Improving Medication Adherence in Breast Cancer Using a CONnected CUstomized Treatment Platform (CONCURxP)
Improving Medication Adherence in Breast Cancer Using a CONnected CUstomized Treatment Platform (CONCURxP)
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.
Inclusion Criteria:
PATIENT STEP 0: Patient must be >= 18 years of age
PATIENT STEP 0: Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish
PATIENT STEP 0: Patient must present with new or established breast cancer at the time of Step 0
PATIENT STEP 0: Patient must have initiated any of the CKD4/6 inhibitors (palbociclib or Ibrance, ribociclib or Kisqali, abemaciclib or Verzenio) within 60 days prior to registration to Step 0 or have received a prescription order with stated intent to initiate within 30 days following registration to Step 0
PATIENT STEP 0: Patient must not have been previously treated with any of the following CDK4/6 inhibitors: Palbociclib or Ibrance, ribociclib or Kisqali, and abemaciclib or Verzenio
PATIENT STEP 0: Patient must not already be enrolled in a therapeutic clinical trial that monitors CDK4/6 inhibitors
PATIENT STEP 0: Patient must not be enrolled in a symptom science clinical trial that monitors or intervenes on symptoms related to CDK4/6 inhibitors
PATIENT STEP 0: Patient must confirm that they intend to receive their care or monitoring at a National Cancer Institute Community Oncology Research Program (NCORP) site or one of the following two NCI designated Comprehensive Cancer Centers: Emory University Winship Cancer Institute or University of California Irvine Chao Family Comprehensive Cancer Center
PATIENT STEP 0: Patient must have either a personal smartphone in which they agree to receive text messages or an email address in addition to a non-smart mobile phone in which they agree to receive text messages
PATIENT STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document
PATIENT STEP 0: Patient must not have an Eastern Cooperative Oncology Group (ECOG) performance status >= 3 OR patient must not be deemed medically unable to participate in the study by the study investigators or an oncology clinician (i.e., referral to hospice)
PATIENT STEP 0: Patient must not be enrolled in other trials offering financial assistance
PATIENT STEP 1: Patient must meet all the eligibility criteria for step 0
PATIENT STEP 1: Patient must have signed a written informed consent form
PATIENT STEP 1: Patient must have completed baseline survey within 30 days after Oncology Patient Enrollment Network (OPEN) screening registration (step 0)
PATIENT STEP 1: Patients must have initiated their CDK 4/6 inhibitors either 60 days prior to or 30 days after the date of OPEN Screening Registration (Step 0)
PATIENT STEP 1: Step 1 registration must occur within 45 days of Step 0 registration
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