Evaluation of ReX-C® System for Medication Adherence in Oncology Patients Taking Oral Oncolytics

NCT04091711 | Suspended DMC

• 1 other identifier: RXC-034-2019-CLE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oncology; Adherence, Medication; Side Effect

Outcome Measures

Primary Outcomes (4)

• 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: - * 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.

  8 weeks

• Rate of adherence (number of pill intakes) during treatment with ReX-C

  * 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.

  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: * 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.

  8 weeks

Secondary Outcomes (1)

• Number of actual pill intakes by ReX-C system, compared with the number of prescribed pills

  8 weeks

Study Arms (1)

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.

Device: ReX-C system

Interventions

ReX-C system DEVICE

Oral oncolytic medications are dispensed to patients via ReX-C system

ReX-C intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, at least 18 years of age
• Subject is able to swallow pills and during training successfully achieves 2 administrations of "demo" pills (Tic-Tac mints) by the ReX-C.
• Subject is able to read and understand the Informed Consent Form.
• Subject was diagnosed with cancer and receives oral oncology medication.
• Subject is intended to receive Afinitor OR Sutent OR Lenvima during the 2 months study period.
• Subject takes medication therapy at home.
• Subject is fluent in one of the following languages: Hebrew, English, Russian, Arabic.

You may not qualify if:

• Subject has physical or mental disabilities which prevents their enrolment in this study, such as poor fine motor skills, impaired visual or auditory faculties, mental disorders or other impairment affecting ability to provide Informed Consent or use the ReX-C dispensing unit effectively.
• Subject failed to extract 2 Tic-Tacs with the Rex-C device during training.
• Subject is participating in another clinical study that does not permit participation in two studies simultaneously.
• Subject is at end stage or terminal illness with anticipated life expectancy of less than 3 months.

Sponsors & Collaborators

• Dosentrx Ltd.: lead

Study Sites (1)

Oncology Unit, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Neoplasms; Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ravit Geva, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 17, 2019
• Study Start: April 21, 2020
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)