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OpenTrials
Completed

NCT Number: NCT05826288

Oncology Care at Home for BMT and CAR-T

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

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:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BioIntelliSense BioButton Rechargable

Other

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.

Other names: Remote Patient Monitoring (RPM)

Memora Health two-way patient engagement platform provided by RC

Other

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.

Primary outcomes

  1. Number of patients reporting symptoms

    Time frame: 90 Days

    Determine the number of patients reporting symptoms via EPRO

  2. Number of alerts generated through RPM systems

    Time frame: 30 days

  3. Number of potential febrile events detected via RPM

    Time frame: 90 Days

  4. Number of potential infections detected via RPM

    Time frame: 90 Days

  5. Number of potential neurotoxicity events detected via RPM

    Time frame: 90 Days

  6. Number of potential cytokine release syndrome (CRS) events detected via RPM

    Time frame: 90 Days

  7. Number of febrile neutropenia events confirmed by clinical evaluation

    Time frame: 90 Days

  8. Number of infections confirmed by clinical evaluation

    Time frame: 90 Days

  9. Number of neurotoxicity events confirmed by clinical evaluation

    Time frame: 90 Days

  10. Number of CRS events confirmed by clinical evaluation

    Time frame: 30 days

  11. Number of tech support contacts received from patients/caregivers

    Time frame: 90 Days

  12. Minutes RPM devices spent off-body

    Time frame: 90 Days

Secondary outcomes

  1. Total number of patient interactions with RC

    Time frame: 90 Days

    Total patient interactions with RC, by type, including EPRO text message conversations, video visits, and phone calls

  2. EPRO patient response rates

    Time frame: 90 Days

    The percentage of outbound text messages requesting a response that are responded to by persons activated on the program

  3. Patient retention rate

    Time frame: 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

  4. Number of calls escalated to CU/UCHealth for clinical evaluation and follow-up with study participants

    Time frame: 90 Days

  5. Number of hospital admissions during study period

    Time frame: 90 Days

  6. Length of stay for hospital admissions during study period

    Time frame: up to 90 days

  7. Total days in hospital during study period

    Time frame: 90 Days

  8. Number of emergency room visits during study period

    Time frame: 90 Days

  9. Number of ICU admissions during study period

    Time frame: 90 Days

Other outcomes

  1. Overall patient satisfaction

    Time frame: 90 days

    Number and percent of patients who report overall satisfaction with the intervention based on responses to survey items

  2. Overall caregiver satisfaction

    Time frame: up to 90 days

    Number and percent of caregivers who report overall satisfaction with the intervention based on responses to survey items

  3. Overall health care provider satisfaction

    Time frame: 90 days

    Number and percent of providers who report overall satisfaction with the intervention based on responses to survey items

  4. Perceived quality of life

    Time frame: 90 days

    Number and percent of patients who report overall improvement in perceived quality of life in responses to survey items

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Reimagine Care

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 24, 2023
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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