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Health Promotion and Education / Breast Carcinoma / Patient Navigation · Interventional Study
ClinicalTrials.gov · August 19, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is an active, ongoing randomized controlled trial comparing a connected treatment platform (CONCURxP with WiseBag and text reminders) to enhanced usual care (WiseBag alone) for medication adherence in breast cancer patients taking CDK4/6 inhibitors. No results have been posted in the registry; the trial remains in recruitment-closed, follow-up phase with primary outcome data collection planned at 12 months post-randomization.
Interventional, Randomized, Parallel, Open label, Health Services Research purpose. Breast Carcinoma; age from 18 Years. Intervention: ARM A (Enhanced usual care); ARM B (CONCURxP program). Compared with: Enhanced usual care (EUC): WiseBag medication monitoring device only, without text message-based navigation intervention.. n = 390. 506 sites: United States, Puerto Rico.
Planned enrollment: 390 participants with breast carcinoma Primary outcome: Adherence using electronic monitoring at 12 months after randomization Intervention: Connected customized treatment platform (CONCURxP) combining WiseBag medication monitoring device with text message reminders for missed or extra medication events
No efficacy, safety, or adherence outcome data are posted; this is a registry record only.
Once results are available, this trial will inform whether text message-based medication reminders combined with electronic monitoring provide meaningful adherence improvement over monitoring alone in CDK4/6 inhibitor users. The finding that forgetfulness is the commonest cause of non-adherence suggests the intervention targets a modifiable barrier.
This is an active clinical trial registration with no posted results; the study design and planned enrollment are sound, but no outcome data are yet available to assess efficacy.
As stated by the source record.
Quoted from the source exactly as published.
Once results are available, this trial will inform whether text message-based medication reminders combined with electronic monitoring provide meaningful adherence improvement over monitoring alone in CDK4/6 inhibitor users. The finding that forgetfulness is the commonest cause of non-adherence suggests the intervention targets a modifiable barrier.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT06112613). This is a study registration, not published results. Lead sponsor: ECOG-ACRIN Cancer Research Group. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 390 participants (ESTIMATED). Conditions: Breast Carcinoma. Interventions: OTHER: Electronic Health Record Review; OTHER: Health Promotion and Education; PROCEDURE: Health Telemonitoring; BEHAVIORAL: Patient Navigation; OTHER: Survey Administration; OTHER: Text Message-Based Navigation Intervention. Primary outcome measures: Adherence using electronic monitoring , At 12 months after randomization. Brief summary: This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the WiseBag, to monitor medication adherence in patients with breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with breast cancer who are taking a CKD4/6 inhibitor.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.