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Using mobile health tools to improve medication adherence in breast cancer patients

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

Not applicable Interventional Eastern Cooperative Oncology Group · NCT06112613

This study is testing a new mobile health tool that sends reminders and tracks medication use to see if it helps women with metastatic breast cancer stick to their treatment better than usual care.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment410 (estimated)
Ages18 Years and up
SexAll
SponsorEastern Cooperative Oncology Group Research network
Locations400 sites (Fairbanks, Alaska and 399 other locations)
Trial IDNCT06112613 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a connected treatment platform, CONCURxP, which includes a medication monitoring device called WiseBag and text message reminders, compared to enhanced usual care (EUC) in improving adherence to CDK4/6 inhibitors in patients with metastatic breast cancer. The study aims to measure medication adherence, persistence, symptom burden, quality of life, patient-provider communication, self-efficacy, and financial worry over a 12-month period. Participants will be monitored through electronic tracking and self-reports to assess the impact of these interventions on their treatment experience.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with hormone receptor-positive, HER2-negative metastatic breast cancer who are prescribed CDK4/6 inhibitors.

Not a fit: Patients with non-metastatic breast cancer or those not prescribed CDK4/6 inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance medication adherence and overall treatment outcomes for patients with metastatic breast cancer.

How similar studies have performed: Other studies have shown promising results with mobile health interventions for medication adherence, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Fairbanks, Alaska and 399 other locations

+350 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Anatomic Stage IV Breast Cancer AJCC v8Breast CarcinomaHER2-Negative Breast CarcinomaHormone Receptor-Positive Breast Carcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.