Breast Cancer
EAQ221CD: Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)
Description
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 nonadherence. 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.
Inclusion Notes
For a full description of this trial, please go to the listing on www.clinicaltrials.gov
For Medical Personnel
Patient Eligibility Criteria for Step 0 (OPEN Screening Registration)
Patient must be ≥ 18 years of age.
Patient must be fluent in written and spoken English OR Patient must be fluent in written and spoken Spanish
Patient must present with new or established breast cancer at the time of 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.
NOTE: Patients who have been treated previously with anticancer treatments other than CDK4/6 inhibitors are eligible. NOTE: CDK4/6 inhibitors must be provided/supplied as a single agent blister pack. If the medication is supplied as capsules in a pill bottle (e.g., Ibrance capsules), patient is not eligible.
NOTE: Ribociclib (Kisgali) and Abemaciclib (Verzenio) are only available in blister packs. Palbociclib (Ibrance) is the only CDK4/6 inhibitor that might be available in a capsule formulation. However, this is an outdated formulation and is rarely prescribed as a new start. The format of ordered Palbociclib can be determined based on the prescription order.
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 must not already be enrolled in a therapeutic clinical trial that monitors CDK4/6 inhibitors.
Patient must not be enrolled in a symptom science clinical trial that monitors or intervenes on symptoms related to CDK4/6 inhibitors.
Patient must confirm that they intend to receive their care or monitoring at an 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 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
NOTE: Since mobile phones that are not smart phones cannot follow web links in a text message, people with non-smart mobile phones will also need an email address.
Patient must have the ability to understand and the willingness to sign a written informed consent document.
NOTE: Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available are not eligible.
Patient must not have an 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 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.
Patient Eligibility Criteria for Step 1 (OPEN Randomization)
Patient must meet all the eligibility criteria for Step 0 outlined in Section 3.1.
Patient must have signed a written informed consent form.
Patient must have completed Baseline Survey within 30 days after OPEN Screening Registration (Step 0).
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).
Step 1 registration must occur within 45 days of Step 0 registration.
Start Date
Friday, May 2, 2025
Principal / Contact Name
Mohmad A. Bulbul, MD