Status:
COMPLETED
The SMART CART Study: Health Information Technology
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Leukemia, Acute
Leukemia, Lymphoblastic
Eligibility:
All Genders
3+ years
Phase:
NA
Brief Summary
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)-elicitin...
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2023
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT04051216
Start Date
December 20 2017
End Date
November 23 2023
Last Update
March 22 2024
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109