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Back|NCT06112613Recruiting
Official Title

Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

Sponsor
ECOG-ACRIN Cancer Research Group
Enrollment
410
Timeline
Jan 2024 → Jul 2027
About This Study

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

Inclusion Criteria

  • 1NON-PATIENT: Participants must be an oncology healthcare provider (i.e., oncologist, advanced practice provider, or oncology nurse)
  • 2NON-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
  • 3NON-PATIENT: Participant must speak English
  • 4NON-PATIENT: Participant must be employed at an National Cancer Institute Community Oncology Research Program (NCORP) site for at least 6 months
  • 5NON-PATIENT: Participant must be able to provide informed consent to participate in this study
  • 6PATIENT STEP 0: Patient must be \>= 18 years of age
  • 7PATIENT STEP 0: Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish
  • 8PATIENT STEP 0: Patient must present with new or established pathologically proven hormone receptor (HR)+ HER2- metastatic breast cancer at the time of Step 0
  • 9PATIENT STEP 0: Patient must have initiated any of the CKD4/6 inhibitors (palbociclib or Ibrance, ribociclib or Kisqali, abemaciclib or Verzenio) within 30 days prior to consenting to Step 0 or have received a prescription order with stated intent to initiate within 30 days following Step 0 consent
  • 10NOTE: Patients who have been treated previously with anticancer treatments other than CDK4/6 inhibitors are eligible
  • 11NOTE: 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
  • 12NOTE: Ribociclib (Kisqali) 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
  • 13PATIENT 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
  • 14PATIENT STEP 0: Patients must not already be enrolled in a therapeutic clinical trial that monitors CDK4/6 inhibitors
  • 15PATIENT STEP 0: Patient must confirm that they intend to receive their care or monitoring at an NCORP site
  • 16PATIENT STEP 0: Patient must have a personal mobile phone in which they are able and willing to send and receive text messages
  • 17NOTE: The restriction to those with mobile phone access with text messaging is based on the primary intention of the study which involves the use of text messaging to improve adherence
  • 18PATIENT STEP 0: Patient must have an email address
  • 19NOTE: The restriction to those with an email address is based on the primary intention of the study which involves patients responding to questions regarding their reasons for non-adherence after every missed dose to improve adherence
  • 20PATIENT STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document
  • 21NOTE: Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available are not eligible
  • 22PATIENT 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)
  • 23PATIENT STEP 0: Patient must not be enrolled in other trials offering financial assistance
  • 24NOTE: Gift cards for survey completion, parking passes, or free medication provided as part of therapeutic trials are not considered financial assistance
  • 25PATIENT STEP 1: Patient must meet all the eligibility criteria for Step 0
  • 26PATIENT STEP 1: Patient must have signed a written informed consent form
  • 27PATIENT STEP 1: Patient must have completed baseline survey within 30 days of the date of Step 0 Registration
  • 28PATIENT STEP 1: Patients must have initiated their CDK 4/6 inhibitors within 30 days of the date of Step 0 registration

Locations

400 sites participating in this study

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Suspended

Fairbanks Memorial Hospital

Fairbanks, Alaska 99701

Recruiting

Nicholas DiBella

Kingman Regional Medical Center

Kingman, Arizona 86401

Recruiting

John A. Ellerton

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →