About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Electronic Health Record Review
  • Health Promotion and Education
  • Health Telemonitoring
  • Interview
  • Patient Navigation
  • Survey Administration
  • Text Message-Based Navigation Intervention

Treatment groups

410 Participants
are divided into 3 treatment groups

Locations

506
Puerto Rico
Cancer Center-Metro Medical Center Bayamon00959-5060, Bayamón Puerto Rico
Puerto Rico Hematology Oncology Group00961, Bayamón Puerto Rico
Doctors Cancer Center00674, Manati Puerto Rico
Centro Comprensivo de Cancer de UPR00927, San Juan Puerto Rico

Sponsors and collaborators

ECOG-ACRIN Cancer Research Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator