Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
148 participants
INTERVENTIONAL
2017-12-20
2023-11-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive Care
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.
Education information system
Participants will receive a mobile tablet as an educational intervention
Activity monitor
Participants will receive at least 1 of 4 activity monitoring devices
Interview
Participants will be interviewed about their experience using the device(s)
Survey Administration
Participants will receive surveys
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Education information system
Participants will receive a mobile tablet as an educational intervention
Activity monitor
Participants will receive at least 1 of 4 activity monitoring devices
Interview
Participants will be interviewed about their experience using the device(s)
Survey Administration
Participants will receive surveys
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
3 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sung Won Choi, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00115179
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2016.051
Identifier Type: -
Identifier Source: org_study_id
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