Evaluation of ReX-C® System for Medication Adherence in Oncology Patients Taking Oral Oncolytics
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|ClinicalTrials.gov Identifier: NCT04091711|
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Oncology Adherence, Medication Side Effect||Device: ReX-C system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study to Evaluate the Safety, Usability and Efficacy of the ReX-C® System in Measurement and Management of Medication Adherence and Clinical Self-reporting, in Oncology Patients Receiving Home-based Oral Oncolytic Therapy|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: ReX-C intervention
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.
Device: ReX-C system
Oral oncolytic medications are dispensed to patients via ReX-C system
- Number of safety events during administration of oral oncolytic medications by ReX-C [ Time Frame: 8 weeks ]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.
- Rate of subjects feel comfortable to use ReX-C for pill intake and side effects report [ Time Frame: 8 weeks ]
At least 70% of subjects: -
- Complete the duration of the study with Rex-C.
- Define the system as comfortable to use and are willing to continue using it for their oncolytic medication treatment.
- Rate of adherence (number of pill intakes) during treatment with ReX-C [ Time Frame: 8 weeks ]
- Up to 90% of pills are taken as prescribed
- At least 80% of subjects follow treatment instructions, and response to ReX-C reminders and alerts.
- Rate of monitoring subjects' home-based treatment by the clinical staff and satisfaction of the clinical team [ Time Frame: 8 weeks ]
At least 80% of clinical team:
- are satisfied with the use of the system and report that it is beneficial in monitoring patients' adherence and response to treatment.
- report that the system facilitates better communication with the patient and provides more appropriate real-time response compared to routine care.
- are interested in integrating the system into the oncology department for routine administration of home-based medication for oncology patients.
- Number of actual pill intakes by ReX-C system, compared with the number of prescribed pills [ Time Frame: 8 weeks ]Test if the number of pills prescribed and given to the subjects is higher than that actually taken during the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091711
|Contact: Ronit Shtrichman, Ph.Dfirstname.lastname@example.org|
|Oncology Unit, Tel Aviv Sourasky Medical Center||Not yet recruiting|
|Tel Aviv, Israel|
|Contact: Ravit Geva, MD 972-3-6973082 email@example.com|
|Contact: Tali Schaffer, MPA 972-3-6972975 firstname.lastname@example.org|
|Principal Investigator:||Ravit Geva, MD||Tel-Aviv Sourasky Medical Center|