Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform
- Conditions
- Any Solid Oral Medication
- Registration Number
- NCT06344416
- Lead Sponsor
- Dosentrx Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria:<br><br>Male or female, at least 18 years of age. Diagnosis of HR+ HER2- metastatic breast cancer<br>with ribociclib treatment that begun within last 60 days.<br><br>Site has ability to dispense ribociclib in long term. Participant is able to read,<br>understand and sign the IRB research consent for use of their data for research purposes.<br><br>Participant is able and willing to complete Patient Reported Outcome (PRO) questionnaires<br>during the study.<br><br>Exclusion Criteria:<br><br>• Participant has been routinely taking ribociclib for the past 60 days (without ReX<br>platform).<br><br>Participants prescribed ribociclib for off-label indications. Participants who failed to<br>pass the learning module during the ReX training process.<br><br>Participants who are at the end stage of their terminal illness with an anticipated life<br>expectancy of 6 months or less.<br><br>Participants who have a significant physical disability (including poor fine motor<br>skills, impaired visual or auditory faculties, mental disorders, or another impairment),<br>affecting ability to provide IRB research consent or use the ReX dispensing unit<br>effectively.<br><br>Participant is unsuited for participation in the study based on PI discretion<br><br>
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcome MeasureReX Platform Study Group
- Secondary Outcome Measures
Name Time Method