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Awaiting next model of the device
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In recent decades, an increasing number of oral anticancer medications (oral oncolytics) have been approved. Oral oncolytics now make up to 30% of the oncology market, and their use is continually expanding.
Oral oncolytics can be a significant benefit for patients and providers. Patients who receive them often report a greater sense of control over their treatment, less interference with daily work and social activities, reduced travel time and costs, and the elimination of discomfort associated with an IV line. In rural areas, the oral route is crucial because the closest treatment center may be hours away and weather may complicate travel. Moreover, oral therapy is less invasive and reduces nursing time in infusion suites and risks to patients.
However, making cancer treatments available in oral form transfers most of the responsibility for correct administration of the drug to the patient. The more complex the oral treatment regimen, the higher the risk of errors and non-adherence. Oral Oncolytics are high-risk and high cost drugs. Hence, with this transfer of responsibility comes the need to support patients in their adherence to the directed regimen and to effectively monitor them at home.
ReX is a hand-held, mobile device intended to provide solid oral medication on patient demand according to a pre-programmed treatment protocol. ReX addresses poor patient adherence, tracks patient's response to treatment and enhances patient engagement to therapy. The system comprises a reusable drug dispensing unit (Dispenser), a disposable Cassette containing the prescribed medication, a cellphone app, and the ReX cloud. The Dispenser manages pill administration. It includes a touch screen which guides the user and presents patient-specific clinical surveys and therapy information. The Dispenser contains a chargeable battery and indicators demonstrating device and battery status; a pill window enabling pills to be viewed; operational sensors; and communication to an app on cellphones. The patient receives the Cassette from the pharmacy, pre-filled with his/her specific medication. The Cassette is inserted into the Dispenser where it is locked in place. All therapy and patient survey data are transferred to a patient-specific domain on DosentRx' proprietary web-based cloud, named Dose-E®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReX-C intervention | Experimental | Subjects use ReX-C to receive oral oncolytic medications. Adherence data, side effects and response to treatment are monitored online in real time via ReX-C cloud. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReX-C system | Device | Oral oncolytic medications are dispensed to patients via ReX-C system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of safety events during administration of oral oncolytic medications by ReX-C | Safety events include: pill overdose, pill inhalation during pill ingestion, pill malformation upon dispensing and any severe adverse events related to pill intake by the ReX-C device. | 8 weeks |
| Rate of subjects feel comfortable to use ReX-C for pill intake and side effects report | At least 70% of subjects: -
| 8 weeks |
| Rate of adherence (number of pill intakes) during treatment with ReX-C |
| 8 weeks |
| Rate of monitoring subjects' home-based treatment by the clinical staff and satisfaction of the clinical team | At least 80% of clinical team:
| 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of actual pill intakes by ReX-C system, compared with the number of prescribed pills | Test if the number of pills prescribed and given to the subjects is higher than that actually taken during the study. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ravit Geva, MD | Tel-Aviv Sourasky Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Unit, Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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Open study for subjects receiving home-based oral oncolytic treatment. Subjects receive these medication by ReX-C device. Medication adherence, treatment instructions and side effects are recorded and monitored online in real time during the Study, by the ReX-C system.
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| D001519 | Behavior |