device helpful stating discussions with doctor | Definitey True | 5 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Device helpful stating discussions with doctor | Mostly True | 2 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Device helpful stating discussions with doctor | A little true | 5 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Device helpful stating discussions with doctor | Not true | 5 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Using device makes me feel more connected to team | Definitey True | 2 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Using device makes me feel more connected to team | Mostly True | 7 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Using device makes me feel more connected to team | A little true | 4 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Using device makes me feel more connected to team | Not true | 6 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Would recommend device | Definitey True | 10 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Would recommend device | Mostly True | 5 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Would recommend device | A little true | 2 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Would recommend device | Not true | 2 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Found app very useful in monitoring temperature | Definitey True | 10 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Found app very useful in monitoring temperature | Mostly True | 4 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Found app very useful in monitoring temperature | A little true | 4 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Found app very useful in monitoring temperature | Not true | 1 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Found out-of-range temp alert function useful | Definitey True | 5 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Found out-of-range temp alert function useful | Mostly True | 5 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Found out-of-range temp alert function useful | A little true | 5 Participants |
| Temperature Monitoring Group | Usability, Acceptability and Satisfaction | Found out-of-range temp alert function useful | Not true | 4 Participants |
Comparison: Descriptive statistics were used to characterize the study sample, and survey responses. All analysis was conducted using STATA version 14.2 with an alpha of 0.05 set a priori. Since this was an exploratory study with descriptive statistics, a complete case analysis approach was adopted for this studyp-value: 0.05descriptive analysis