Trials / Withdrawn
WithdrawnNCT04503538
Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity
Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity Following CAR-T Infusion on an Outpatient Basis
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research is to replace one of participants' outpatient chimeric antigen receptor T-cell (CAR-T) therapy follow up visits with a virtual or "telemedicine" visit. The telemedicine visit will use an electronic tablet with a camera and a microphone that allows participants to communicate with their physicians and nurses. Participants will be provided with the necessary equipment to complete these visits.
Detailed description
Primary Objective: To determine feasibility of telemedicine for outpatient cytokine release syndrome and neurotoxicity assessment (how many telemedicine visits successfully completed per patient) Secondary Objective(s) * To determine how many times a telemedicine visit triggered an action (inpatient admission/ outpatient observation status) * To determine how many patients were detected to have cytokine release syndrome and/or neurotoxicity based on their telemedicine visit
Conditions
- Large B-cell Lymphoma
- Diffuse Large B Cell Lymphoma
- Primary Mediastinal Large B Cell Lymphoma
- High-grade B-cell Lymphoma
- Follicular Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Telemedicine visit | Participants will be provided with a Wifi-and cellular enabled electronic tablet. Additionally, participants will receive a kit that contains a thermometer, a blood pressure monitoring cuff, and a pulse oximeter (to measure oxygen saturation level). Participants will attend an educational session to learn how the telemedicine visit works. Caregivers should attend with participants and will be trained to take temperatures, blood pressures, and oxygen saturation levels. Participants will also be asked to complete a test telehealth visit. |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2023-09-01
- Completion
- 2023-11-01
- First posted
- 2020-08-07
- Last updated
- 2020-10-23
Source: ClinicalTrials.gov record NCT04503538. Inclusion in this directory is not an endorsement.