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

Plain English Summary

Mobile Health for Adherence in Breast Cancer Patients is a Not Applicable clinical trial sponsored by ECOG-ACRIN Cancer Research Group studying Anatomic Stage IV Breast Cancer AJCC v8, Breast Carcinoma, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma. This trial tests a system called CONCURxP, which uses a smart pill dispenser (WiseBag) and text message reminders to help patients take their breast cancer medication as prescribed. It is for patients with metastatic breast cancer (Stage IV) who are taking a specific type of medication called a CDK4/6 inhibitor. Participation involves using the WiseBag device and receiving text messages, along with standard medical care. The alternative is enhanced usual care, which includes using the WiseBag but without the text message reminders. The trial aims to enroll 410 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients must be 18 years or older and fluent in English or Spanish. They must have a specific type of breast cancer (HR+ HER2- metastatic) and be starting or have recently started a CDK4/6 inhibitor medication. Patients need to have a mobile phone capable of sending and receiving texts and an email address. Individuals with certain other cancer treatments or clinical trial enrollments, or those with significant health issues (ECOG performance status >= 3), may not be eligible. This trial is studying Anatomic Stage IV Breast Cancer AJCC v8, Breast Carcinoma, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how well patients take their medication as prescribed, using a smart device to track doses, which means patients are more likely to receive the full benefit of their treat The specific primary outcome measures are: Adherence using electronic monitoring (At 12 months after initiation of medication). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial addresses the challenge of patients not taking their complex breast cancer medications consistently, aiming to improve treatment effectiveness by ensuring adherence. This research targets Anatomic Stage IV Breast Cancer AJCC v8, Breast Carcinoma, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma, where improved treatment options are needed.

Investor Insight

This trial signals a growing focus on digital health tools to improve patient adherence in oncology, a significant market with potential for improved patient outcomes and reduced healthcare costs.

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for your specific cancer type and treatment. Be prepared to use a smart pill dispenser daily and respond to text messages about your medication. Ensure you have a reliable mobile phone and email address for the study. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 410 participants

Interventions

• OTHER: Electronic Health Record Review — Ancillary studies
• OTHER: Health Promotion and Education — Receive access to educational materials
• PROCEDURE: Health Telemonitoring — Utilize the WiseBag medication dispenser
• OTHER: Interview — Complete an interview
• BEHAVIORAL: Patient Navigation — Receive healthcare provider follow ups as part of the CONCURxP program

Primary Outcomes

• Adherence using electronic monitoring (At 12 months after initiation of medication)

Secondary Outcomes

• Adherence using self-report (At 3, 6, and 12 months)
• CDK4/6i persistence (At 12 months after initiation of medication)
• Symptom burden (At baseline, 3, 6 and 12 months)
• Quality of life (At baseline and 12 months)
• Patient-provider communication (At baseline, 3, 6, and 12 months)

Full 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
* PATIENT STEP 0: Patient must be \>= 18 years of age
* PATIENT STEP 0: Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish
* PATIENT STEP 0: Patient must present with new or established pathologically proven hormone receptor (HR)+ HER2- metastatic breast cancer at the time of Step 0
* PATIENT 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

  * 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 (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
* 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 confirm that they intend to receive their care or monitoring at an NCORP site
* PATIENT STEP 0: Patient must have a personal mobile phone in which they are able and willing to send and receive text messages

  * NOTE: 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
* PATIENT STEP 0: Patient must have an email address

  * NOTE: 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
* PATIENT STEP 0: 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 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
* PATIENT STEP 1: Patient must meet all the eligibility criteria for Step 0
* PATIENT STEP 1: Patient must have signed a written informed consent form
* PATIENT STEP 1: Patient must have completed baseline survey within 30 days of the date of Step 0 Registration
* PATIENT STEP 1: Patients must have initiated their CDK 4/6 inhibitors within 30 days of the date of Step 0 registration

Trial Locations

• Fairbanks Memorial Hospital, Fairbanks, Alaska, United States
• Kingman Regional Medical Center, Kingman, Arizona, United States
• Cancer Center at Saint Joseph's, Phoenix, Arizona, United States
• Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro, Arkansas, United States
• CARTI Cancer Center, Little Rock, Arkansas, United States
• Kaiser Permanente-Anaheim, Anaheim, California, United States
• Mission Hope Medical Oncology - Arroyo Grande, Arroyo Grande, California, United States
• PCR Oncology, Arroyo Grande, California, United States
• Kaiser Permanente-Baldwin Park, Baldwin Park, California, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Metastatic Breast Cancer
• Stage IV Breast Cancer
• HER2-Negative Breast Cancer
• Hormone Receptor-Positive Breast Cancer
• Oncology
• Cancer Treatment Adherence
• Digital Health
• Medication Management
• Targeted Therapy

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