Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform

Официальное название

Study of Ribociclib (Ribo) Treatment Adherence Clinical Study Protocol

Обзор

Primary Objective: • To assess the persistence of ReX technology platform use, measured by the percentage (%) of participants who used ReX: 1) throughout the study period and 2) before the treatment discontinuation. Secondary Objective: • To evaluate the impact of the ReX technology platform on ribo treatment duration and ribo dose taking adherence as compared to control group.

Подробное описание

The ReX Platform is a class 1 FDA listed device under product code NXB Dispenser Solid Medication as a device that meets the exempt regulation 21 CFR 890.5050. and comprises the following components:

1. A disposable cartridge, a medication container supplied to participants pre-loaded with pills/capsules. The cartridge includes an integral mouthpiece, which dispenses the pill into the participant's mouth following application of an inhalation. 2. ReX Remote Digital Nurse (ReX) is a portable medication dispenser with a touchscreen and communicates with the ReX Treatment Manager via the cellular network. 3. ReX Treatment Manager (RTM) is a web application used for the collection and management of data collected by the ReX. 4. Reminders dispatched to participants and caregivers according to a predefined logic: email, SMS or via support team call. 5. Electronic Patient Reported Outcomes (ePROs) questions, tips, reminders, and groups of questions are presented to participants according to a defined logic and are collated in the ReX Treatment Manager. 6. Thresholds in cases that participant reports exceed a predefined threshold notifications via email and/or text messages will be dispatched to the specified party.

Вмешательства

• Устройство Use of ReX to dispense and monitor solid oral medication therapy.
  ReX Remote Digital Nurse comprising hand-held dispenser, disposable drug cartridge and web application (ReX Treatment Manager).

Первичные конечные точки

• Outcome MeasureReX Platform Study Group [Срок оценки: Up to 12 months]

Критерии участия

Критерии включения

Male or female, at least 18 years of age. Diagnosis of HR+ HER2- metastatic breast cancer with ribociclib treatment that begun within last 60 days.

Site has ability to dispense ribociclib in long term. Participant is able to read, understand and sign the IRB research consent for use of their data for research purposes.

Participant is able and willing to complete Patient Reported Outcome (PRO) questionnaires during the study.

Критерии исключения

• Participant has been routinely taking ribociclib for the past 60 days (without ReX platform).

Participants prescribed ribociclib for off-label indications. Participants who failed to pass the learning module during the ReX training process.

Participants who are at the end stage of their terminal illness with an anticipated life expectancy of 6 months or less.

Participants who have a significant physical disability (including poor fine motor skills, impaired visual or auditory faculties, mental disorders, or another impairment), affecting ability to provide IRB research consent or use the ReX dispensing unit effectively.

Participant is unsuited for participation in the study based on PI discretion

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 4 центра

• Allina — Minneapolis
• Texas Oncology — Austin
• Virginia Cancer Center — Richmond
• Lumicera — Madison

Идентификаторы

NCT: NCT06344416 · RXG-001-2024-CLP (Rex-002)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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