Clinical trial NCT05826288: Oncology Care at Home for BMT and CAR-T
Official title: Design of a Patient-Centered Approach to Manage Bone Marrow Transplant Patients and CAR-T Cell Therapy in a Home Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia
Keywords: Bone Marrow Transplant (BMT)
Chimeric Antigen Receptor T-cell therapy (CAR-T)
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Reimagine Care
First posted: 2023-04-24
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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:

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.

Primary outcomes:
measure: Number of patients reporting symptoms
timeFrame: 90 Days
measure: Number of alerts generated through RPM systems
timeFrame: 30 days
measure: Number of potential febrile events detected via RPM
timeFrame: 90 Days
measure: Number of potential infections detected via RPM
timeFrame: 90 Days
measure: Number of potential neurotoxicity events detected via RPM
timeFrame: 90 Days
measure: Number of potential cytokine release syndrome (CRS) events detected via RPM
timeFrame: 90 Days
measure: Number of febrile neutropenia events confirmed by clinical evaluation
timeFrame: 90 Days
measure: Number of infections confirmed by clinical evaluation
timeFrame: 90 Days
measure: Number of neurotoxicity events confirmed by clinical evaluation
timeFrame: 90 Days
measure: Number of CRS events confirmed by clinical evaluation
timeFrame: 30 days
measure: Number of tech support contacts received from patients/caregivers
timeFrame: 90 Days
measure: Minutes RPM devices spent off-body
timeFrame: 90 Days
Secondary outcomes:
measure: Total number of patient interactions with RC
timeFrame: 90 Days
measure: EPRO patient response rates
timeFrame: 90 Days
measure: Patient retention rate
timeFrame: 90 Days
measure: Number of calls escalated to CU/UCHealth for clinical evaluation and follow-up with study participants
timeFrame: 90 Days
measure: Number of hospital admissions during study period
timeFrame: 90 Days
measure: Length of stay for hospital admissions during study period
timeFrame: up to 90 days
measure: Total days in hospital during study period
timeFrame: 90 Days
measure: Number of emergency room visits during study period
timeFrame: 90 Days
measure: Number of ICU admissions during study period
timeFrame: 90 Days
Other outcomes:
measure: Overall patient satisfaction
timeFrame: 90 days
measure: Overall caregiver satisfaction
timeFrame: up to 90 days
measure: Overall health care provider satisfaction
timeFrame: 90 days
measure: Perceived quality of life
timeFrame: 90 days
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Glen Peterson
role: PRINCIPAL_INVESTIGATOR
References: