Academic Journal
Improving CDK4/6 inhibitors adherence in breast cancer using the CONnected CUstomized Treatment Platform (CONCURxP) mobile health intervention: Study protocol for ECOG-ACRIN EAQ221CD.
| Τίτλος: | Improving CDK4/6 inhibitors adherence in breast cancer using the CONnected CUstomized Treatment Platform (CONCURxP) mobile health intervention: Study protocol for ECOG-ACRIN EAQ221CD. |
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| Συγγραφείς: | Sadigh G; Chao Family Comprehensive Cancer Center, University of California Irvine, Orange, CA, United States of America. Electronic address: gsadigh@uci.edu., Duan F; Brown University - ECOG-ACRIN Biostatistics Center, Providence, RI, United States of America., Gareen IF; Brown University - ECOG-ACRIN Biostatistics Center, Providence, RI, United States of America; Brown University School of Public Health Department of Epidemiology, Providence, RI, United States of America., Hancock J; Cancer Research for the Ozarks NCORP, Springfield, MO, United States of America., Sicks JD; Brown University - ECOG-ACRIN Biostatistics Center, Providence, RI, United States of America., Thangarajah M; Brown University - ECOG-ACRIN Biostatistics Center, Providence, RI, United States of America., Meisel JL; Winship Cancer Institute, Emory University, Atlanta, GA, United States of America., Torres MA; Winship Cancer Institute, Emory University, Atlanta, GA, United States of America., Ramsey SD; Hutchinson Institute for Cancer Outcomes Research, Seattle, WA, United States of America., Wolff AC; Sidney Kimmel Cancer Center, John Hopkins University, MD, United States of America., Wagner LI; University of North Carolina at Chapel Hill, NC, United States of America., Carlos RC; Columbia University, New York, NY, United States of America., Graetz I; Winship Cancer Institute, Emory University, Atlanta, GA, United States of America. |
| Πηγή: | Contemporary clinical trials [Contemp Clin Trials] 2026 Jan; Vol. 160, pp. 108145. Date of Electronic Publication: 2025 Nov 18. |
| Τύπος έκδοσης: | Journal Article; Clinical Trial Protocol |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Elsevier Country of Publication: United States NLM ID: 101242342 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1559-2030 (Electronic) Linking ISSN: 15517144 NLM ISO Abbreviation: Contemp Clin Trials Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: New York, N.Y. : Elsevier, c2005- |
| Ιατρικοί όροι (MeSH): | Breast Neoplasms*/drug therapy , Protein Kinase Inhibitors*/therapeutic use , Protein Kinase Inhibitors*/administration & dosage , Cyclin-Dependent Kinase 4*/antagonists & inhibitors , Cyclin-Dependent Kinase 6*/antagonists & inhibitors , Medication Adherence*, Humans ; Female ; Text Messaging ; Telemedicine ; Randomized Controlled Trials as Topic ; Reminder Systems ; Quality of Life |
| Περίληψη: | Background: Cyclin-dependent kinase 4/6 inhibitors (CDKIs) improves survival when added to endocrine therapy in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. However, their complex schedule, side effects, and cost contribute to non-adherence. Methods: The EAQ221CD is a two-arm randomized controlled trial that evaluates the effectiveness of the CONnected CUstomized Treatment Platform (CONCURxP), a mobile health intervention, versus enhanced usual care (EUC) on CDKI adherence among 390 patients with breast cancer and a new CDKI prescription. Participants use a smart pouch (Wisebag) to monitor real-time adherence. CONCURxP arm patients: (1) receive text reminders for missed or extra doses; (2) receive text message surveys inquiring reasons for missed or extra doses; and (3) have access to their adherence history on a study web portal. Missed or double doses trigger alerts to the oncology team. Patients citing cost as a barrier are referred to a national non-profit financial navigation program. EUC arm patients receive educational materials on side effect management. Patients complete surveys at baseline, 3, 6, and 12 months after randomization. Our objectives are to: (1) compare 12-month CDKI adherence measured using Wisebag (primary outcome) between the two arms; (2) compare patient-reported outcomes at 12-months between the two arms, including symptom burden, quality of life, patient-provider communication, self-efficacy for managing symptoms, and financial worry; and (3) use mixed methods to describe patients' experience with the CONCURxP intervention. Our multilevel intervention will provide actionable results to improve adherence, health outcomes, and patients' experience. Trial Registration: NCT06112613. (Copyright © 2024. Published by Elsevier Inc.) |
| Competing Interests: | Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: G Sadigh, F Duan, I Gareen, J Sicks, J Meisel, M Torres, R Carlos, and I Graetz received funding from NCI for the submitted work. F Duan received personal fees from EarlyDiagnostics and Medtronic outside the submitted work. I Graetz received research grants from Pfizer and PRIME Education, LLC outside the submitted work. |
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| Grant Information: | R01 CA262312 United States CA NCI NIH HHS; UG1 CA189822 United States CA NCI NIH HHS; UG1 CA189828 United States CA NCI NIH HHS |
| Contributed Indexing: | Keywords: Breast cancer; Medication adherence; Mobile health; Remote monitoring |
| Molecular Sequence: | ClinicalTrials.gov NCT06112613 |
| Substance Nomenclature: | 0 (Protein Kinase Inhibitors) EC 2.7.11.22 (Cyclin-Dependent Kinase 4) EC 2.7.11.22 (Cyclin-Dependent Kinase 6) EC 2.7.11.22 (CDK4 protein, human) |
| Entry Date(s): | Date Created: 20251120 Date Completed: 20251226 Latest Revision: 20260919 |
| Update Code: | 20260919 |
| PubMed Central ID: | PMC12662420 |
| DOI: | 10.1016/j.cct.2025.108145 |
| PMID: | 41265834 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1559-2030 |
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| DOI: | 10.1016/j.cct.2025.108145 |