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.
NON-PATIENT: Participants must be an oncology healthcare provider (i.e., oncologist, advanced practice provider, or oncology nurse)
NON-PATIENT: Participants must have taken care of at least one patient randomized to Arm B (CONCURxP) who had less than 85% adherence rate at 12 months as measured by the WiseBag
NON-PATIENT: Participant must speak English
NON-PATIENT: Participant must be employed at an National Cancer Institute Community Oncology Research Program (NCORP) site for at least 6 months
None
Parallel
Electronic Health Record Review
Other interventionAncillary studies
Health Promotion and Education
Other interventionReceive access to educational materials
Health Telemonitoring
Procedure/SurgeryUtilize the WiseBag medication dispenser
Interview
Other interventionComplete an interview
Patient Navigation
BehavioralReceive healthcare provider follow ups as part of the CONCURxP program
Survey Administration
Other interventionAncillary studies
Text Message-Based Navigation Intervention
Other interventionReceive personalized text message reminders related to their medication tracking as part of the CONCURxP program
Adherence using electronic monitoring
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.
Adherence using self-report
Using the12-item Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.
CDK4/6i persistence
Defined as duration from CDK4/6i initiation to discontinuation of medication against medical advice, measured as the number of days from initiation until the first day of a gap that is 30 days or longer. For each arm, mean days of persistence, and the proportion of patients who discontinue the medication earlier than 12-month will be calculated and compared between the two arms using the two-sample t-test and chi-squared test, respectively.
Symptom burden
Using the 16-item National-Comprehensive Cancer Network Functional Assessment of Cancer Therapy Breast Cancer Symptom index compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.
Quality of life
Using the PROMIS-10- version (v)1.2-Global Health compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.
Longitudinal changes of patient-reported outcomes
Generalized estimating equation will be used to assess the longitudinal change over time.
Healthcare utilization
The difference of healthcare utilization between two arms will first be evaluated using the two sample t test for the continuous variables (e.g., length of stay or number of emergency department visits), and then be modeled through the regressions to allow for the control of other covariates if needed.
Progression-free survival
Kaplan-Meier curves and log-rank testing will be used to visualize and compare progression free survival between the connected customized treatment platform (CONCURxP) patient group and enhanced usual care group, and Cox proportional hazards model will be fit to evaluate the impact of potential moderators on the associations of progression-free survival with arms.
Overall survival
Kaplan-Meier curves and log-rank testing will be used to visualize and compare overall survival between the CONCURxP patient group and enhanced usual care group, and Cox proportional hazards model will be fit to evaluate the impact of potential moderators on the associations of overall survival with arms.
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ECOG-ACRIN Cancer Research Group
Lead sponsor
National Cancer Institute (NCI)
Collaborator
