Oncology Care at Home for BMT and CAR-T

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Leukemia

Treatments: Other: BioIntelliSense BioButton Rechargable; Other: Memora Health two-way patient engagement platform provided by RC

Study type: Interventional

Funder types: Other

Identifiers

NCT05826288

22-1832.cc

Details and patient eligibility

About

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.

Full 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:

Enrollment: 11 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Post BMT or CAR-T patients receiving care at UCHealth

Experimental group

Description:

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.

Treatment:

Other: Memora Health two-way patient engagement platform provided by RC

Other: BioIntelliSense BioButton Rechargable