Oncology Care at Home for BMT and CAR-T

Trial Title: Oncology Care at Home for BMT and CAR-T

NCT ID: NCT05826288

Condition: Leukemia

Conditions: Keywords:
Bone Marrow Transplant (BMT)
Chimeric Antigen Receptor T-cell therapy (CAR-T)

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: BioIntelliSense BioButton Rechargable
Description: 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.
Arm group label: Post BMT or CAR-T patients receiving care at UCHealth

Other name: Remote Patient Monitoring (RPM)

Intervention type: Other
Intervention name: Memora Health two-way patient engagement platform provided by RC
Description: 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.
Arm group label: Post BMT or CAR-T patients receiving care at UCHealth

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:

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 89 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of Colorado Hospital

Address:
City: Aurora
Zip: 80045
Country: United States

Start date: March 29, 2023

Completion date: August 22, 2025

Lead sponsor:
Agency: University of Colorado, Denver
Agency class: Other

Collaborator:
Agency: Reimagine Care
Agency class: Other

Source: University of Colorado, Denver

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05826288