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.
PRIMARY OBJECTIVE: I. To compare CDK4/6 inhibitors (CDK4/6i) adherence at 12 months after randomization captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms. SECONDARY OBJECTIVES: I. To compare CDK4/6i adherence at 12 months after randomization captured through self-report between the EUC (Arm A) and CONCURxP (Arm B) arms. II. To compare CDK4/6i persistence at 12 months after randomization captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms. III. To compare symptom burden at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms. IV. To compare quality of life at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms. V. To compare patient-provider communication at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms. VI. To compare self-efficacy for managing symptoms at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms. VII. To compare financial worry at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms. EXPLORATORY OBJECTIVES: I. To assess longitudinal changes of patient-reported outcomes (self reported adherence, symptom burden, quality of life, and financial worry) from randomization to 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms. II. To compare healthcare utilization at 12 months after randomization between the EUC (Arm A) and CONCURxP (Arm B) arms. III. To describe CONCURxP (Arm B) patients experience with various implementation outcomes. OUTLINE: Patients are randomized into 1 of 2 arms. ARM A: Patients use the WiseBag medication dispenser and receive access to educational materials every 4 weeks over 12 months. ARM B: Patients use the WiseBag medication dispenser and receive personalized text message reminders, medication tracking and healthcare provider follow ups as part of the CONCURxP platform over 12 months. Patients may complete an interview over 20-30 minutes within 6 months of study completion. After completion of study intervention, patients may be followed up to 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
390
Ancillary studies
Receive access to educational materials
Utilize the WiseBag medication dispenser
Receive healthcare provider follow ups as part of the CONCURxP program
Ancillary studies
Receive personalized text message reminders related to their medication tracking as part of the CONCURxP program
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
Kingman Regional Medical Center
Kingman, Arizona, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
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.
Time frame: At 12 months after randomization
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.
Time frame: At 12 months after randomization
CDK4/6i persistence
Defined as duration from randomization to discontinuation of medication against medical advice, measured as the number of days from randomization 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.
Time frame: At 12 months after randomization
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.
Time frame: At 12 months after randomization
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.
Time frame: At 12 months after randomization
Patient-provider communication
Using the Consumer Assessment of Healthcare Providers and Systems compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.
Time frame: At 12 months after randomization
Self-efficacy for managing symptoms
Using PROMIS Item Bank v1.0 - Self-Efficacy for Managing Symptoms compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.
Time frame: At 12 months after randomization
Financial worry
Using the Comprehensive Score for Financial Toxicity compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.
Time frame: At 12 months after randomization
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