Oncology Care at Home for BMT and CAR-T
Design of a Patient-Centered Approach to Manage Bone Marrow Transplant Patients and CAR-T Cell Therapy in a Home Setting
1 other identifier
interventional
11
1 country
1
Brief Summary
To assess the potential for successfully using technology-assisted in-home oncology care to provide improved care coordination and management, and appropriate referral to treatment for patients receiving bone marrow transplant (BMT) or chimeric antigen receptor (CAR) T-cell therapy (CAR-T). The technology-assisted in-home oncology care program includes remote patient monitoring (RPM), telemedicine, and home-based health care services.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable leukemia
Started Mar 2023
Shorter than P25 for not_applicable leukemia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2023
CompletedStudy Start
First participant enrolled
March 29, 2023
CompletedFirst Posted
Study publicly available on registry
April 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFebruary 21, 2025
February 1, 2025
4 months
March 23, 2023
February 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Number of patients reporting symptoms
Determine the number of patients reporting symptoms via EPRO
90 Days
Number of alerts generated through RPM systems
30 days
Number of potential febrile events detected via RPM
90 Days
Number of potential infections detected via RPM
90 Days
Number of potential neurotoxicity events detected via RPM
90 Days
Number of potential cytokine release syndrome (CRS) events detected via RPM
90 Days
Number of febrile neutropenia events confirmed by clinical evaluation
90 Days
Number of infections confirmed by clinical evaluation
90 Days
Number of neurotoxicity events confirmed by clinical evaluation
90 Days
Number of CRS events confirmed by clinical evaluation
30 days
Number of tech support contacts received from patients/caregivers
90 Days
Minutes RPM devices spent off-body
90 Days
Secondary Outcomes (9)
Total number of patient interactions with RC
90 Days
EPRO patient response rates
90 Days
Patient retention rate
90 Days
Number of calls escalated to CU/UCHealth for clinical evaluation and follow-up with study participants
90 Days
Number of hospital admissions during study period
90 Days
- +4 more secondary outcomes
Other Outcomes (4)
Overall patient satisfaction
90 days
Overall caregiver satisfaction
up to 90 days
Overall health care provider satisfaction
90 days
- +1 more other outcomes
Study Arms (1)
Post BMT or CAR-T patients receiving care at UCHealth
EXPERIMENTALParticipants will be recruited for this study from among three discrete patient populations: * Allogeneic BMT patients receiving care at UCHealth who are planning to reside in the Denver metro area within 45 minutes of the Anschutz Medical Campus (AMC) for at least 90 days post-transplant. * Autologous BMT patients receiving care at UCHealth who are planning to reside in the Denver metro Area within 45 minutes of the AMC for at least 30 days post-transplant. * CAR-T patients receiving care at UCHealth who are planning to reside in the Denver metro area within 45 minutes of the AMC for at least 30 days post treatment.
Interventions
This study uses the BioIntelliSense BioButton Rechargeable for RPM, in combination with the BioSync mobile app on participants' mobile phones for data transmission, augmented by use of the BioHub as a backup transmission device. RPM monitoring of device data is accomplished through use of the AlertWatch software system.
The Memora Health platform is designed to automate complex care workflows, making them simple for patients and clinicians to navigate. It utilizes a multi-modal communications system that primarily relies on two-way text messaging and artificial intelligence.
Eligibility Criteria
You may qualify if:
- Age 18 years to 89 years old
- Bone marrow transplant recipients (allogeneic and autologous) or CAR-T patients
- Determined by care provider to be stable for discharge to home setting for outpatient care according to clinical practice standard operating procedures (SOPs)
- Residing in the Denver metro area for the duration of the study within 45 minutes of the AMC
- Has in-home caregiver support 24/7 (i.e., does not live alone)
- Has self-reported reliable telephone and home internet service and a stable wireless network
- Patient agrees to not submerge the BioButton Rechargeable device in more than 3 feet of water or submerge for longer than 30 minutes at a time.
- Patient owns or possesses, as the primary user with reliable daily access, a mobile device (iOS or Android) capable of running the study's mobile applications and accepting the terms and conditions
- Patient has SMS texting capacity and an unlimited texting plan or other plan sufficient for study text messaging without undue patient burden
- Patient is willing to complete and log a self-check of temperature twice daily and return the log to the study team at the end of the study
- Patient is willing to be available for the duration of the study
- Patient has access to reliable transportation to the hospital 24/7
You may not qualify if:
- Patients will be excluded from study participation if the PI or designated care provider believes study participation would not be in the patient's best interest for clinical reasons.
- Patients may also be excluded from study participation if in the opinion of the PI they have a medical condition that may impede their ability to adhere to the study protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Reimagine Carecollaborator
Study Sites (1)
University of Colorado Hospital
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Glen Peterson
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2023
First Posted
April 24, 2023
Study Start
March 29, 2023
Primary Completion
August 4, 2023
Study Completion
December 31, 2024
Last Updated
February 21, 2025
Record last verified: 2025-02