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Active, currently enrolling

Improving Medication Adherence in Metastatic Breast Cancer using a CONnected Customized Treatment Platform (CONCURxP)

NCT No.: NCT06112613

Study Type: INTERVENTIONAL

Phase: n/a

Region: Colorado

Acronym: 

Official Title

Improving Medication Adherence in Metastatic Breast Cancer using a CONnected Customized Treatment Platform (CONCURxP)

Purpose

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.

Detailed Description

Sex

Male & Female

Age Limit

Eligibility Criteria

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 participate in this study

Exclusion Criteria

PATIENT STEP 0: Patients 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: Patients must not already be enrolled in a therapeutic clinical trial that monitors CDK4/6 inhibitors;

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

NOTE: Gift cards for survey completion, parking passes, or free medication provided as part of therapeutic trials are not considered financial assistance

Keywords and/or Specific Medical Conditions

  • Obstetrics and Gynecology
  • Oncology (Adult)

Sponsors

  • ECOG-ACRIN Cancer Research Group

Clinical Area

  • Obstetrics and Gynecology
  • Oncology (Adult)

Principal Investigator

Debra Ritzwoller  

Contact Information

 - CTP Team
- ctpcollaborate@kp.org
- KPCO Institute for Health Research

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