Oncology Care at Home for BMT and CAR-T

Leukemia Clinical Trial

Official title:

Design of a Patient-Centered Approach to Manage Bone Marrow Transplant Patients and CAR-T Cell Therapy in a Home Setting

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05826288
• Other study ID #: 22-1832.cc
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: August 22, 2024

Study information

• Verified date: July 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: August 22, 2024
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Reimagine Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall patient satisfaction	Number and percent of patients who report overall satisfaction with the intervention based on responses to survey items	90 days
Other	Overall caregiver satisfaction	Number and percent of caregivers who report overall satisfaction with the intervention based on responses to survey items	up to 90 days
Other	Overall health care provider satisfaction	Number and percent of providers who report overall satisfaction with the intervention based on responses to survey items	90 days
Other	Perceived quality of life	Number and percent of patients who report overall improvement in perceived quality of life in responses to survey items	90 days
Primary	Number of patients reporting symptoms	Determine the number of patients reporting symptoms via EPRO	90 Days
Primary	Number of alerts generated through RPM systems		30 days
Primary	Number of potential febrile events detected via RPM		90 Days
Primary	Number of potential infections detected via RPM		90 Days
Primary	Number of potential neurotoxicity events detected via RPM		90 Days
Primary	Number of potential cytokine release syndrome (CRS) events detected via RPM		90 Days
Primary	Number of febrile neutropenia events confirmed by clinical evaluation		90 Days
Primary	Number of infections confirmed by clinical evaluation		90 Days
Primary	Number of neurotoxicity events confirmed by clinical evaluation		90 Days
Primary	Number of CRS events confirmed by clinical evaluation		30 days
Primary	Number of tech support contacts received from patients/caregivers		90 Days
Primary	Minutes RPM devices spent off-body		90 Days
Secondary	Total number of patient interactions with RC	Total patient interactions with RC, by type, including EPRO text message conversations, video visits, and phone calls	90 Days
Secondary	EPRO patient response rates	The percentage of outbound text messages requesting a response that are responded to by persons activated on the program	90 Days
Secondary	Patient retention rate	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	90 Days
Secondary	Number of calls escalated to CU/UCHealth for clinical evaluation and follow-up with study participants		90 Days
Secondary	Number of hospital admissions during study period		90 Days
Secondary	Length of stay for hospital admissions during study period		up to 90 days
Secondary	Total days in hospital during study period		90 Days
Secondary	Number of emergency room visits during study period		90 Days
Secondary	Number of ICU admissions during study period		90 Days