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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00115179 | Other Identifier | University of Michigan Rogel Cancer Center |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This study evaluates the feasibility of using two information technology tools in patients undergoing Chimeric Antigen Receptor T-cell (CART) therapy and other Cytokine Release Syndrome (CRS)-eliciting treatments such as CD123 BITE. The first is an Apple iPad® application called the BMT Roadmap, which shows information about the participant's health. The second is a wearable activity monitoring device. Health information technology tools such as Roadmap system and the activity monitoring device may enable caregivers and patients to become more active participants in their healthcare.
100 patients will be asked to participate in the wearable device portion of the study. 100 caregivers will be asked to participate in the Roadmap (iPad) portion of the study.
Each caregiver will be provided with an iPad to use the BMT Roadmap system. Patients and/or caregivers are free to use this tool as much as they would like on their own time while in the hospital. The hospital care team will collect the iPad when the patient is discharged and ready to go home. Patients and caregivers will also be asked to take three surveys that will ask about their feelings and thoughts about the Roadmap application. The surveys will be completed when patients are admitted for their CART or other CRS-eliciting therapy, when they get discharged from the hospital and around 100 days after they receive their therapy.
In addition to the use of the BMT Roadmap, this study will include around 7-10 interviews about participants' opinions on the two tools and their experience in the therapy process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care | Experimental | Caregivers receive the Roadmap information system loaded on an Apple iPad® for use during the inpatient hospitalization of CART therapy. The Roadmap information system consists of 5 modules personalized to the CART patient: laboratory studies, medications, clinical trial enrollment, healthcare providers, and criteria for discharge. Patients wear an activity monitoring device on days 0-100. Patients wear the device as long as they can each day to monitor physical activity level, sleep/wake patterns, skin temperature, heart rate and respiratory rate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education information system | Behavioral | Participants will receive a mobile tablet as an educational intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of caregivers that log onto the BMT Roadmap at least once per day for a minimum of 4 of the 7 days of the week while the patient is in the hospital. | To test the feasibility of implementing the system in the pediatric CART population. This aim will be measured quantitatively by the log-use data. | Duration of hospital admission, up to ~6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who are able to wear the activity monitoring device(s) approximately 12 hours of the day. | To test the feasibility of implementing a non-invasive, wearable activity monitoring device in the pediatric CART population. This aim will be measured quantitatively by the log-use data. | Up to day 100 post-CART |
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INCLUSION:
EXCLUSION:
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| Name | Affiliation | Role |
|---|---|---|
| Sung Won Choi, MD, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000072936 | Fitness Trackers |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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| Activity monitor | Other | Participants will receive at least 1 of 4 activity monitoring devices |
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| Interview | Other | Participants will be interviewed about their experience using the device(s) |
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| Survey Administration | Other | Participants will receive surveys |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Percentage of patients from whom longitudinal samples of blood, urine and stool are collected, for correlative studies. |
Feasibility of collecting longitudinal samples of blood, urine and stool from study population. Samples will be used to perform an exploratory analysis of the relationship between these biomarkers and clinical status, Roadmap and wearable device information. |
| Up to day 100 post-CART |
| Caregiver activation/participation compared to reference population to measure the impact of Roadmap information system and wearable monitoring device using survey instrument scores of Parent-Patient Activation Measure (P-PAM) as a composite measure. | Descriptive statistics will be calculated for each Patient Activation Measure (PAM) score and stratified into the appropriate level of activation. Results will be compared with a published sample. Univariate analyses will be performed to assess associations between PAM and demographic, social, and environmental characteristics of the parent (type of insurance, marital status, number of children in household), disease-related characteristics of the patients (age, disease, disease status at CART), satisfaction (Press Ganey, Usefulness), caregiver burden (CQOLC), mood (POMS), anxiety (STAI), stress (Impact of Event Scale-Revised), miscarried helping (HHI), and experiential avoidance (PAAQ). Pearson's correlation (and other suitable measures of association for categorical variables) will be used to determine the nature and significance of association between each variable and Parent-PAM scores. This analysis will not be powered to detect any statistically meaningful differences. | Up to day 100 post-CART |
| Care providers' satisfaction with the Roadmap information system and non-invasive, wearable activity monitoring device health IT tools for patients and their families/caregivers. | Qualitative interviews of BMT healthcare providers (physicians, nurses, advanced practitioners, social workers, psychologist, nutritionist, and pharmacologist). This is information gathering only. There is no reference population for this. | Up to day 100 post-CART |
| Presence of care process redesign associated with the Roadmap information system and wearable monitoring devices. | Measured qualitatively by semi-structured qualitative interviews. | Up to day 100 post-CART |
| Quality of care process redesign associated with the Roadmap information system and wearable monitoring devices. | Measured qualitatively by semi-structured qualitative interviews. | Up to day 100 post-CART |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |