Oncology Care at Home for BMT and CAR-T

Not Applicable

Active, not recruiting

• Conditions: Leukemia
• Interventions: Other: BioIntelliSense BioButton Rechargable; Other: Memora Health two-way patient engagement platform provided by RC

• Registration Number: NCT05826288
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

The objective of this study is 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.

The study focuses on evaluating the technical feasibility, operational feasibility, and perceived patient, caregiver and healthcare provider experience of a combined package of technology-assisted in-home oncology care services to monitor for febrile neutropenia, infection, cyotokine release syndrome, neurotoxicity or other symptomatic episodes needing management up to 90 days post allogeneic BMT, up to 30 days post autologous BMT, and up to 30 days post CAR-T. It includes the following specific aims and hypotheses:

Study Timeline

• Study First Submitted: 2023-03-23
• Study Start: 2023-03-29
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-04-24
• Primary Completion: 2023-08-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Study Completion: 2025-08-22

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• 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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post BMT or CAR-T patients receiving care at UCHealth	BioIntelliSense BioButton Rechargable	Participants 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.
Post BMT or CAR-T patients receiving care at UCHealth	Memora Health two-way patient engagement platform provided by RC	Participants 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.

Primary Outcome Measures

Name	Time	Method
Number of potential infections detected via RPM	90 Days
Number of potential neurotoxicity events detected via RPM	90 Days
Minutes RPM devices spent off-body	90 Days
Number of neurotoxicity events confirmed by clinical evaluation	90 Days
Number of alerts generated through RPM systems	30 days
Number of potential cytokine release syndrome (CRS) events detected via RPM	90 Days
Number of CRS events confirmed by clinical evaluation	30 days
Number of patients reporting symptoms	90 Days	Determine the number of patients reporting symptoms via EPRO
Number of febrile neutropenia events confirmed by clinical evaluation	90 Days
Number of tech support contacts received from patients/caregivers	90 Days
Number of potential febrile events detected via RPM	90 Days
Number of infections confirmed by clinical evaluation	90 Days

Secondary Outcome Measures

Name	Time	Method
EPRO patient response rates	90 Days	The percentage of outbound text messages requesting a response that are responded to by persons activated on the program
Length of stay for hospital admissions during study period	up to 90 days
Number of ICU admissions during study period	90 Days
Total number of patient interactions with RC	90 Days	Total patient interactions with RC, by type, including EPRO text message conversations, video visits, and phone calls
Number of emergency room visits during study period	90 Days
Patient retention rate	90 Days	The percentage of patients that remain actively engaged with the program by exchanging at least one text message or having at least one telehealth encounter with the VCC per week
Number of hospital admissions during study period	90 Days
Number of calls escalated to CU/UCHealth for clinical evaluation and follow-up with study participants	90 Days
Total days in hospital during study period	90 Days

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States