Study of Ribociclib (Ribo) Treatment Adherence Clinical Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Outcome MeasureReX Platform Study Group
研究概览
简要总结
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.
详细描述
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:
- 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.
- ReX Remote Digital Nurse (ReX) is a portable medication dispenser with a touchscreen and communicates with the ReX Treatment Manager via the cellular network.
- ReX Treatment Manager (RTM) is a web application used for the collection and management of data collected by the ReX.
- Reminders dispatched to participants and caregivers according to a predefined logic: email, SMS or via support team call.
- 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.
- Thresholds in cases that participant reports exceed a predefined threshold notifications via email and/or text messages will be dispatched to the specified party.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
A minimum of 50 and a maximum of 200 patient charts are expected to be reviewed for the control study group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Outcome MeasureReX Platform Study Group
时间窗: Up to 12 months
Numerical variables will be tabulated using mean, standard deviation, minimum, median, maximum and number of observations. Categorical variables will be tabulated using number of observations and percentages. Two interim analyses are planned for this study: Interim analysis no. 1 will summarize 50 reviewed patient charts from the control group (completed as for January 2024) Interim analysis no. 2 will summarize about 25-30 participants from the ReX group, who used ReX for at least 1 month, and will compare them to control group (planned for April 2024).
次要结局
未报告次要终点