|5R01CA262312-02 Interpret this number
|University Of California-Irvine
|Improving Medication Adherence Using a Connected Customized Treatment Platform (CONCURXP)
Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) nearly doubles progression-free survival and increases
overall survival when added to endocrine therapy in hormone receptor-positive (HR+), human epidermal
growth factor receptor 2–negative (HER2-) metastatic breast cancer (MBC). The growing incidence of MBC
among younger women highlights the need to optimize adherence to complex medication regimens proven to
increase survival. The complex dosing schedule of CDK4/6is along with high cost is thought to contribute to
non-adherence. There is limited evidence on the impact of CDK4/6i nonadherence on survival, symptom
burden, or quality of life. As healthcare transitions to a greater dependence on telemedicine, and with the
increasing penetration of text-enabled mobile phones across every segment of the population, we propose to
test an innovative personalized multilevel mHealth intervention to improve CDK4/6i adherence by conducting a
randomized controlled trial of a CONnected CUstomized Treatment Platform (CONCURxP) versus enhanced
usual care (EUC). The CONCURxP trial will recruit 390 English- or Spanish- speaking adult women with HR+
HER2- MBC and a new prescription for a CDK4/6i, who have a mobile phone with text messaging and are
treated in one of the participating NCI Community Oncology Research Program (NCORP) practices. To
objectively measure CDK4/6i adherence, all enrolled patients will receive a smart pillbox. CONCURxP arm
patients in addition to usual care will: (1) receive automated text reminders for missed or extra doses that are
signaled by the smart pillbox; (2) respond to text messages citing the reason for each incident of CDK4/6i non-
adherence; and (3) can view dosage history on a study web-portal. Missed or double doses beyond a
predefined threshold will trigger an email notification to a designated member of the oncology provider team,
who will be prompted to contact the patient to address the issue to close the communication loop. If
nonadherence is due to cost, providers will be trained to refer patients to the Patient Advocate Foundation, a
national non-profit financial navigation program. EUC patients will have access to educational materials to
improve side effect management. Patients will receive the interventions for 12 months and complete surveys at
baseline, 3, 6, and 12 months after enrollment. Our goals are to: (1) compare CDK4/6i adherence; and (2)
patient-reported outcomes (PROs) including symptom burden, quality of life, patient-provider communication,
self-efficacy for managing symptoms, and financial worry at 12 months between CONCURxP and EUC arms;
(3) use mixed methods to describe the patient and provider experience with the CONCURxP intervention; and
(4) explore healthcare utilization, progression-free, and overall survival at 12 months in CONCURxP patients
compared to EUC. The primary endpoint is adherence at 12 months, defined as the proportion of days patients
took CDK4/6i according to the prescribed frequency, measured by pillbox. Our novel multilevel mHealth
intervention will provide valuable and actionable results to improve health outcomes and patient experience.
Improving palbociclib adherence among women with metastatic breast cancer using a CONnected CUstomized Treatment Platform: A pilot study.
, Meisel J.L.
, Byers K.
, Robles A.
, Serrano L.
, Jung O.S.
, Coleman D.
, Yeager K.A.
, Graetz I.
Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners, 2023 Dec; 29(8), p. 1957-1964.