Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)
ECOG-ACRIN Cancer Research Group
Summary
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.
Description
PRIMARY OBJECTIVE: I. To compare CDK4/6 inhibitors (CDK4/6i) adherence at 12 months after completion of the baseline survey 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 completion of the baseline survey captured through self-report between the EUC (Arm A) and CONCURxP (Arm B) arms. II. To compare CDK4/6i persistence at 12 months after completion of the baseline survey captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms. III. To compare symp…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 * NON-PATIENT: Participant must be able to provide informed consent to…
Interventions
- OtherElectronic Health Record Review
Ancillary studies
- OtherHealth Promotion and Education
Receive access to educational materials
- ProcedureHealth Telemonitoring
Utilize the WiseBag medication dispenser
- OtherInterview
Complete an interview
- BehavioralPatient Navigation
Receive healthcare provider follow ups as part of the CONCURxP program
- OtherSurvey Administration
Ancillary studies
- OtherText Message-Based Navigation Intervention
Locations (400)
- Fairbanks Memorial HospitalFairbanks, Alaska
- Kingman Regional Medical CenterKingman, Arizona
- Cancer Center at Saint Joseph'sPhoenix, Arizona
- Mercy Hospital Fort SmithFort Smith, Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroJonesboro, Arkansas
- CARTI Cancer CenterLittle Rock, Arkansas