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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 99520 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center |
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Principal investigator decided not to pursue trial
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T cell therapy and Telemedicine | Other | All outpatient CAR-T patients will require assessments for cytokine release syndrome and neurotoxicity three times daily (every 8 hours) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine visit | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Successfully Completed Telemedicine Visits | To determine feasibility of telemedicine for outpatient cytokine release syndrome and neurotoxicity assessment. Investigators will consider telemedicine feasible in this population if at least 13 of the 15 patients successfully complete 80% of telemedicine visits. A visit will be considered successful if all measurements are recorded OR if the visit is interrupted because the participant needs to come into the CAR-T unit for assessment. If a patient is admitted, then the 80% benchmark will be calculated based on the number of days the patient was outpatient at 11 pm. The proportion meeting the 80% benchmark will be reported along with an exact 95% confidence interval. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Times a Telemedicine Visit Triggered Action | To determine how many times a telemedicine visit triggered an inpatient admission or outpatient observation status | 3 years |
| Number of Patients to Have Cytokine Release Syndrome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rakhee Vaidya, MBBS | Wake Forest University Health Sciences | Principal Investigator |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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Descriptive statistics will be used to characterize the number of cases of cytokine release syndrome based on telemedicine visits.
| 3 years |
| Number of Patients to Have Neurotoxicity | Descriptive statistics will be used to characterize the number neurotoxicities reported based on telemedicine visits. | 3 years |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |