Mobile Health for Adherence in Breast Cancer Patients

This study is looking at how a mobile health system can help patients with metastatic breast cancer (cancer that has spread to other parts of the body) take their CDK4/6 inhibitor medication as prescribed. You would either use a medication monitoring device called WiseBag along with text message reminders (CONCURxP group) or just the WiseBag device (enhanced usual care group). The main goal is to see if the CONCURxP system helps patients stick to their medication schedule better over 12 months. This study is for oncology healthcare providers who have cared for patients with less than 85% adherence to their medication.

Study design: This is an interventional study comparing two ways to help patients take their medication. It plans to enroll 410 participants, who are oncology healthcare providers.
What's involved: You would participate in an interview and receive educational materials. You would also receive healthcare provider follow-ups as part of the CONCURxP program.
Compensation: Not stated in the trial record.
Follow-up: The study measures medication adherence at 12 months after medication initiation.

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Mobile Health for Adherence in Breast Cancer Patients

Active, Not Recruiting

NAAges 18+InterventionalHealth services

ECOG-ACRIN Cancer Research Group

~390 participants

Updated 2026-08-19 on ClinicalTrials.gov

What's tested:Electronic Health Record ReviewHealth Promotion and EducationHealth TelemonitoringPatient NavigationSurvey AdministrationText Message-Based Navigation Intervention

At a glance

Recruiting sites

0 of 506 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Adherence using electronic monitoring

Measured over At 12 months after randomization

Conditions

Breast Carcinoma

Where it's being run

506 sites across 41 states

Michigan65

Wisconsin60

Minnesota50

Nevada39

California30

Colorado29

Illinois23

Ohio20

Study leadership

Gelareh Sadigh · PRINCIPAL_INVESTIGATOR · ECOG-ACRIN Cancer Research Group

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 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 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 (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: 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 STEP 0: Patient must not already be enrolled in a therapeutic clinical trial that monitors CDK4/6 inhibitors

PATIENT STEP 0: Patient must not be enrolled in a symptom science clinical trial that monitors or intervenes on symptoms related to CDK4/6 inhibitors

NOTE: If NRG-CC012CD is activated in a participating practice, and a patient meets the eligibility criteria for both EAQ221CD and NRG-CC012CD, then EAQ221CD should be offered first to patients. Only if a patient is not eligible or not interested in participating in EAQ221CD, the NRG-CC012CD can be offered

PATIENT STEP 0: Patient must confirm that they intend to receive their care or monitoring at a National Cancer Institute Community Oncology Research Program (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 STEP 0: 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 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 after Oncology Patient Enrollment Network (OPEN) screening registration (step 0)

PATIENT STEP 1: 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)

PATIENT STEP 1: Step 1 registration must occur within 45 days of Step 0 registration

What this trial measures

Adherence using electronic monitoringAt 12 months after randomization
For each arm, mean and standard deviation (SD) adherence rates for all patients will be calculated. A two-sample t-test will be used to compare CDK4/6 inhibitor (CDK4/6i) adherence between the two arms at 12 months.

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