University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT04051216
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.
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Notify Me3 year and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
INCLUSION:
EXCLUSION:
Participants will receive a mobile tablet as an educational intervention
Other names: Roadmap information system
Participants will receive at least 1 of 4 activity monitoring devices
Participants will be interviewed about their experience using the device(s)
Participants will receive surveys
Correlative studies
Time frame: Duration of hospital admission, up to ~6 weeks
To test the feasibility of implementing the system in the pediatric CART population. This aim will be measured quantitatively by the log-use data.
Time frame: Up to day 100 post-CART
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.
Time frame: Up to day 100 post-CART
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.
Time frame: Up to day 100 post-CART
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.
Time frame: Up to day 100 post-CART
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.
Time frame: Up to day 100 post-CART
Measured qualitatively by semi-structured qualitative interviews.
Time frame: Up to day 100 post-CART
Measured qualitatively by semi-structured qualitative interviews.
University of Michigan Rogel Cancer Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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