Clinical trial · Interventional
The SMART CART Study: Health Information Technology
NCT04051216CI-TRIAL-00075341completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Acute | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Leukemia, Lymphoblastic | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activity monitor | Other | — | UNRESOLVED |
| Education information system | Behavioral | — | UNRESOLVED |
| Interview | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive Care
- description
- 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.
- interventionNames
- Behavioral: Education information system
- Other: Activity monitor
- Other: Interview
- Other: Survey Administration
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- measure
- 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.
- timeFrame
- Duration of hospital admission, up to ~6 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
Show eligibility criteria text
INCLUSION: * Caregiver (age 18 years or older) of any patient eligible to undergo therapy in BMT or hematology/oncology that elicits CRS including CART and CD123 BITE and any patient (age 3 years or older) eligible to undergo therapy in BMT or hematology/oncology that elicits CRS including CART and CD123 BITE will be recruited during the "Pre-CART Workup" stage in the outpatient setting. * CAREGIVER PARTICIPANTS: Caregiver (age 18 years or older) of a patient who will be hospitalized to receive therapy which elicits CRS in the University of Michigan Mott Children's Hospital Adult or Pediatric BMT Units. The age range of patients typically transplanted in the Pediatric BMT unit is 0-25 years, while the Adult BMT unit transplants those older than 25. Caregivers with children (patients) who are younger than 3 years of age may be eligible to participate even though their children are too young to assent or participate themselves. * PATIENT PARTICIPANTS: Patient (age 10 years or older) who will be hospitalized to receive or after receiving CART therapy will be given the opportunity to assent/consent and participate in the study. With his/her permission, the patient will also be provided with their own iPad® Roadmap information system to use. Qualitative interviews will be conducted in patients (age 10 years or older) with their assent/consent along with neurocognitive testing. Patients (age 10-17.9 years) will be asked to complete surveys that have been validated in this age group and that offer insight into the usefulness of the Roadmap along with neurocognitive testing. Patients (18 years or older) will be asked to complete surveys along with neurocognitive testing. The patient will also be provided with their own non-invasive, wearable activity monitoring device(s) that will track activity and rest levels. Patients 3-9 years old will be enrolled with parental consent but will not be approached for assent. These patients will not be eligible to participate in the survey or interview portions of the study, however, they will be eligible for sample collection, wearable devices and neurocognitive testing. * Ability to speak and read proficiently in English (the study's instruments have not been translated and validated in languages other than English) * Willing and able to provide informed consent * Willing to comply with study procedures and reporting requirements EXCLUSION: * Not willing and able to provide informed consent. * Not willing to comply with study procedures and reporting requirements.
References
Publications (0)
Data not yet available
No reference posted for this study.