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NCT06112613 · ClinicalTrials.gov registry record · NA
Mobile Health for Adherence in Breast Cancer Patients
A NA study of Breast Carcinoma and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by ECOG-ACRIN Cancer Research Group.
- Recruiting
- Registry status
- NA
- Development phase
- 410
- Enrollment target
- 20
- Study locations
NCT06112613: Recruiting NA study of Breast Carcinoma and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by ECOG-ACRIN Cancer Research Group.
NCT06112613 is a NA study of Breast Carcinoma and Anatomic Stage IV Breast Cancer AJCC v8 that is actively recruiting participants, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 410 participants, below the 767-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06112613, a NA study of Breast Carcinoma and Anatomic Stage IV Breast Cancer AJCC v8, is actively recruiting participants, sponsored by ECOG-ACRIN Cancer Research Group.
- RECRUITING
- Registry status
- NA
- Development phase
- 410 participants
- Enrollment target
- 20
- Study locations
Study 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 metastatic 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 metastatic breast cancer who are taking a CKD4/6 inhibitor.
Primary Outcome
For each arm, mean and standard deviation (SD) adherence rates for all patients will be calculated. A two-sample t-test will be used to compare CDK4/6 inhibitor (CDK4/6i) adherence between the two arms at 12 months.
Conditions Studied
Interventions
- OTHER Electronic Health Record Review
- OTHER Interview
- OTHER Health Promotion and Education
- BEHAVIORAL Patient Navigation
- PROCEDURE Health Telemonitoring
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- Mercy Cancer Center - Elk Grove - Elk Grove
- Kaiser Permanente-Fontana - Fontana
- Kaiser Permanente - Harbor City - Harbor City
- Kaiser Permanente-Irvine - Irvine
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Kaiser Permanente West Los Angeles - Los Angeles
- Contra Costa Regional Medical Center - Martinez
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- CARTI Cancer Center - Little Rock
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
Alaska
- Fairbanks Memorial Hospital - Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 410 participants |
| Start Date | 2024-01-26 |
| Est. Completion | 2027-07-31 |
| Phase | NA |
What NCT06112613 shows while recruiting
NCT06112613 is an interventional study that assigns participants to a tested intervention. The registered 410 participants enrollment target is mid-sized for trials with a published cap, below the 767-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (47% lower).
The record links to 4 conditions, with Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Electronic Health Record Review is the first listed.
NCT06112613 names 20 study sites across 4 states, led by California, Arkansas, Arizona.
Frequently Asked Questions
What is clinical trial NCT06112613 about?
NCT06112613 is a clinical study titled "Mobile Health for Adherence in Breast Cancer Patients". 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...
What is the current status of trial NCT06112613?
This trial is currently recruiting. It is a NA study. The enrollment target is 410 participants. The study started on 2024-01-26. Estimated completion is 2027-07-31.
What conditions does trial NCT06112613 study?
This clinical trial studies the following conditions: Breast Carcinoma, Anatomic Stage IV Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma.
What interventions are being tested in trial NCT06112613?
The interventions under investigation include: Electronic Health Record Review (OTHER), Interview (OTHER), Health Promotion and Education (OTHER), Patient Navigation (BEHAVIORAL), Health Telemonitoring (PROCEDURE).
Who is sponsoring clinical trial NCT06112613?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06112613 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06112613's enrollment target sits among peer trials
410 23rd of 106 higher than 83 of 106 other Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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